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Category Archives: Parkinson’s Treatment

Titan to Start Phase 1/2 Study of Subdermal Implant to Deliver Requip to Parkinson’s Patients – Parkinson’s News Today

Posted: September 1, 2017 at 6:49 pm

The U.S. Food and Drug Administration (FDA) has given a green light to Titan Pharmaceuticals to begin a first-in-human clinical trial testing an implant that provides continuous release of ropinirole to treatParkinsons signs and symptoms.

In the open-labelPhase 1/2 trial (NCT03250117), which is nowrecruiting, roughly 20 Parkinsons disease patients taking levodopa along with oral ropinirole (marketed as Requip) will be switched to the subdermal, or under the skin, implant for three months. They will continue using levodopa.

This study will measure how muchropiniroleis released in the blood during the three months, and evaluate possibleside effects caused by the new drug delivery route. It will also look for evidenceof treatment efficacy through changes inthe severity of Parkinsons disease in participants. The trial will take place at three or more U.S. sites, although only one in Michigan is currently registered.

New treatments that offer continuous delivery of medication providing non-pulsatile stimulation of dopamine receptors in the brain appear to have some advantages over oral formulations, Dr.Aaron Ellenbogenof the Michigan Institute of Neurological Disorders said in a press release.

The ProNeura implants with ropinirole could potentially offer an important treatment option for continuous drug delivery that overcomes the fluctuating drug levels associated with oral administration of ropinirole, and we look forward to conducting this study, said Ellenbogen, the studys principal investigator at the site nearDetroit.

Requip, a dopaminergic agent, is approved in the U.S. as immediate-release and extended-release tablets to treat suchsigns and symptoms of Parkinsons asstiffness, tremors, muscle spasms, and poor muscle control. The immediate release formulation is also approved to treatrestless leg syndrome.

But some Parkinsons patients develop motor complications and dyskinesia, or uncontrolled and jerky movements, after taking oral Requipfor several years, due to fluctuations in blood levels of the medication. Dyskinesia can be anything from a slight tremor of the hands to an uncontrollable movement of the upper body or lower limbs.

The implant is based on Titans ProNeura technology, and is designed to continuously release a consistent dose of ropinirole for three months or more, avoiding the shiftsin bloodconcentrations when ropinirole istaken as a tablet.

While oral formulations of ropinirole have greatly benefitted those suffering from Parkinsons disease, many patients develop serious motor complications and dyskinesias after several years, due to the peak-trough fluctuations of medication in the blood, said Kate Beebe, PhD, executive vice president and chief development officer at Titan.

Our ropinirole implant is designed to provide continuous, non-fluctuating therapeutic levels of medication for up to three months, potentially offering patients and clinicians a more effective treatment option, Beebe said. We thank the FDA for their timely review and comments on the IND and clinical protocol.

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We May Be Able to Treat Parkinson’s Disease With an Implant – Fortune

Posted: August 25, 2017 at 5:41 pm

Last year, I reported on Titan Pharmaceuticals and partner Braeburn Pharmaceuticals’ milestone Food and Drug Administration (FDA) approval for an implant to treat opioid addiction. Using Titan’s “ProNeura” platform technologycomposed of matchstick-sized implants inserted in the upper armthe companies won marketing approval for Probuphine, which dispenses a medication called buprenorphine for up to six months. This therapy both treats pain while weaning users off of more powerful addictive opioids and presents one option for tackling the opioid crisis.

Now, Titan has been given the FDA go-ahead to launch trials for a long-acting implant with a commonly used Parkinson’s disease drug called ropinirole. The automated delivery system could be particularly useful for Parkinson’s patients, as the company explains, since a drop-off in symptom control medication levels can make life extremely difficult for people suffering from the disease. Parkinson’s symptoms may include tremors, stiffness, and loss of balance.

“While oral formulations of ropinirole have greatly benefitted those suffering from Parkinson’s disease, many patients develop serious motor complications and dyskinesias after several years, due to the peak-trough fluctuations of medication in the blood,” said Titan executive vice president and chief development officer Kate Beebe in a statement. “Our ropinirole implant is designed to provide continuous, non-fluctuating therapeutic levels of medication for up to three months, potentially offering patients and clinicians a more effective treatment option.”

The business strategy is an interesting one. Rather than focusing on the costly and risk-fraught endeavor of new drug development, Titan is essentially looking to make existing treatments more effectivein essence, building a better medical mousetrap.

This essay appears in today’s edition of the Fortune Brainstorm Health Daily. Get it delivered straight to your inbox.

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Parkinson’s Treatment by Internet Can Match In-person Visits … – Parkinson’s News Today

Posted: at 5:41 pm

Virtual house calls with a neurologist can be as effective as in-person visits for Parkinsons disease patients, offering convenience and comfort, a clinical trial indicates.

The study, National randomized controlled trial of virtual house calls for Parkinson disease, was published in the journal Neurology.

The internet has led to what is known as telemedicine, or virtual house calls between physicians and patients in the treatment of certain conditions.

But whilepilot efforts have suggested that virtual house calls are feasible, valuable to patients, and have similar clinical outcomes to in-person care in Parkinsons disease, they arent used much in chronic conditions like Parkinsons, researchers said.

The team decided to conduct a clinical trial(NCT02038959) to evaluate whether virtual house calls are feasible for Parkinsons patients and can improve their health.

Researchers also wanted to know how virtual house calls affect the quality of patients care and their quality of life, compared with in-person visits. And they wanted to know whether virtual house calls saved patients time, the need for them to travel, and can reduce caregiver burden.

The proportion of patients who completed at least one virtual visit, as well as the number of virtual visits they completed on time, were the two factors researchers considered when evaluating feasibility. The team used patient feedback to determine virtual house calls effectiveness. The feedback yardstick was scores on Parkinsons Disease Questionnaire39, the most widely used patient reporting scale.

Among the 927 patients who showed interest in the study, 195 were randomized to receive in-person care with their usual provider. Some of the 195 also received video teleconference visits over 12 months with a neurologist they had never seen.

Ninety-eight percent of the 195 patients completed at least one virtual visit. Patients also completed 91 percent of the 388 virtual visits that researchers scheduled. Those results indicated that its feasible to provide remote neurological care to Parkinsons patients.

The virtual calls also saved patients an average of 169 minutes and 38 miles per visit. And 55 percent of patients said they preferred virtual calls over in-person visits.

There was no improvement in patients quality of life, however, and researchers reported no quality of care or caregiver-burden benefits. But 83 percent of patients said they were satisfied with their care, and 73 percent said they had seen a doctor in person in the past year.

So the fact that adding the virtual house calls to peoplescare did not improve their quality of life could be because a large proportion were already seeing a specialist and were satisfied with that care, Dr. Ray Dorsey of the University of Rochester Medical Center in New York said in a press release. Of course, its also possible that virtual house calls are not enough to improve quality of life.

The researchers noted that their study included mostly well-educated patients who were familiar with the internet. It also excluded the nearly 25 percent of patients who lived in nursing homes. Those factors were potential limitations of the research, the team said.

But they concluded that for patients with Parkinsons disease, virtual house calls from a neurologist are feasible and do not significantly change quality of life compared to in-person visits.

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Parkinsons Disease Information from Parkinsons.org

Posted: August 21, 2017 at 2:43 pm

Parkinson’s disease is one of a larger group of neurological conditions called motor system disorders. Historians have found evidence of the disease as far back as 5000 B.C. It was first described as “the shaking palsy” in 1817 by British doctor James Parkinson. Because of Parkinson’s early work in identifying symptoms, the disease came to bear his name.

In the normal brain, some nerve cells produce the chemical dopamine, which transmits signals within the brain to produce smooth movement of muscles. In Parkinson’s patients, 80 percent or more of these dopamine-producing cells are damaged, dead, or otherwise degenerated. This causes the nerve cells to fire wildly, leaving patients unable to control their movements. Symptoms usually show up in one or more of four ways:

Though full-blown Parkinson’s can be crippling or disabling, experts say early symptoms of the disease may be so subtle and gradual that patients sometimes ignore them or attribute them to the effects of aging. At first, patients may feel overly tired, “down in the dumps,” or a little shaky. Their speech may become soft and they may become irritable for no reason. Movements may be stiff, unsteady, or unusually slow.

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Teletherapy as Effective as In-Person Treatment for Parkinson’s Disease – PsychCentral.com

Posted: August 19, 2017 at 5:46 pm

Teletherapy via videoconferencing appears to be just as effective in treating patients with Parkinsons disease as traditional in-person therapy, according to a new study published in the journal Neurology.

The two greatest barriers to appropriate care for Parkinsons patients are distance and disability. Most physicians who specialize in movement disorders are located in academic medical centers in large urban areas, while most patients tend to live in suburban and rural areas. Patients who have impaired mobility and driving ability are faced with the added challenge of making frequent trips to the doctors office a task that becomes more difficult as the disease progresses.

In fact, an estimated 40 percent of people with Parkinsons disease do not see a neurologist soon after diagnosis. This puts them at a much greater risk of falls leading to hip fractures, ending up in a nursing home or hospital, and even death. As the population ages, the challenge of providing care for all of these individuals will become ever greater, as it is projected that the number of people with Parkinsons disease will double by 2030.

The findings are based on the Connect.Parkinson project, a nationwide program that links neurologists with remote Parkinsons patients.

The aim of the study was to determine whether telemedicine would allow neurologists to deliver care to patients in the comfort of their homes. A total of 195 individuals with Parkinsons were selected to participate in the study. Patients either received care through their primary care physician or had that care supplemented with up to four visits via video conference with a neurologist they had not seen before.

Parkinsons disease particularly lends itself to telemedicine because many aspects of the diagnosis and treatment of the disease are visual, meaning that the interaction with the doctor mainly involves listening to the patient and observing them perform certain tasks such as holding their hands out or walking.

The researchers found that the telemedicine visits were just as effective as in-person visits in the doctors office, with the quality of life reported by the participants as no better or worse for people who received care in their homes compared with those who received standard care. In fact, the virtual house calls saved patients an average of 169 minutes and nearly 100 miles of travel per visit.

Virtual house calls for chronic diseases like Parkinsons are not only as effective as in-person care but broader adoption of this technology has the potential to expand access to patient-centered care, said Ray Dorsey, M.D., the David M. Levy Professor of Neurology at the University of Rochester Medical Center (URMC) and lead author of the study.

We now have the ability to reach anyone, anywhere but the promise and benefits of telemedicine will not be fully realized until the changes are made in Medicare policy.

Unfortunately, widespread adoption of this technology is hindered by federal healthcare policies. Approximately two-thirds of Parkinsons patients are on Medicare which does not reimburse for in-home telemedicine care. Legislation has been introduced in Congress to allow Medicare to expand reimbursement for telemedicine.

We can shop, bank, make travel reservations, take classes, and buy groceries via the internet from the comfort of our own homes, but too many patients still cannot access health care, said Dorsey.

Telemedicine is an option if you are a veteran, a member of the Armed Services, a Medicaid beneficiary, or a Canadian, but not if you have a chronic condition and are a Medicare beneficiary.

Source: University of Rochester Medical Center

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APA Reference Pedersen, T. (2017). Teletherapy as Effective as In-Person Treatment for Parkinsons Disease. Psych Central.Retrieved on August 19, 2017, from https://psychcentral.com/news/2017/08/19/teletherapy-as-effective-as-in-person-treatment-for-parkinsons-disease/124885.html

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Survey: Patients With Parkinson’s Disease, MS Report Efficacy From Medical Cannabis – eNews Park Forest

Posted: August 18, 2017 at 9:46 pm

Sativex is the cannabis-based mouth spray developed by UK-based GW Pharmaceuticals. (Source: herb.co)

Fort Collins, CO(ENEWSPF)August 18, 2017. Patients suffering from Parkinsons disease and multiple sclerosis report that cannabis effectively mitigates many of their symptoms, according to survey data published in the journal Complementary Therapies in Medicine.

Five hundred and ninety-five subjects responded to an online questionnaire hosted on the Michael J. Fox Foundation and the National Multiple Sclerosis Society webpages. Respondents reported that cannabis was highly effective (6.4 on a scale from zero to 7) at providing symptom management, and 59 percent of participants said that they had reduced their use of prescription drugs since initiating medical marijuana treatment. Those respondents who identified themselves as medical cannabis users reported lower overall levels of disability compared to non-users, specifically in the domains of memory, mood, and fatigue.

Placebo-controlled clinical trials assessing the use of both whole-plant cannabis and/or cannabis-derived extracts in patients with MS have consistently shown efficacy in the mitigation of spasticity and other symptoms. A plant cannabis-derived spray, Sativex, is available by prescription for the treatment of MS in Canada, the United Kingdom, and in several other countries.

Patients with PD consistently report subjective benefits from cannabis, particularly for the mitigation of tremors and bradykinsea (slowness of movement).

Full text of the study, Cannabis use in people with Parkinsons disease and Multiple Sclerosis: A web-based investigation, appears in Complementary Therapies in Medicine.

Source: http://norml.org

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Diabetes Drug May Be Used as a Treatment for Parkinson’s Disease – Healthline

Posted: at 6:45 am

Exenatide has worked well for people with diabetes. Now, researchers want to see how good a treatment it can be for people with Parkinson’s disease.

In medicine, researchers often find that a drug intended for one use is also effective in different, unexpected ways.

In a recent study, researchers from University College London (UCL) found that exenatide a medication thats been approved by the Food and Drug Administration (FDA) since 2005 for people with type 2 diabetes has the potential to modify Parkinsons disease.

The study, published in the Lancet and funded by the Michael J. Fox Foundation for Parkinsons Research (MJFF), had researchers testing exenatide in people with Parkinsons.

In a test that pitted exenatide versus a placebo, researchers found that those who were taking exenatide had better motor function after their treatment.

This improvement persisted after a 12-week follow-up. For those who had taken a placebo, motor function showed a marked decline.

The findings have promising implications for people with Parkinsons disease, a long-term degenerative condition for which there is currently no cure.

Exenatide has an interesting history.

Dr. Dilan Athauda, first author of the UCL study, described the drugs past in an email to Healthline. Athauda is a specialist registrar in neurology and a clinical research fellow at the National Hospital for Neurology and Neurosurgery.

Exenatide is a synthetic version of a naturally occurring protein exendin-4 that was originally discovered by Dr. John Eng in the early 1990s in the saliva of the Gila monster, a venomous lizard native to the Southwestern United States, he wrote.

Engs team found that exendin-4 was similar to a human hormone, glucagon-like peptide-1 (GLP-1). The substance is secreted in humans after eating a meal to stimulate insulin secretion, which lowers blood sugar.

In humans, GLP-1 quickly breaks down and its effects dont last long. But studies showed the effects of exendin-4 (the Gila monster protein) lasted longer in humans.

This eventually led to approval from the FDA for the synthetic version of this protein exenatide for those with type 2 diabetes.

During the trials on its road to FDA approval, researchers found that exendin-4 had neuroprotective properties. This could help rescue degenerating cells and protect neurons.

Based on this preclinical evidence, Professor Tom Foltynie of the UCL Institute of Neurology supervised a small trial of exenatide in people with Parkinsons.

The team found that patients treated with exenatide for one year (in addition to their usual medication) had less decline in their motor symptoms when assessed without their medication compared to the control group (just on their usual medication) and this advantage over the control group was still present one year after stopping exenatide injections, wrote Athauda.

Based on these results, the UCL team expanded their research and conducted a larger, double-blind, placebo-controlled trial.

Athauda told Healthline that patients treated with exenatide showed a reduced rate of decline compared with those who had taken a placebo.

He cautioned, however, that patients did not notice any difference in their quality of life.

Still, the findings show promise. UCL researchers would like to expand their research to include a larger group of participants across multiple centers.

Since Parkinsons disease progresses slowly, Athauda notes that longer-term studies could give a clearer idea of how exenatide works with these patients.

Overall, I think the results support accumulating data that this drug (and class of drugs) should be the subject of further investigation to assess their potential as a future therapy for Parkinsons disease, he wrote.

Using exenatide as a potential treatment for Parkinsons disease is an example of drug repurposing or repositioning, and is an important pathway to bring new treatments to patients in a timely and cost-effective manner, however it is an inexact science, wrote Athauda.

Exenatide has been FDA-approved for diabetes for years, and it has an excellent track record. But it does have some adverse side effects in people with Parkinsons. These are mostly gastrointestinal issues like nausea and constipation.

While we are optimistic about the results of our trial, there is more investigation to be done, and it will be a number of years before a new treatment could be approved and ready for use, said Athauda in a release.

The results of the UCL study show promise, but the road to clinical approval is a long one.

Using approved therapies for one condition to treat another, or drug repurposing, offers new avenues to speed Parkinsons therapeutic development, said Dr. Brian Fiske, senior vice president of research programs at MJFF, in a release. The results from the exenatide studies justify continued testing, but clinicians and patients are urged not to add exenatide to their regiments until more is known about their safety and impact on Parkinsons.

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Diabetes Drug Improves Parkinson’s Motor Symptoms in Small Trial – Alzforum

Posted: at 6:45 am

17 Aug 2017

August brought some welcome news for the Parkinsons community: results from a Phase 2 clinical trial suggested the diabetes drug exenatide halted the worsening of motor problems in people in moderate stages of the disease. As reported in the Lancet on August 3, motor symptoms slightly improved in those taking the drug for nearly a year, while the placebo group declined. Notably, a portion of the benefits of exenatide, aka Bydureon, persisted for 12 weeks after participants had stopped taking the drug. The results come with caveats–as the trial included only 62 patients, all from a single center. Some commentators were not convinced the results point to modification of the disease, as patients had the greatest motor improvements at the beginning of the trial. However, even as the authors and commentators stressed that the findings must be replicated in larger trials, optimism was in the air. Thomas Foltynie of University College London headed thetrial.

I think it is an exciting new era in PD treatment, commented Ted Dawson of John Hopkins University School of Medicine in Baltimore. Naturally the trial needs to be replicated in a larger cohort of de-novo patients. This should prime the pump for development of this class of drugs for the treatment of PD and related neurodegenerativedisease.

Nigel Greig of the National Institutes of Health in Bethesda, a co-author on the paper, called the findings highly promising. This approved type 2 diabetes mellitus drug holds potential to impact the course of the disease itself, and not merely the symptoms of PD, he wrote toAlzforum.

Telling Slopes? Motor scores worsened (increased) in the placebo group (red), and slightly improved in the exenatide group (blue), whose scores were worse at baseline. Left shows absolute scores, right shows change. [Courtesy of Athauda et al., The Lancet,2017].

Paul Aisen of the University of Southern California in San Diego did not think the data support a disease modifying mechanism. In general, the results look typical for symptomatic therapy: rapid improvement followed by a trajectory that parallels the placebo curve, he wrote to Alzforum. A larger study with a longer wash-out period and a pre-defined delayed start analysis plan would be necessary to address the question ofdisease-modification.

As a glucagon-like peptide-1 (GLP-1) receptor agonist, exenatide triggers insulin secretion and boosts glucose metabolism. The drug and others in its class are approved for diabetes treatment, but have also assembled a portfolio of neuroprotective benefits in experimental models (for review, see Li et al., 2016). Among them, GLP-1 receptor agonists boost neurogenesis, quell neuroinflammation, and protect dopaminergic neurons from damage inflicted by mitochondrial toxins in animal models of PD (Bertilson et al., 2008 , Cao et al., 2016, and Jan 2009 news). This preclinical data motivated researchers to test exenatide in a small, open-label study beginning in 2010. Motor symptoms improved in people with moderate PD who took the drug for a year. This continued two months after exenatide treatment stopped, while patients who took only L-Dopa continued to decline (Jun 2013 news). This proof-of-concept trial lacked a proper placebo group, which the researchers rectified with the current randomized, double-blind, placebo-controlledtrial.

First author Dilan Athauda and colleagues conducted the trial at the Leonard Wolfson Experimental Neuroscience Center at University College London. All of the 62 patients had been on dopaminergic treatment, and were starting to experience wearing-off effects of the therapy. Protocol algorithms randomized the volunteers 1:1 to take placebo or 2 mg exenatide, which was self-administered via subcutaneous injection once weekly for 48 weeks. A 12-week wash-out period, without treatment,followed.

The trials primary outcome was a change in scores on part 3 of the Movement Disorders Society Unified Parkinsons Disease Rating Scale (MDS-UPDRS) at 60 weeks, following the 12 week wash-out. Measurements for this outcomewhich were taken every 12 weeks in addition to baseline and 60 weekswere recorded in the early morning in the off-medication state, when patients had not taken their dopaminergic therapy for at least eight hours. Part 3 of the MDS-UPDRS tests motor symptoms, such as tremor, bradykinesia, and gait disturbances. In addition, the researchers measured a number of secondary outcomes, including cognition, quality of life, and mood, when patients were on their normal medications. The researchers also conducted several exploratory measurements, including DaTscan PET to assess dopamine transporter activity, and timed motor tests conducted in both on- and off-medication states. They measured concentrations of the drug in blood and urine every 12 weeks, and checked cerebrospinal fluid for exenatide at 12 and 48weeks.

Randomization of small trials can produce unbalanced groups by chance, and that was indeed the case with this one. Compared to the 30 participants assigned to the placebo group, the 32 patients randomized to take exenatide were on average four years older, had higher MDS-UPDRS part 3 scores at baseline, and were taking lower doses of dopaminergic treatment. In this scale, higher scores mean worse motorfunction.

At 48 weeks, off-medication scores in MDS-UPDRS part 3 had worsened by 1.7 points in the placebo group, while participants taking exenatide had improved by 2.3 points compared to baseline. At 60 weeks, the placebo group had declined by 2.1 points, while volunteers taking exenatide maintained an improvement of 1 point better than baseline. Therefore, while the placebo group steadily declined throughout the course of the trial, the exenatide group got better, and maintained a portion of that benefit even after 12 weeks without the drug. While the exenatide group outperformed their baseline scores at 60 weeks, their scores did slip after stoppingtreatment.

Notably, in keeping with the worse baseline motor performance in the exenatide group, the placebo group outperformed the treatment group throughout the trial. Athauda emphasized to Alzforum that a change in scores, rather than a difference in absolute scores between groups, was the predefined primary outcome measure. Other commentators agreed that the worse average scores in the treatment group did not detract from the studys main finding: that motor scores actually improved in people takingexenatide.

Changing the slope of that curve is the holy grail of PD research, commented Patrik Brundin of the Van Andel Institute in Grand Rapids, Michigan. He added that because both the exenatide and placebo groups started the trial 6.4 years after their PD diagnosis, the poorer baseline motor scores of the exenatide group suggest they had a more rapidly progressing disease. This makes their improvement all the more impressive and convincing, hesaid.

Though participants taking exenatide clocked a net improvement in motor scores between baseline and 60 weeks, most of the gain occurred during the first twelve weeks, and waned as the trial went on. Brundin speculated that acute pharmacological effects, such as enhanced dopamine production, could be responsible for this initial burst of improvement. He added that other effects of the drug, such as neuronal repair, neuroprotection, and quenching damaging neuroinflammation, may exert benefits moregradually.

According to Christian Hlscher of Lancaster University in England, the finding that exenatides benefits outlasted the 12-week washout period suggests the trial achieved the ultimate of outcomes: disease modification. This is proof that exenatide makes a long-term impact, as opposed to just patching up symptoms, he told Alzforum. Weve finally struckgold.

Not everyone was convinced. Suzanne Craft of Wake Forest School of Medicine in Winston-Salem, North Carolina, took a more cautious tone, pointing out that motor scores started to deteriorate after treatment stopped. A longer follow-up period would be helpful in determining whether there is a rebound effect, or whether there is truly some persistent benefit to exenatide treatment that might support a disease modifying mechanism, she wrote toAlzforum.

David Standaert of the University of Alabama at Birmingham felt there could be other explanations as well. While the improvement in off-medication state could be a disease-modifying effect, it could also be a long-lasting symptomatic effect, or an effect on the pharmacodynamics of the othermedications.

The authors themselves were also conservative in their interpretation of the results. It might be tempting to view persistent benefits detectable after the washout period as evidence of disease modification, they wrote in the papers discussion. However, they noted that 12 weeks may have been insufficient time to eliminate unexpected long-lasting symptomatic effects. For example, symptomatic relief may promote participants to take up or maintain healthy behaviors such as exercise, which could have long-termbenefits.

Despite improvements on the MDS-UPDRS part 3, no significant changes on secondary outcome measures were noted, including quality of life. This is not entirely surprising, Brundin said, given the short duration of the trial, small motor improvements, and relatively moderate symptoms the participants started out with. He and Hlscher speculated that more noticeable benefits could emerge in longertrials.

Exenatide also did not boost motor performance in participants while they were under the influence of dopaminergic treatment. The failure of this exploratory measure indicates that exenatide only effects symptoms when participants are in an artificial state, namely when they are not taking their usual medications, Standaert pointedout.

As another exploratory outcome, the researchers measured dopamine transporter activity via DaTscan at baseline and 60 weeks. They found that while activity in dopaminergic regions declined in both groups, it did significantly less so in the exenatide group. In a separate commentary co-authored with Brundin and Richard Wyse of Cure Parkinsons Trust in London, the authors cautioned against over interpretation of these imaging results, pointing out that they were not adjusted for multiple comparisons (Athauda et al., 2017).

Exenatide seemed well-tolerated. Adverse eventsincluding gastrointestinal symptoms, weight loss, nausea, and loss of appetiteoccurred with similar frequency in the treatment and placebo groups. People in the exenatide group lost more weight on average than those in the placebo group, but the researchers observed no significant correlation between the degree of weight loss and primary outcome. Of the eight serious adverse events that occurred throughout the trial, six were in the exenatide group, though the authors state that none were considered related to treatment. One person had to discontinue exenatide due to elevation in the pancreatic enzyme amylase at 12 weeks. Hyperamylasemia has been documented in diabetics taking the drug, but caused no symptoms in the patient in thistrial.

Regardless of their interpretation of the results, all authors and commentators Alzforum consulted called for a longer, multi-center Phase 3 trial of the drug in PD patients. The source of funding for such an expensive trial is up uncertain, especially given that AstraZenecas patent on exenatide recently expired. The Michael J Fox Foundation sponsored the present trial. Because this drug and others in its class are already approved for diabetes treatment, it is possible that some doctors could prescribe them off-label to people with PD. However, Brundin and other commentators emphasized that most physicians would be appropriately unwilling to do so without further proof of the drugs effects on thedisease.

Standaert, a clinician, agreed, pointing to the need for larger trials. Outside of a clinical trial, I would not recommend treatment with exenatide to any of my patients with PD at this time. The benefits are uncertain at best, and there are clearly risks of therapy.JessicaShugart

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Mirapex: A Miracle Treatment with Troubling Effects for Some – Parkinson’s News Today

Posted: at 6:45 am

Mirapex(pramipexole), a common treatment forParkinsons disease, is believed to work by boosting the action of whatever dopamine is available, which is low in people with Parkinsons. It is a dopamine agonist that directly stimulates nerves in the brain that are not naturally being stimulated by dopamine.

Several years ago, my doctor diagnosed me with Parkinsons. Immediately, he placed me on Mirapex(pramipexole dihydrochloride). I cant say that Ive had a problem with this particular medication, except that sometimes I felt as if I could lie down right where I was and have a glorious nap about half an hour after taking it.

Although I havent had many side effects, others have. Just as PD affects each individual differently, so do the medications.

My reactions were mild, and yet at each checkup, my doctor did not fail to ask if I had started having addictive behaviors with gambling, shopping, or sex. Fortunately, I was able to answer no to his questions, but that is not the case with three people I became acquainted with through a PD support group I belong to through Facebook.I am going to call them Cora, Jim, and Carl.

Coras father is a PD patient and has taken Mirapex for two years. During this time, he developed serious gambling problems, delusions, and hallucinations.

Meanwhile, Jim had been taking Mirapex for restless leg syndrome (RLS), often a complication of PD. He read up on some undesirable side effects that included compulsive gambling, excessive spending, and compulsive, excessive sexual behavior.

What disturbed Jim most was that patients taking Mirapexoften are unaware that a change is occurring. Jim began engaging in several of these atypical behaviors. He was unaware that they were actually becoming addictive behaviors. Fortunately for Jim, his doctor recognized that Mirapex was causing the addictions. Jim thought he was the only one with these side effects until his doctor put him in touch with Carl.

Carl first noticed his bowel movements had changed and constipation was regular. He gained 40 pounds in the first five months and couldnt sleep. He understood it was the medication but had another issue: He was embarrassed by the things he couldnt seem to quit doing. He never read the informational insert inside the drug box. He was just following the doctors orders.

Carl began to lose control sexually, and his internet use became an outlet for improperbehavior. He was ashamed and felt isolated in his problem. He went to seea new neurologist and discovered he wasnt alone. Several other PD patients who were prescribed Mirapex were dealing with similarissues. [Such extreme side effects in Mirapex users are considered unusual, but are known and reported. Heres theMayo Clinics list of common and uncommon reactions; heres a similar oneonDrugs.com. The possibility of unusual urges gambling, compulsive eating, compulsive buying, and increased sex drive is alsonoted on Mirapexs onlineinformation page.]

Carls neurologist diagnosed the problemand hestoppedthe drug. Sheryl, however, lost everything to gambling before learningthe likely cause ofher problem. After her house, savings, retirement, husband and children were gone, and she found herself taking money from the church offering, she sought help. Her doctor, too, took her off Mirapex, and her gambling urges ceased.

I also came to know a woman Ill call Becky. Herstory isnt as devastating, unless you count Beckys painting the outside of her house 17 times in one year.

While the incidenceof such behavior is low psychiatric effects are estimated to involve 0.1% to 1% of all PD and RLS Mirapex users it istroubling. So why do physicians continue to prescribe such a drug?

According to the website CanadianMedsUSA, Mirapex eases the symptoms of Parkinsons disease, a progressive disorder marked by muscle rigidity, weakness, shaking, tremor, and eventually difficulty with walking and talking. Parkinsons disease results from a shortage of the chemical messenger dopamine in certain areas of the brain. Mirapex is believed to work by boosting the action of whatever dopamine is available.

With relief like that, its hard to not want to take it. It also is a miracle drug of sorts for RLS, providing relief almost instantaneously.

Chances are that your doctor will prescribe Mirapex if your diagnosis is PD or RLS, and most likely you will experience some sort of side effect while youre on it. It is extremely important to keep the communication open between you and your doctor and to make sure youre checking in regularly.

Each case is different. Dont hesitate to seek help if you begin to notice changes or to feel different. You may be fine. It may be nothing. Nevertheless,your health is ultimately your responsibility and hesitation could be costly. Be proactive in your care. It could be what saves your family, your job, and your life.

***

Note:Parkinsons News Todayis strictly a news and information website about the disease. It does not provide medical advice, diagnosis ortreatment. This content is not intended to be a substitute for professional medical advice, diagnosis, ortreatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those ofParkinsons News Todayor its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to Parkinsons disease.

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Global Kinetics Corp Secures First US Patent For Its Digital Health System – Markets Insider

Posted: August 15, 2017 at 1:40 pm

Melbourne, Australia and Minneapolis, Minn., Aug. 14, 2017 /PRNewswire/ — Global Kinetics Corporation (GKC), a digital health company revolutionizing the management of Parkinson’s disease, announced today it has recently received Notice of Allowance for U.S. patent application 12/997540, protecting the company’s lead product, the Personal KinetiGraph (PKG) (Parkinson’s Kinetigraph outside of the U.S.) system, which the company is marketing in the U.S. The patent application pertains to the objective measurement of bradykinesia. Bradykinesia, or slowness of movement, is one of the most common symptoms, and a defining feature, of Parkinson’s disease. The capacity to continuously measure this movement symptom underpins the PKG system.

“The allowance of this application supports GKC’s continued progress in the commercialization of our novel, U.S. FDA-cleared PKG system, which is being used to support the management of Parkinson’s disease in over 215 clinics in 16 countries around the world,” said GKC’s global head of business development and legal affairs, Michelle Goldsmith. “We are aggressively pursuing clinical and commercial milestones that will ultimately enable us to make measurable change in the lives of people with Parkinson’s.”

The PKG system, developed by Professor Malcolm Horne and Dr. Rob Griffiths following many years of research at Melbourne’s Howard Florey Institute and Monash University, incorporates a patient-friendly wrist-worn device to record body movements over several days as people go about their daily lives. The PKG system is the only commercially available mobile health technology which provides clinically meaningful measurement of the key symptoms of Parkinson’s using cloud-based proprietary algorithms that measure bradykinesia, dyskinesia, tremor, and the relationships of these to medication timing, sleep and exercise.

Inaccurate assessment of Parkinson’s symptoms may result in patients experiencing uncontrolled symptoms, reducing their quality of life and increasing healthcare costs. By adding the PKG system into a patient’s routine care, treating clinicians now have an effective tool that assists them to augment their clinical assessment with GKC’s proprietary objective data, captured by the PKG watch over seven days.

“GKC has long held the view that measurement is key to optimal management in Parkinson’s. Our algorithms underpin GKC’s ability to provide clinically meaningful and actionable information about Parkinson’s symptoms to clinicians,” explained Professor Horne, GKC’s co-founder and chief scientific officer.

The results of a recent study show the PKG system detected 85% of Parkinson’s patients previously considered “controlled” by their treating physician were, in fact, uncontrolled and experiencing treatable symptoms. The study also showed that without the PKG, one third of the patients that the PKG system detected as having treatable symptoms would have been missed by expert movement disorder specialists (MDS).1 When patients, who were classified as uncontrolled, were treated per their physicians’ recommendations, their outcomes improved, including the subgroup where only the PKG, not the MDS, detected the need for treatment changes.1

GKC is currently conducting studies to establish the value of the PKG system in improving the entire advanced therapy pathway from more efficient referrals to better optimization on therapy. Early evidence suggests the PKG may enhance the DBS pathway, this research is ongoing.2

About Global Kinetics Corporation (GKC) and the Parkinson’s KinetiGraphTM System (PKGTM)

GKC, recognized as a Top 10 Most Innovative Health Company by the Fast Company Awards 2017, is a commercial-stage digital health company revolutionizing the management of Parkinson’s.

The company’s PKG System is a patient-friendly, algorithm-based system that records body movements and other symptoms over the course of many days and creates data-driven reports that empower more personalized treatment and management decisionswith the goal of leading to a higher quality of life for patients.

The PKG System continues to be accepted as a first line clinical system and is the only FDA-cleared and clinically validated digital health technology that can provide continuous and objective measurement of patients’ symptoms in everyday environments. This includes the continuous and objective measure of bradykinesia (or slowness of movement), the most clinically important symptom of Parkinson’s disease.

In addition to increased use in routine clinical care for Parkinson’s disease, Global Kinetics continues to pursue partnerships with major pharmaceutical and medical technology to help measure the efficacy of new and advanced therapies, as well as use in clinical trials, telehealth, remote monitoring and other augmented platform opportunities.

For more information, visit: http://www.globalkineticscorporation.com.

View original content:http://www.prnewswire.com/news-releases/global-kinetics-corp-secures-first-us-patent-for-its-digital-health-system-300503487.html

SOURCE Global Kinetics Corporation

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