Status:
COMPLETED
Neuropathic Pain Assessment Comparing Pregabalin and Paroxetine in Management of MS-induced Neuropathic Pain
Lead Sponsor:
University of Manitoba
Conditions:
Neuropathic Pain
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This is a comparative drug trial involving patients with clinically definite Multiple Sclerosis and documented neuropathic pain. Patients will be randomized to receive treatment with either paroxetine...
Detailed Description
General Objective: To determine the effectiveness of drug treatment in the management of MS-induced neuropathic pain. Specific Objectives: * Comparatively assess the effectiveness and safety profil...
Eligibility Criteria
Inclusion
- • Patients presenting with symptoms of neuropathic pain as determined by clinician, with a minimum VAS pain score of 40mm as determined by a baseline score (0mm = no pain, 100mm = worst pain).
- Male and female patients between the ages of 18 and 65 years old.
- Clinically definite multiple sclerosis as defined by clinical history review, neurological examination and positive MRI.
- EDSS scores of \< 6.0.
- No known hypersensitivity to the study medications.
- Negative serum pregnancy test for all female patients of childbearing age; not currently breastfeeding.
- Not currently treated with pregabalin, gabapentin, paroxetine or another SSRI.
- No previous treatment failures with pregabalin or paroxetine.
- Baseline creatinine clearance (Clcr) of \> 50mL/min.
- No significant hepatic insufficiency.
- If on other pain medications, must be on stable dose for at least 6 months and other medications must not elicit significant drug-drug interactions with study medications.
Exclusion
- \-
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2012
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00291148
Start Date
March 1 2006
End Date
July 1 2012
Last Update
July 27 2012
Active Locations (1)
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1
Multiple Sclerosis Clinic, Health Sciences Centre
Winnipeg, Manitoba, Canada, R3T 2N2