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AMPA Receptor Antagonist

Fycompa for Small Fiber Neuropathy

Phase 2
Waitlist Available
Led By Todd Levine, MD
Research Sponsored by PNA Center for Neurological Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

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.

Eligible Conditions
  • Small Fiber Neuropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2014 Phase 4 trial • 24 Patients • NCT01507181
58%
Headache
33%
Hospitalizations
17%
Poor concentration
17%
Anxiety
17%
Poor coordination
17%
General malaise
17%
Restlessness
17%
Dizziness on standing
8%
Blurred vision
8%
Difficulty sleeping
8%
Nausea/Vomiting
8%
Constipation
8%
Death
8%
Frequent urination
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine
Midazolam

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: FycompaExperimental Treatment1 Intervention
Fycompa dose is chosen based on tolerability and efficacy. 2mg to 8mg daily for 6 weeks then washed out.
Group II: PlaceboPlacebo Group1 Intervention
Inactive ingredient equal to 2mg tablets
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Perampanel
FDA approved

Find a Location

Who is running the clinical trial?

Eisai Inc.Industry Sponsor
518 Previous Clinical Trials
159,307 Total Patients Enrolled
PNA Center for Neurological ResearchLead Sponsor
Todd Levine, MDPrincipal InvestigatorPNA Center for Neurological Research
2 Previous Clinical Trials
508 Total Patients Enrolled
~3 spots leftby Sep 2025
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