Fycompa in Subjects With Small Fiber Neuropathy (SFN)

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PNA Center for Neurological Research
• Collaborator: Eisai Inc.
• Treatments: Excitatory Amino Acid Antagonists

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.