Long‐term safety and efficacy of adjunctive perampanel in pediatric patients (ages 4 to <12 years) with inadequately controlled focal‐onset seizures or generalized tonic–clonic seizures
Bibliographic record
Abstract
OBJECTIVE: Study 311 (NCT02849626) Extension A assessed long-term outcomes of adjunctive perampanel treatment in children (ages 4 to <12 years) with uncontrolled focal-onset seizures (FOS), with/without focal to bilateral tonic-clonic seizures (FBTCS), or generalized tonic-clonic seizures (GTCS). METHODS: Patients completing the 23-week Core Study could enter Extension A (29-week Maintenance and 4-week Follow-up Periods) to receive perampanel at the dose achieved during the Core Study. Dose adjustments were permitted per the investigator's discretion during Extension A. The maximum dose was 12 mg/day for patients enrolled in Japan and without enzyme-inducing anti-seizure medications (EIASMs), or 16 mg/day with EIASM(s). Safety and tolerability were monitored throughout Extension A. Efficacy assessments included median percent change in seizure frequency per 28 days from baseline and 50% responder rates. Outcomes were analyzed by seizure type, age (4 to <7 vs 7 to <12 years), and EIASM use. RESULTS: Of 180 patients enrolling in the Core Study, 136 entered (FOS, n = 116 [including 43 with FBTCS]; GTCS, n = 20) and 122 completed Extension A. Treatment-emergent adverse events (TEAEs) were the most common reason for discontinuation (4%). The mean (standard deviation) dose during Extension A was 8.3 (3.2) mg/day. Incidences of TEAEs in Extension A were 69% overall and 62%-89% across subgroups; TEAEs led to dose adjustment in 10% of patients. No changes of clinical concern in cognition, growth, development, or quality of life were identified over 52 weeks. At Weeks 40-52, median percent reductions in seizure frequency per 28 days from baseline were 69% (FOS, n = 108), 74% (FBTCS, n = 41), and 100% (GTCS, n = 13); 50% responder rates were 62% (FOS and GTCS) and 81% (FBTCS). Efficacy outcomes were comparable across age and EIASM groups. SIGNIFICANCE: These findings support long-term (≤52 weeks) use of adjunctive perampanel in children with epilepsy, irrespective of seizure type, age, or EIASM use.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
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".