ArticleEpilepsia open2020
Efficacy and safety of perampanel monotherapy in patients with focal-onset seizures with newly diagnosed epilepsy or recurrence of epilepsy after a period of remission: The open-label Study 342 (FREEDOM Study).
Article in Epilepsia open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03201900 (A Multicenter, Uncontrolled, Open-label Study and Extension Study for Verification of Eefficacy and Safety for Perampanel Monotherapy in Untreated Patients With Partial Onset Seizures), which is not on this map. Cited by 26 papers, 1 of them a synthesis 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 Multicenter, Uncontrolled, Open-label Study and Extension Study for Verification of Eefficacy and Safety for Perampanel Monotherapy in Untreated Patients With Partial Onset Seizures (Including Secondarily Generalized Seizures) (FREEDOM Study)
Who cites it
26 citing papers in PubMed, 1 synthesis or guideline pooled it, 45 citations in OpenAlex.
- Efficacy and tolerability of perampanel in patients with seizures in real-world clinical practice: A systematic review and meta-analysis.Frontiers in pharmacology · 2023Pooled it
- Efficacy and safety of perampanel in patients with seizures associated with Lennox-Gastaut syndrome: A randomized trial.Epilepsia · 2025Trial
- Perampanel as monotherapy or first adjunctive therapy in pediatric and adult patients with epilepsy: the first United States-based phase IV open-label ELEVATE study.Journal of neurology · 2024Trial
- 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
- Effectiveness of low-dose perampanel in focal epilepsy patients aged twelve or older in Southern China: an observational study.Scientific reports · 2026Observational
- Observational
- Efficacy and safety of perampanel as the first medication for children with newly diagnosed epilepsy: a real-world single-center prospective observational study.Frontiers in pediatrics · 2026Article
- Effect of perampanel in reducing depression in patients with focal epilepsy.IBRO neuroscience reports · 2025Article
- Cost-effectiveness of therapeutic drug monitoring of perampanel for pediatrics with epilepsy: real-world data.Frontiers in pharmacology · 2025Article
- Clinical efficacy and safety of perampanel monotherapy as primary anti-seizure medication in the treatment of pediatric epilepsy: A single-center, prospective, observational study.Epilepsia open · 2024Observational
- Impact of Perampanel for First-Episode Seizures versus Usual Care on Clinical Outcome and Safety Profile Aspects of the Thai Experience.Journal of epilepsy research · 2024Article
- Investigating the Effects of Perampanel on Autophagy-mediated Regulation of GluA2 and PSD95 in Epilepsy.Molecular neurobiology · 2024Article
- Serum perampanel levels in patients with seizures are not affected by hemodialysis.Epilepsia open · 2024Article
- Effectiveness and safety of mono- and add-on perampanel in pediatric patients with epilepsy: Experience from a single-center retrospective study.Epilepsia open · 2024Observational
- Efficacy and safety of perampanel monotherapy in Chinese patients with focal-onset seizures: A single-center, prospective, real-world observational study.Epilepsia open · 2023Observational
- Five-Year Retention of Perampanel and Polytherapy Patterns: 328 Patients From a Single Center in South Korea.Journal of clinical neurology (Seoul, Korea) · 2023Article
- Article
- Comparison of the effectiveness and safety of perampanel and oxcarbazepine as monotherapy in children and adolescents with newly diagnosed focal epilepsy.Frontiers in pharmacology · 2023Article
- Effectiveness and tolerability of perampanel monotherapy in children with newly diagnosed focal epilepsy.Frontiers in neurology · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 10 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveOur study assessed perampanel monotherapy in patients (aged ≥12 years) with focal-onset seizures (FOS) with or without focal to bilateral tonic-clonic seizures (FBTCS) in Japan and South Korea.
methodsStudy 342 (NCT03201900; FREEDOM) is a single-arm, open-label, Phase III study. Patients initially received perampanel in a 32-week 4-mg/d Treatment Phase (6-week Titration; 26-week Maintenance Periods). If they experienced a seizure during the 4-mg/d Maintenance Period, they could be up-titrated to 8 mg/d across an additional 30-week Treatment Phase (4-week Titration; 26-week Maintenance Periods). Primary endpoint was the seizure-freedom rate during the Maintenance Period (4 mg/d and last evaluated dose [4 or 8 mg/d]). Secondary endpoints included time to first seizure onset and to withdrawal during Maintenance. Treatment-emergent adverse events (TEAEs) were monitored.
resultsAt data cutoff (February 28, 2019), 89 patients with FOS (84 [94.4%] with newly diagnosed epilepsy and 5 [5.6%] with recurrence of epilepsy after a period of remission) had received ≥1 perampanel dose; 16 patients discontinued during the 4-mg/d Titration Period, meaning 73 patients entered the 4-mg/d Maintenance Period and were included in the primary analysis set for efficacy. Seizure-freedom rate in the 26-week Maintenance Period was 46/73 (63.0%; 95% confidence interval [CI]: 50.9-74.0) at 4 mg/d and 54/73 (74.0%; 95% CI: 62.4-83.5) at 4 or 8 mg/d. Cumulative probability of seizure-onset and withdrawal rates during Maintenance was 30.8% (95% CI: 21.5-43.0) and 23.7% (95% CI: 15.4-35.3) at 4 mg/d, and 18.2% (95% CI: 11.0-29.3) and 23.3% (95% CI: 15.2-34.8) at 4 or 8 mg/d. Perampanel was generally well tolerated, and the most common TEAE was dizziness. SIGNIFICANCE: Perampanel monotherapy (4 to 8 mg/d) was efficacious and consistent with the known safety profile up to 26 weeks in patients (≥12 years) with primarily newly diagnosed FOS with or without FBTCS.
Indexed as
Identifiers
What OpenQuestion holds
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.