NCT03208660CompletedNot Applicable
A Retrospective Multicenter Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Eisai Inc.
- Enrollment
- 2,000
- Locations
- 44
- Primary Endpoint
- Percentage of participants remaining on Fycompa treatment at specified time points after initiation of treatment (Retention rate)
Study Overview
Brief Summary
This study is conducted to assess the retention rate of Fycompa when given in routine clinical care.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants must have met all of the following criteria to be included in this study:
- •Diagnosis of epilepsy
- •Initiated treatment with Fycompa at any time after 01 Jan 2014
- •Provided written informed consent by the participant or the participant's legally authorized representative signed for the use of medical records (if required by an Institutional Review Board [IRB] or Independent Ethics Committee [IEC], or by regulatory authorities).
Exclusion Criteria
- •Not applicable
Arms & Interventions
Fycompa
Participants diagnosed with epilepsy and treated with Fycompa
Intervention: Fycompa (Drug)
Outcomes
Primary Outcomes
Percentage of participants remaining on Fycompa treatment at specified time points after initiation of treatment (Retention rate)
Time Frame: 3, 6, 12, 18, and 24 months
Retention rate is the ratio of the number of participants remaining on Fycompa treatment to the number of participants who could have been exposed for that length of time.
Secondary Outcomes
- Average dose of Fycompa(Up to 24 months)
- Number of participants with any treatment-emergent adverse event (TEAE) resulting in discontinuation of Fycompa(Up to 24 months)
- Mean change in height of pediatric participants from baseline(Baseline, Up to 24 months)
- Maximum dose of Fycompa(Up to 24 months)
- Number of participants with a 50% response rate(up to 24 months)
- Number of participants with a 75% response rate(up to 24 months)
- Number of participants with a 100% response rate(up to 24 months)
- Categorized percent reduction in seizure frequency from baseline(Baseline, up to 24 months)
- Median percent change in seizure frequency from baseline(Baseline, up to 24 months)
- Percentage of participants who had no change or a worsening of seizures from baseline(Baseline, up to 24 months)
- Mean change in body weight from baseline(Baseline, Up to 24 months)
- Total provider health care visits before, during, and after final dose of Fycompa(6 months before initiation of Fycompa to 6 months after last dose of Fycompa)
- Number of participants with any treatment-emergent (TE) serious adverse event (SAE) resulting in discontinuation of Fycompa(Up to 24 months)
Investigators
Study Sites (44)
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