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
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.
1. Small Fiber Neuropathy(SFN) proven by skin biopsy assessment of intraepidermal nerve
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
6. Women of reproductive age must agree to use double-barrier method of contraception.
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
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.