Fycompa in Subjects With Small Fiber Neuropathy (SFN)

Randomized Crossover Trial of Fycompa in the Treatment of Pain Associated With Small Fiber Neuropathy (SFN)

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.

Study Overview

• Status: Unknown
• Conditions: Neuropathy, Small Fiber
• Intervention / Treatment: Drug: Fycompa; Drug: Placebo

Detailed Description

This study will enroll 30 patients from our center alone with a proven SFN diagnosis by a skin biopsy assessment of intraepidermal nerve fiber density. The patients must also have a pain score of a least 5 on a VAS Scale. Patients will receive Fycompa 2mg tablets. Each week patients will be allowed to titrate up by 2mgs up to a maximum dose of 8mg a day. This dosing has been used in numerous pain studies when no single dose has been proven to be effective. This does not seem to reduce the validity of the placebo phase. Patients can choose the dose they feel is best tolerated and most efficacious. Once patients choose this dose they will be randomized into two arms. Each arm will last 6 weeks. Such that patient will receive the dose they chose as most efficacious for 6 weeks or matching placebo for 6 weeks. Then each patient will crossover to the other arm. Investigator will assess compliance by counting pills at each visit. This will provide the ability to see which dose most patients prefer and then study the dose in a blinded randomized fashion. There will be 5 office visits and 3 phone visits in the study and . Patients will keep a diary of weekly VAS pain scores.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • PNA Center for Neurological Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Small Fiber Neuropathy(SFN) proven by skin biopsy assessment of intraepidermal nerve fiber density.
2. Pain scores of at least a 5 on a VAS scale.
3. Male or Female 18 to 60 years old.
4. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
5. Stable dose of current pain medication or any medication used for SFN 60 days prior to screening.
6. Women of reproductive age must agree to use double-barrier method of contraception.

Exclusion Criteria:

1. History of intolerance or hypersensitivity to Fycompa.
2. History of psychosis, drug or alcohol abuse within the last 2 years.
3. Malignancy within the last 2 years (except skin cancer).
4. Clinically significant condition (including but not limited to cardiovascular or hepatic diseases and seizure disorders).
5. Pregnant females, breastfeeding females, females of childbearing potential not using effective contraception.
6. Subjects with other severe pain conditions which may impair the self-assessment of pain due to SFN.
7. Exclusion medications for this study: Carbamazepine, Carbatrol, Tegretol, Tegretol XR, Equetro, Epitol, Phenytoin, Dilantin, Phenytek, Oxcarbazepine, Trileptal, Rifampin, Refadin, Rimactane and St. John Wort.
8. Subjects with renal impairment or on hemodialysis or who have hepatic impairment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fycompa; Fycompa dose is chosen based on tolerability and efficacy. 2mg to 8mg daily for 6 weeks then washed out.	Drug: Fycompa; Subjects will take Fycompa for 6 weeks with a dose range of 2mg to 8mg daily; Other Names: Perampanel; E2007; AMPA - type Glutamate Receptor Antagonist
Placebo Comparator: Placebo; Inactive ingredient equal to 2mg tablets	Drug: Placebo; Placebo (looks like study drug but has no active ingredients) for 6 weeks with a dose range of 2mg to 8mg daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Baseline, Week 5, Week 12 and Week 18

Secondary Outcome Measures

Outcome Measure	Time Frame
To Assess improvement of Quality of Life Upon Treatment of Fycompa in Comparison to Placebo using Neuro QOL Lower Extremity Function Scale, Patient Global impression of Change (PGIC) Scale and Treatment Satisfaction Questionnaire for Medication (TSQM)	Baseline, Week 5, Week 12 and Week 18

Collaborators and Investigators

• Sponsor: PNA Center for Neurological Research
• Collaborators: Eisai Inc.
• Investigators: Principal Investigator: Todd Levine, MD, PNA Center for Neurological Research

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: July 23, 2015
• First Submitted That Met QC Criteria: July 27, 2015
• First Posted (Estimate): July 30, 2015

Study Record Updates

• Last Update Posted (Estimate): January 27, 2016
• Last Update Submitted That Met QC Criteria: January 26, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Pain; Neuropathy; SFN; Small Fiber Neuropathy; Fycompa
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Small Fiber Neuropathy; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Agents; Excitatory Amino Acid Antagonists
• Other Study ID Numbers: FYCOMPA