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
Overview
- Phase
- Not Applicable
- Intervention
- Fycompa
- Conditions
- Partial Seizures (With or Without Secondary Generalized Seizures)
- Sponsor
- Eisai Co., Ltd.
- Enrollment
- 519
- Primary Endpoint
- Number of participants with any serious adverse event
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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:
- unknown adverse drug reactions (ADRs);
- occurrence of ADRs;
- factors that are likely to affect safety and efficacy;
- occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse events, and falls as priority investigation items;
- occurrence of psychiatric adverse events as priority investigation items (eg, aggression).
Investigators
Eligibility Criteria
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
Arms & Interventions
Fycompa-treated epilepsy participants
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
Intervention: Fycompa
Outcomes
Primary Outcomes
Number of participants with any serious adverse event
Time Frame: from 0 to 104 weeks
Number of participants with any non-serious adverse event
Time Frame: from 0 to 104 weeks
Secondary Outcomes
- Number of participants experiencing seizures(from 0 to 104 weeks)
- Overall improvement rating in seizure frequency(from 0 to 104 weeks)