Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adolescence Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures

Completed

• Conditions: Partial Seizures (With or Without Secondary Generalized Seizures); Primary Generalized Tonic-clonic Seizures
• Interventions: Drug: Fycompa

• Registration Number: NCT03059381
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

The objective of this study is to identify the following in adolescent epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa:

1. unknown adverse drug reactions (ADRs);

2. occurrence of ADRs;

3. factors that are likely to affect safety and efficacy;

4. occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse events, and falls as priority investigation items;

5. occurrence of psychiatric adverse events as priority investigation items (eg, aggression).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-01
• Study First Submitted: 2017-02-17
• Study First Submitted QC: 2017-02-20
• Study First Posted: 2017-02-23
• Primary Completion: 2021-03-21
• Study Completion: 2021-03-21
• Status Verified: 2021-04
• Last Update Submitted: 2022-08-03
• Last Update Posted: 2022-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 519

Inclusion Criteria

• Epilepsy participants from 12 to 17 years of age with:

  • Partial seizures (with or without secondary generalized seizures)
  • Primary generalized Tonic-clonic seizures

Exclusion Criteria

• Participants previously treated with Fycompa

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fycompa-treated epilepsy participants	Fycompa	Adolescent epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa

Primary Outcome Measures

Name	Time	Method
Number of participants with any serious adverse event	from 0 to 104 weeks
Number of participants with any non-serious adverse event	from 0 to 104 weeks

Secondary Outcome Measures

Name	Time	Method
Number of participants experiencing seizures	from 0 to 104 weeks
Overall improvement rating in seizure frequency	from 0 to 104 weeks