Fycompa in Subjects With Small Fiber Neuropathy (SFN)
NCT02511873 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2016-01-27
Summary
This is a Phase II, 2 arm randomized crossover study. Subjects will be assigned to either active agent or placebo and then crossover to the other arm. This study is designed to evaluate whether Fycompa improves the quality of life in patients with small fiber neuropathy.
Conditions
- Neuropathy, Small Fiber
Interventions
- DRUG
-
Fycompa
Subjects will take Fycompa for 6 weeks with a dose range of 2mg to 8mg daily
- DRUG
-
Placebo (looks like study drug but has no active ingredients) for 6 weeks with a dose range of 2mg to 8mg daily
Sponsors & Collaborators
-
Eisai Inc.
collaborator INDUSTRY -
PNA Center for Neurological Research
lead OTHER
Principal Investigators
-
Todd Levine, MD · PNA Center for Neurological Research
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-31
- Primary Completion
- 2016-12-31
- Completion
- 2016-12-31
Countries
- United States
Study Locations
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