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Clinical Trials/NCT03059329
NCT03059329
Completed
Not Applicable

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

Eisai Co., Ltd.0 sites3,809 target enrollmentAugust 1, 2016

Overview

Phase
Not Applicable
Intervention
Fycompa
Conditions
Partial Seizures (With or Without Secondary Generalized Seizures)
Sponsor
Eisai Co., Ltd.
Enrollment
3809
Primary Endpoint
Number of participants with any serious adverse event
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The objective of this study is to identify the following in adult 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).
Registry
clinicaltrials.gov
Start Date
August 1, 2016
End Date
September 13, 2019
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Epilepsy participants at least 18 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

Adult 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 52 weeks

Number of participants with any non-serious adverse event

Time Frame: from 0 to 52 weeks

Secondary Outcomes

  • Number of participants experiencing seizures(from 0 to 52 weeks)
  • Overall improvement rating in seizure frequency(from 0 to 52 weeks)

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