Evaluation of Pregabalin in Idiopathic Small Fiber Neuropathy

• Status: Terminated
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Idiopathic Small Fiber Neuropathy (called SFN for short), is a condition where nerves that sense pain have become damaged, and often painful. SFN pain is common, and it can affect sleep, memory, health and overall quality of life.

Pregabalin is a drug commonly used to treat painful conditions, like nerve pain. It has been available to doctors for many years, and many studies have been performed to evaluate its effectiveness. In these studies, pregabalin has been shown to be very effective in the treatment of nerve pain, with fewer side effects than many other medications currently available. The purpose of the study is to determine if pregabalin relieves pain more effectively than a pill containing no medication (called a placebo). The study will also investigate any side effects as well as the effectiveness and safety of the medication.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alberta
• Collaborator: Capital Health, Canada
• Treatments: Pregabalin

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.