Adjunctive perampanel for refractory partial-onset seizures
نویسندگان
چکیده
Methods: This was a multicenter, double-blind, placebo-controlled trial (ClinicalTrials.gov identifier: NCT00699972). Patients ( 12 years, with ongoing seizures despite 1–3 AEDs) were randomized (1:1:1) to once-daily perampanel 8 mg, 12 mg, or placebo. Following baseline (6 weeks), patients entered a 19-week double-blind phase: 6-week titration (2 mg/week increments to target dose) followed by a 13-week maintenance period. Percent change in seizure frequency was the primary endpoint; 50% responder rate was the primary endpoint for EU registration.
منابع مشابه
Adjunctive perampanel for refractory partial-onset seizures: randomized phase III study 304.
OBJECTIVE To assess efficacy and safety of once-daily 8 or 12 mg perampanel, a noncompetitive α-amino-3-hydroxy-5-methyl-4-isoxazole-propionic acid (AMPA) receptor antagonist, when added to concomitant antiepileptic drugs (AEDs) in the treatment of drug-resistant partial-onset seizures. METHODS This was a multicenter, double-blind, placebo-controlled trial (ClinicalTrials.gov identifier: NCT0...
متن کاملClinical experience with adjunctive perampanel in adult patients with uncontrolled epilepsy: A UK and Ireland multicentre study
PURPOSE To derive clinically useful information about the efficacy and tolerability of adjunctive treatment with perampanel for refractory epilepsy in an outpatient setting. METHOD We pooled retrospective casenotes data of adult patients with refractory epilepsy prescribed perampanel from 18 hospitals throughout UK and Ireland. RESULTS Three hundred and ten patients were included (mean age ...
متن کاملImpact of perampanel on pharmacokinetics of concomitant antiepileptics in patients with partial‐onset seizures: pooled analysis of clinical trials
AIMS To evaluate the impact of perampanel and demographics on clearance of concomitant antiepileptic drugs (AEDs), in patients with refractory partial-onset seizures. METHODS Pooled data from three Phase III clinical studies with adjunctive perampanel were used. Blood samples for evaluation of 11 concomitant AEDs were taken during baseline (before perampanel initiation), and at weeks 10, 14, ...
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INTRODUCTION Current pathways for treatment of partial onset epilepsy are diverse and include 14 new antiepileptic drugs (AEDs) licensed for use as either monotherapy or adjunctive therapy. However, the impact of these new AEDs on the treatment of partial epilepsy has so far been disappointing and there persists a need for additional drugs. Recently, perampanel, a first-in-class AED was license...
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