A Study of Perampanel as Add-on Therapy in Adult and Adolescent Participants With Focal Seizures

NCT ID: NCT04257604

Last Updated: 2020-02-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 243 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-03
• Study Completion Date: 2019-04-30

Brief Summary

The primary objective of the present study will be to assess the effectiveness of add-on perampanel in participants with focal seizures in a real-life clinical setting.

Conditions

Partial Seizures

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Perampanel

Participants with partial-onset seizures, with or without secondary generalization will receive perampanel tablets as add-on therapy according to the approved summary of product characteristics (SmPC) after the baseline visit as part of the clinical practice and will be observed after 3 months (visit 1), 6 months (visit 2), and 12 months (final visit).

Perampanel

Intervention Type: DRUG

Perampanel tablets.

Interventions

Perampanel

Perampanel tablets.

Intervention Type: DRUG

Other Intervention Names

Fycompa; E2007

Eligibility Criteria

Inclusion Criteria

1. Prescribe perampanel according to the approved indication

2. Participants with focal seizures with or without secondary generalization

3. Participants with seizure frequency data available at the baseline visit

4. Based on the physician's clinical judgment, the participant seizure activity is not controlled sufficiently with the current treatment with 1-3 AEDs and it is in the participants best interest to be prescribed adjunctive perampanel

5. The decision to prescribe perampanel is made by the physician before and independently of his/her decision to include the participant in the study

6. Treatment with perampanel is not yet started before baseline

Exclusion Criteria

1. Participants contraindicated for perampanel use (according to SmPC)

2. Participants with moderate to severe renal impairment

3. Participants with severe hepatic impairment

4. Pregnant or lactating women

5. Participants suffering from clinically significant psychiatric illness, psychological or behavioral problems which could interfere with study participation

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

E2007-M044-501

Identifier Type: -

Identifier Source: org_study_id