Fycompa in Subjects With Small Fiber Neuropathy (SFN)

NCT ID: NCT02511873

Last Updated: 2016-01-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-12-31

Brief 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.

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.

Conditions

Neuropathy, Small Fiber

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fycompa

Fycompa dose is chosen based on tolerability and efficacy. 2mg to 8mg daily for 6 weeks then washed out.

Group Type: EXPERIMENTAL

Fycompa

Intervention Type: DRUG

Subjects will take Fycompa for 6 weeks with a dose range of 2mg to 8mg daily

Placebo

Inactive ingredient equal to 2mg tablets

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo (looks like study drug but has no active ingredients) for 6 weeks with a dose range of 2mg to 8mg daily

Interventions

Fycompa

Subjects will take Fycompa for 6 weeks with a dose range of 2mg to 8mg daily

Intervention Type: DRUG

Placebo

Placebo (looks like study drug but has no active ingredients) for 6 weeks with a dose range of 2mg to 8mg daily

Intervention Type: DRUG

Other Intervention Names

Perampanel; E2007; AMPA - type Glutamate Receptor Antagonist

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: collaborator

PNA Center for Neurological Research

OTHER

Sponsor Role: lead

Responsible Party

Todd Levine, MD

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Todd Levine, MD

Role: PRINCIPAL_INVESTIGATOR

PNA Center for Neurological Research

Locations

PNA Center for Neurological Research

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

FYCOMPA

Identifier Type: -

Identifier Source: org_study_id