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

Seizures Clinical Trial

Official title:

PERPRISE: A Prospective Non-interventional Study Evaluating the Effectiveness of Perampanel (Fycompa®) as Only Add-on Treatment in Patients With Primary or Secondarily Generalized Tonic-clonic Seizures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04202159
• Other study ID #: E2007-M049-509
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Seizures

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