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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04202159
Other study ID # E2007-M049-509
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 21, 2020
Est. completion date March 31, 2023

Study information

Verified date August 2023
Source Eisai Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 187
Est. completion date March 31, 2023
Est. primary completion date March 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Perampanel
Perampanel tablets.
Perampanel
Perampanel oral suspension.

Locations

Country Name City State
Germany Eisai Trial Site #51 Aalen
Germany Eisai Trial Site #12 Berlin
Germany Eisai Trial Site #43 Berlin
Germany Eisai Trial Site #15 Bernau
Germany Eisai Trial Site #8 Bielefeld
Germany Eisai Trial Site #53 Bochum
Germany Eisai Trial Site #38 Bonn
Germany Eisai Trial Site #9 Bonn
Germany Eisai Trial Site #25 Damp
Germany Eisai Trial Site #48 Dortmund
Germany Eisai Trial Site #27 Dresden
Germany Eisai Trial Site #50 Dresden
Germany Eisai Trial Site #7 Erlangen
Germany Eisai Trial Site #44 Friedrichshafen
Germany Eisai Trial Site #4 Greifswald
Germany Eisai Trial Site #21 Hamburg
Germany Eisai Trial Site #47 Hamburg
Germany Eisai Trial Site #14 Jena
Germany Eisai Trial Site #18 Kiel
Germany Eisai Trial Site #54 Kiel
Germany Eisai Trial Site #1 Kork
Germany Eisai Trial Site #24 Leipzig
Germany Eisai Trial Site #28 Lübeck
Germany Eisai Trial Site #26 Magdeburg
Germany Eisai Trial Site #13 Mainz
Germany Eisai Trial Site #36 Mittweida
Germany Eisai Trial Site #42 Nierstein
Germany Eisai Trial Site #2 Radeberg
Germany Eisai Trial Site #16 Ravensburg
Germany Eisai Trial Site #23 Regensburg
Germany Eisai Trial Site #46 Remscheid
Germany Eisai Trial Site #3 Tübingen
Germany Eisai Trial Site #37 Ulm
Germany Eisai Trial Site #40 Weil der Stadt

Sponsors (1)

Lead Sponsor Collaborator
Eisai GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants Remaining on Perampanel at Month 12 (Retention Rate) The retention rate is defined as the percentage of participants remaining on perampanel treatment at 12 months after the initiation of treatment. Month 12
Secondary Percentage of Participants Remaining on Perampanel at Month 6 (Retention Rate) The retention rate is defined as the percentage of participants remaining on perampanel treatment at 6 months after the initiation of treatment. Month 6
Secondary Percentage of Participants Who Achieved Seizure Freedom for All Generalized Tonic-clonic (GTC) Seizures at Month 12 Month 12
Secondary Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Treatment-emergent Serious Adverse Events (SAE), and Adverse Events (AEs) by Severity 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). Up to Month 12
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