Fycompa in Subjects With Small Fiber Neuropathy (SFN)

PNA Center for Neurological Research

Status and phase: Unknown; Phase 2

Conditions: Neuropathy, Small Fiber

Treatments: Drug: Placebo; Drug: Fycompa

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02511873

FYCOMPA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups, including a placebo group

Fycompa

Experimental group

Description:

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

Treatment:

Drug: Fycompa

Placebo

Placebo Comparator group

Description:

Inactive ingredient equal to 2mg tablets

Treatment:

Drug: Placebo