Evaluation of Pregabalin in Idiopathic Small Fiber Neuropathy
Small-Fiber Neuropathy
About this trial
This is an interventional treatment trial for Small-Fiber Neuropathy focused on measuring Neuropathic, Neuropathic pain, Nerve pain, Pain, Chronic pain, Pregabalin, Lyrica, Small fiber neuropathy, Neuropathy
Eligibility Criteria
Inclusion Criteria:
- A diagnosis of idiopathic SFN (based on clinical and electrodiagnostic criteria).
- Each day for 7 days prior to Visit 2 (Washout) they must complete a modified Quadruple Visual Analogue Scale₁ showing moderate to severe pain (i.e. a daily mean rating score of ≥ 4).
- As the safety of pregabalin in pregnancy has not been established, females of childbearing potential must have a negative βHCG serum and agree to practice acceptable birth control methods.
- All subjects must have screening laboratory values that are within normal limits or abnormal values that are deemed not clinically significant by the Principle Investigator.
Exclusion Criteria:
- Have a psychological or psychiatric condition that may hinder their ability to provide important information
- History of psychosis, drug or alcohol abuse history within the last year
- Malignancy within the last 2 years (except skin cancer)
- Clinically significant conditions (including but not limited to cardiovascular or hepatic diseases), and seizure disorders.
- Subjects with an abnormal 2-hour glucose tolerance test (i.e., glucose >7.8 mmol/l) will be excluded under "clinically significant conditions" as stated above.
- May not have participated in a previous trial of pregabalin, have a history of intolerance or hypersensitivity to pregabalin.
- Patients with renal impairment (CrCl < 60 ml/min) will be excluded.
Sites / Locations
- University of Alberta Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Active
Placebo
Available as 75 mg capsules. Subjects will begin Phase 1 treatment on either pregabalin (or placebo) 75mg BID (1 capsule BID) for one week then increasing to 150mg BID or placebo (2 capsules BID) for a further 7 weeks. During this period patients will be allowed to taper the drug to 225mg a day (75mg in am, 150mg in pm) or (75mg BID) if they develop significant adverse effects on the higher dose. After 8 weeks Phase 1 treatment subjects will taper study medication to 75mg BID or placebo (1 capsule BID) for 7 days and then continue taking placebo (1 capsule) for 7 additional days prior to the crossover. After the taper and washout, Phase 2 will begin using the alternate treatment and will follow the same dosing regime as Phase 1 for the remaining 10 weeks.
Available as 75 mg capsules. Subjects will begin Phase 1 treatment on either pregabalin (or placebo) 75mg BID (1 capsule BID) for one week then increasing to 150mg BID or placebo (2 capsules BID) for a further 7 weeks. During this period patients will be allowed to taper the drug to 225mg a day (75mg in am, 150mg in pm) or (75mg BID) if they develop significant adverse effects on the higher dose. After 8 weeks Phase 1 treatment subjects will taper study medication to 75mg BID or placebo (1 capsule BID) for 7 days and then continue taking placebo (1 capsule) for 7 additional days prior to the crossover. After the taper and washout, Phase 2 will begin using the alternate treatment and will follow the same dosing regime as Phase 1 for the remaining 10 weeks.