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

NCT04202159 | Completed FDA Drug

• 1 other identifier: E2007-M049-509
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 34

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.

Conditions

Seizures

Keywords

E2007; Perampanel; Fycompa; Primary generalized tonic-clonic seizures; Secondarily generalized tonic-clonic seizures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percentage of Participants Remaining on Perampanel at Month 6 (Retention Rate)

  Month 6

• Percentage of Participants Who Achieved Seizure Freedom for All Generalized Tonic-clonic (GTC) Seizures at Month 12

  Month 12

• 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

Study Arms (1)

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).

Drug: Perampanel

Interventions

Perampanel DRUG

Perampanel tablets.

Also known as: E2007, Fycompa

Perampanel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with PGTC or SGTC seizures.

You may qualify if:

• Confirmed diagnosis of epilepsy with PGTC or SGTC seizures based on focal or idiopathic generalized epilepsy
• The decision to prescribe perampanel was made by the physician before and irrespective of his/her decision to include the participant in the study
• Receiving treatment with perampanel in line with the current Fycompa (perampanel) SmPC

You may not qualify if:

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

Sponsors & Collaborators

• Eisai GmbH: lead

Study Sites (34)

Eisai Trial Site #51

Aalen, Germany

Location

Eisai Trial Site #12

Berlin, Germany

Location

Eisai Trial Site #43

Berlin, Germany

Location

Eisai Trial Site #15

Bernau, Germany

Location

Eisai Trial Site #8

Bielefeld, Germany

Location

Eisai Trial Site #53

Bochum, Germany

Location

Eisai Trial Site #38

Bonn, Germany

Location

Eisai Trial Site #9

Bonn, Germany

Location

Eisai Trial Site #25

Damp, Germany

Location

Eisai Trial Site #48

Dortmund, Germany

Location

Eisai Trial Site #27

Dresden, Germany

Location

Eisai Trial Site #50

Dresden, Germany

Location

Eisai Trial Site #7

Erlangen, Germany

Location

Eisai Trial Site #44

Friedrichshafen, Germany

Location

Eisai Trial Site #4

Greifswald, Germany

Location

Eisai Trial Site #21

Hamburg, Germany

Location

Eisai Trial Site #47

Hamburg, Germany

Location

Eisai Trial Site #14

Jena, Germany

Location

Eisai Trial Site #18

Kiel, Germany

Location

Eisai Trial Site #54

Kiel, Germany

Location

Eisai Trial Site #1

Kork, Germany

Location

Eisai Trial Site #24

Leipzig, Germany

Location

Eisai Trial Site #28

Lübeck, Germany

Location

Eisai Trial Site #26

Magdeburg, Germany

Location

Eisai Trial Site #13

Mainz, Germany

Location

Eisai Trial Site #36

Mittweida, Germany

Location

Eisai Trial Site #42

Nierstein, Germany

Location

Eisai Trial Site #2

Radeberg, Germany

Location

Eisai Trial Site #16

Ravensburg, Germany

Location

Eisai Trial Site #23

Regensburg, Germany

Location

Eisai Trial Site #46

Remscheid, Germany

Location

Eisai Trial Site #3

Tübingen, Germany

Location

Eisai Trial Site #37

Ulm, Germany

Location

Eisai Trial Site #40

Weil der Stadt, Germany

Location

MeSH Terms

Conditions

Seizures

Interventions

perampanel

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 17, 2019
• Study Start: January 21, 2020
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share

Locations

DE (34)