Adjunctive Perampanel for the Treatment of Drug-Resistant Primary Generalized Tonic-Clonic (PGTC) Seizures in Patients with Idiopathic Generalized Epilepsy (IGE): A Double-Blind, Randomized, Placebo-Controlled Phase III Trial (S31.007)
Bibliographic record
Abstract
OBJECTIVE: To assess the efficacy and safety of adjunctive perampanel for treating drug-resistant PGTC seizures in patients with IGE. BACKGROUND: The AMPA receptor antagonist perampanel is approved in 40 countries for the adjunctive treatment of partial-onset seizures with or without secondary generalization in patients with epilepsy aged 蠅12 years (蠅18 years in Canada). DESIGN/METHODS: Patients (蠅12 years; confirmed IGE; 蠅3 PGTC seizures in 8 weeks prior to randomization; 1-3 concomitant antiepileptic drugs) were recruited from 78 sites in 16 countries. This trial (NCT01393743) had Pre-randomization (4-week screening; 4-8 week Baseline), Randomization (4-week Titration, 13-week Maintenance, 4-week Follow-up), and Extension Phases. Patients were randomized (1:1) under double-blind conditions to placebo or perampanel 2 mg/day, uptitrated in weekly 2-mg increments to 8 mg/day or maximum-tolerated dose. Primary endpoints were percent change in PGTC seizure frequency per 28 days (Titration and Maintenance vs Baseline) and 50[percnt] responder rate (蠅50[percnt] reduction in PGTC seizure frequency during Maintenance vs Baseline). Adverse events (AEs) were recorded. RESULTS: Of 164 randomized patients, 162 comprised the full analysis set (perampanel, n=81; placebo, n=81). Median percent changes in PGTC seizure frequency (-76.5[percnt] vs -38.4[percnt]; P<0.0001), 50[percnt] responder rate (64.2[percnt] vs 39.5[percnt]; P=0.0019), and tonic-clonic seizure-free rate (30.9[percnt] vs 12.3[percnt]) all favored perampanel vs placebo. In the safety set (n=163), treatment-emergent AEs occurred in 82.7[percnt] of perampanel-treated patients (vs placebo, 72.0[percnt]). The AEs most frequently reported with perampanel vs placebo were dizziness (32.1[percnt] vs 6.1[percnt]), fatigue (14.8[percnt] vs 6.1[percnt]), and headache (12.3[percnt] vs 9.8[percnt]). Six perampanel-treated (7.4[percnt]) and seven placebo-treated (8.5[percnt]) patients experienced serious AEs, including two deaths (accidental drowning [perampanel] and sudden unexpected death in epilepsy [placebo]). CONCLUSIONS: Adjunctive perampanel improved control of drug-resistant PGTC seizures in patients aged 蠅12 years with IGE. Perampanel was well tolerated, with safety profile consistent with previous observations. Study Supported by: Eisai Inc
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".