Trial reportNeurology2015
Perampanel for tonic-clonic seizures in idiopathic generalized epilepsy A randomized trial.
Trial report in Neurology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01393743 (A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Adjunctive Perampanel in Primary Generalized Tonic Clonic Seizures), which is not on this map. Cited by 139 papers, 6 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Adjunctive Perampanel in Primary Generalized Tonic Clonic Seizures
Who cites it
139 citing papers in PubMed, 6 syntheses or guidelines pooled it, 326 citations in OpenAlex.
- Pooled it
- Perampanel add-on for drug-resistant focal epilepsy.The Cochrane database of systematic reviews · 2023Pooled it
- Impact of Antiseizure Medications on Appetite and Weight in Children.Paediatric drugs · 2022Pooled it
- Exploring the Evidence for Broad-Spectrum Effectiveness of Perampanel: A Systematic Review of Clinical Data in Generalised Seizures.CNS drugs · 2021Pooled it
- Perampanel Improves Cortical Myoclonus and Disability in Progressive Myoclonic Epilepsies: A Case Series and a Systematic Review of the Literature.Frontiers in neurology · 2021Pooled it
- Meta-analysis of drug efficacy in adult vs pediatric trials of patients with PGTC seizures.Neurology · 2020Pooled it
- A first in disease trial of the safety, tolerability, and anti-seizure effects of ES-481 in drug-resistant epilepsy.Epilepsia open · 2026Trial
- Bioequivalence of Two Perampanel Oral Suspension Formulations in Healthy Subjects: A Randomized Crossover Study.Drugs in R&D · 2025Trial
- Trial
- Efficacy and safety of perampanel in patients with seizures associated with Lennox-Gastaut syndrome: A randomized trial.Epilepsia · 2025Trial
- Trial
- Efficacy and Safety of adjunctive Perampanel in a prospective, real-world, Phase IV study in Indian patients aged ≥12 years for Treatment of focal-onset Epilepsy: Study 508.Epilepsia open · 2024Trial
- Trial
- Long-term open-label perampanel: Generalized tonic-clonic seizures in idiopathic generalized epilepsy.Epilepsia open · 2022Trial
- Intravenous Perampanel as an Interchangeable Alternative to Oral Perampanel: A Randomized, Crossover, Phase I Pharmacokinetic and Safety Study.Clinical pharmacology in drug development · 2022Trial
- PROVE: Retrospective, non-interventional, Phase IV study of perampanel in real-world clinical care of patients with epilepsy.Epilepsia open · 2022Trial
- Efficacy, safety, and tolerability of adjunctive perampanel in patients from China with focal seizures or generalized tonic-clonic seizures: Post hoc analysis of phase III double-blind and open-label extension studies.CNS neuroscience & therapeutics · 2021Trial
- Trial
- Perampanel in real-world clinical care of patients with epilepsy: Interim analysis of a phase IV study.Epilepsia open · 2021Trial
- Bioequivalence of perampanel fine granules and tablets in healthy Japanese subjects.International journal of clinical pharmacology and therapeutics · 2020Trial
79 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 6 institutions in 4 countries.
Funding
Abstract
objectiveTo assess efficacy and safety of adjunctive perampanel in patients with drug-resistant, primary generalized tonic-clonic (PGTC) seizures in idiopathic generalized epilepsy (IGE).
methodsIn this multicenter, double-blind study (ClinicalTrials.gov identifier: NCT01393743; funded by Eisai Inc.), patients 12 years or older with PGTC seizures and IGE were randomized to placebo or perampanel during a 4-week titration period (perampanel up titrated from 2 to 8 mg/d, or highest tolerated dose) and 13-week maintenance period. The primary endpoint was percent change in PGTC seizure frequency per 28 days (titration plus maintenance vs baseline). The key secondary endpoint (primary endpoint for European Union registration) was 50% PGTC seizure responder rate (patients achieving $50% reduction in PGTC seizure frequency; maintenance vs baseline). Treatment-emergent adverse events were monitored.
resultsOf 164 randomized patients, 162 comprised the full analysis set (placebo, 81; perampanel, 81). Compared with placebo, perampanel conferred a greater median percent change in PGTC seizure frequency per 28 days (238.4%vs 276.5%; p , 0.0001) and greater 50%PGTC seizure responder rate (39.5% vs 64.2%; p 5 0.0019). During maintenance, 12.3% of placebo treated patients and 30.9%of perampanel-treated patients achieved PGTC seizure freedom. For the safety analysis (placebo, 82; perampanel, 81), the most frequent treatment-emergent adverse events with perampanel were dizziness (32.1%) and fatigue (14.8%).
conclusionsAdjunctive perampanel was well tolerated and improved control of drug-resistant PGTC seizures in patients with IGE. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that adjunctive perampanel reduces PGTC seizure frequency, compared with placebo, in patients with drug-resistant PGTC seizures in IGE.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.