Fycompa in Subjects With Small Fiber Neuropathy (SFN)
Status unconfirmed · Phase 2 · Has a placebo group
Conditions studied: Neuropathy, Small Fiber
In brief
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.
Key facts
- Study ID
- NCT02511873
- Run by
- PNA Center for Neurological Research
- People needed
- 30
- Starts
- 2016-01-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2016-01-27
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Small Fiber Neuropathy(SFN) proven by skin biopsy assessment of intraepidermal nerve fiber density.
- Pain scores of at least a 5 on a VAS scale.
- Male or Female 18 to 60 years old.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- Stable dose of current pain medication or any medication used for SFN 60 days prior to screening.
- Women of reproductive age must agree to use double-barrier method of contraception.
You may not qualify if…
- History of intolerance or hypersensitivity to Fycompa.
- History of psychosis, drug or alcohol abuse within the last 2 years.
- Malignancy within the last 2 years (except skin cancer).
- Clinically significant condition (including but not limited to cardiovascular or hepatic diseases and seizure disorders).
- Pregnant females, breastfeeding females, females of childbearing potential not using effective contraception.
- Subjects with other severe pain conditions which may impair the self-assessment of pain due to SFN.
- Exclusion medications for this study: Carbamazepine, Carbatrol, Tegretol, Tegretol XR, Equetro, Epitol, Phenytoin, Dilantin, Phenytek, Oxcarbazepine, Trileptal, Rifampin, Refadin, Rimactane and St. John Wort.
- Subjects with renal impairment or on hemodialysis or who have hepatic impairment.
Where it is running
- PNA Center for Neurological Research — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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