Status:
TERMINATED
Evaluation of Pregabalin in Idiopathic Small Fiber Neuropathy
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Capital Health, Canada
Conditions:
Small-Fiber Neuropathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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, healt...
Detailed Description
Painful small fiber sensory neuropathy (SFN) is relatively common and a disabling medical condition. It is the most common type of painful sensory neuropathy in patients older than 50 years of age. It...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00787462
Start Date
February 1 2008
End Date
February 1 2013
Last Update
August 28 2017
Active Locations (1)
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1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G-2B7