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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
Small Fiber Neuropathy(SFN) proven by skin biopsy assessment of intraepidermal nerve fiber density.
Pain scores of at least a 5 on a VAS scale.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 5, week 12 and week 18
Awards & highlights
Study 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
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 5, week 12 and week 18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 5, week 12 and week 18
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To Assess the Change of Pain Symptoms Upon Treatment of Fycompa in Comparison to Placebo using Visual Analog Scale (VAS) andBrief Pain inventory(BPI) Short Form
Secondary outcome measures
Pharmaceutical Preparations
Side effects data
From 2014 Phase 4 trial • 24 Patients • NCT0150718158%
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
515 Previous Clinical Trials
154,069 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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