A Study to Evaluate the Effectiveness of Perampanel as Only Add-on Treatment in Participants With Primary or Secondarily Generalized Tonic-clonic Seizures

Completed

• Conditions: Seizures
• Interventions: Drug: Perampanel

• Registration Number: NCT04202159
• Lead Sponsor: Eisai GmbH

Brief Summary

The primary purpose of this study is to investigate the effectiveness reflected by the retention rate of perampanel as the only add-on treatment in adult participants with primary generalized tonic-clonic (PGTC) or secondarily generalized tonic-clonic (SGTC) seizures based on focal or idiopathic generalized epilepsy in a non-interventional (observational) setting.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-16
• Study First Submitted QC: 2019-12-16
• Study First Posted: 2019-12-17
• Study Start: 2020-01-21
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-02
• Last Update Posted: 2023-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

Inclusion Criteria

1. Confirmed diagnosis of epilepsy with PGTC or SGTC seizures based on focal or idiopathic generalized epilepsy
2. Active epilepsy with GTC seizures, demonstrated by the occurrence of at least 1 GTC seizure within 3 months before inclusion
3. The decision to prescribe perampanel was made by the physician before and irrespective of his/her decision to include the participant in the study
4. Receiving treatment with perampanel in line with the current Fycompa (perampanel) SmPC
5. Perampanel must either be newly administered as the only add-on treatment to a current antiepileptic drug (AED) monotherapy or must be planned to substitute one of two AEDs of a current dual therapy planned to be stopped within 2 months after initiation of treatment with perampanel. It will be specified which AED is planned to be substituted by perampanel upon inclusion. It is assumed that participants start treatment with perampanel closely after the baseline visit. Retrospective inclusions will be allowed, but only if the time between the initiation of perampanel treatment and inclusion does not exceed 7 calendar days. In this case, the baseline visit documentation should reflect the situation (including seizure situation 3 months before baseline and baseline medication) to the date perampanel treatment was initiated

Exclusion Criteria

1. Participants with known psychogenic non-epileptic seizures
2. The participant had already received perampanel in the past
3. Simultaneous participation in an interventional clinical study and/or taking an investigational drug

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Perampanel	Perampanel	Participants with PGTC or SGTC seizures may receive perampanel tablets or oral suspension as only add-on therapy based on physicians decision in accordance with summary of product characteristics (SmPC) and will be observed at baseline, 6 months (intermediate visit), and 12 months (final visit).

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Remaining on Perampanel at Month 12 (Retention Rate)	Month 12	The retention rate is defined as the percentage of participants remaining on perampanel treatment at 12 months after the initiation of treatment.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Remaining on Perampanel at Month 6 (Retention Rate)	Month 6	The retention rate is defined as the percentage of participants remaining on perampanel treatment at 6 months after the initiation of treatment.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Treatment-emergent Serious Adverse Events (SAE), and Adverse Events (AEs) by Severity	Up to Month 12	AEs will be graded on a 3-point scale that is mild (discomfort noticed, but no disruption of normal daily activity), moderate (discomfort sufficient to reduce or affect normal daily activity), and severe (incapacitating, with inability to work or to perform normal daily activity).
Percentage of Participants Who Achieved Seizure Freedom for All Generalized Tonic-clonic (GTC) Seizures at Month 12	Month 12

Trial Locations

Locations (34)

Eisai Trial Site #15; 🇩🇪 Bernau, Germany

Eisai Trial Site #8; 🇩🇪 Bielefeld, Germany

Eisai Trial Site #9; 🇩🇪 Bonn, Germany

Eisai Trial Site #23; 🇩🇪 Regensburg, Germany

Eisai Trial Site #46; 🇩🇪 Remscheid, Germany

Eisai Trial Site #12; 🇩🇪 Berlin, Germany

Eisai Trial Site #51; 🇩🇪 Aalen, Germany

Eisai Trial Site #21; 🇩🇪 Hamburg, Germany

Eisai Trial Site #53; 🇩🇪 Bochum, Germany

Eisai Trial Site #25; 🇩🇪 Damp, Germany

Eisai Trial Site #48; 🇩🇪 Dortmund, Germany

Eisai Trial Site #43; 🇩🇪 Berlin, Germany

Eisai Trial Site #50; 🇩🇪 Dresden, Germany

Eisai Trial Site #47; 🇩🇪 Hamburg, Germany

Eisai Trial Site #27; 🇩🇪 Dresden, Germany

Eisai Trial Site #38; 🇩🇪 Bonn, Germany

Eisai Trial Site #44; 🇩🇪 Friedrichshafen, Germany

Eisai Trial Site #7; 🇩🇪 Erlangen, Germany

Eisai Trial Site #4; 🇩🇪 Greifswald, Germany

Eisai Trial Site #54; 🇩🇪 Kiel, Germany

Eisai Trial Site #26; 🇩🇪 Magdeburg, Germany

Eisai Trial Site #1; 🇩🇪 Kork, Germany

Eisai Trial Site #24; 🇩🇪 Leipzig, Germany

Eisai Trial Site #13; 🇩🇪 Mainz, Germany

Eisai Trial Site #42; 🇩🇪 Nierstein, Germany

Eisai Trial Site #36; 🇩🇪 Mittweida, Germany

Eisai Trial Site #2; 🇩🇪 Radeberg, Germany

Eisai Trial Site #16; 🇩🇪 Ravensburg, Germany

Eisai Trial Site #3; 🇩🇪 Tübingen, Germany

Eisai Trial Site #37; 🇩🇪 Ulm, Germany

Eisai Trial Site #40; 🇩🇪 Weil der Stadt, Germany

Eisai Trial Site #14; 🇩🇪 Jena, Germany

Eisai Trial Site #18; 🇩🇪 Kiel, Germany

Eisai Trial Site #28; 🇩🇪 Lübeck, Germany