Generalised tonic-clonic seizures are one of the most dangerous types of seizure.[2] The seizures start with a loss of consciousness and a sudden contraction of the muscles, which can cause the person to fall down (tonic phase). This is followed by violent convulsions (clonic phase) until the muscles finally relax.[3] The filing in this new indication is based on data from Study 332,[4] a double-blind, randomised, placebo-controlled, multicentre, parallel-group trial to evaluate the efficacy and safety of adjunctive perampanel for refractory PGTC seizures. 164 people (>12 years old) with PGTC seizures, despite treatment with one to three concomitant AEDs were randomised to receive perampanel or placebo in a 1:1 ratio. Results demonstrate that perampanel significantly reduces PGTC seizure frequency and improved responder rates (50% reduction in seizure frequency per 28 days in the maintenance period, relative to baseline), the study's two primary outcome measures, when compared to placebo. The most frequent adverse events (10% in the perampanel arm and greater than placebo) are dizziness, fatigue and headache, irritability and somnolence. The adverse event profile is similar to that for other perampanel studies.[4] "Tonic-clonic seizures are very serious and can have a profound effect on quality of life for people with … Continue reading
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