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NCT04252846

A Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Add-on Therapy in Participants >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy

Completed Last updated 9 February 2023
What this trial tests

trial testing Perampanel in Idiopathic Generalized Epilepsy in 191 participants. Completed in 12 January 2023.

Timeline
20 July 2020
Primary endpoint
12 January 2023
12 January 2023

Quick facts

Lead sponsorEisai Limited
StatusCompleted
Study typeOBSERVATIONAL
Enrollment191
Start date20 July 2020
Primary completion12 January 2023
Estimated completion12 January 2023
Sites36 locations across Denmark, France, Italy, Russia, Germany, Portugal, Spain

Drugs / interventions tested

Conditions studied

Sponsor

Eisai Limited — full company profile →

Who can join

12 and older, any sex, with Idiopathic Generalized Epilepsy or Partial Onset Seizures. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary purpose of this study is to assess the retention rate of perampanel as a reliable proxy for overall effectiveness and tolerability in participants aged at least 12 years who are prescribed perampanel (for partial onset seizures \[POS\] with or without secondary generalization \[SG\] or for primary generalized tonic-clonic seizures \[PGTCS\] associated with idiopathic generalized epilepsy \[IGE\] as first adjunctive to antiepileptic drug (AED) monotherapy as part of their routine clinical care.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A Phase 4, multicenter, prospective, non-interventional, observational study to investigate the effectiveness and safety/tolerability of perampanel when used as first adjunctive therapy in routine clinical practice in people with epilepsy: Study 512.
    Burd S, Assenza G, Quintas S, Gil López FJ, et al · · 2025 · PMID 40303887 · DOI 10.3389/fneur.2025.1533767

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Other trials of Perampanel

Trials testing the same drug.

Other Eisai Limited trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04252846.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing