Trials / Completed
CompletedNCT04252846
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
A Prospective, Non-Interventional, Observational, Multicenter Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Adjunctive Therapy in the Routine Clinical Care of Subjects >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 191 (actual)
- Sponsor
- Eisai Limited · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Perampanel | Perampanel oral tablets or oral suspension. |
Timeline
- Start date
- 2020-07-20
- Primary completion
- 2023-01-12
- Completion
- 2023-01-12
- First posted
- 2020-02-05
- Last updated
- 2023-02-09
Locations
36 sites across 7 countries: Denmark, France, Germany, Italy, Portugal, Russia, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04252846. Inclusion in this directory is not an endorsement.