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Clinical Trials/NCT03059381
NCT03059381CompletedNot Applicable

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

Eisai Co., Ltd.0 sites519 target enrollmentStarted: August 1, 2016Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
519
Primary Endpoint
Number of participants with any serious adverse event

Study 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:

  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).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
12 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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 (Drug)

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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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