Neuropathic Pain Assessment Comparing Pregabalin and Paroxetine in Management of MS-induced Neuropathic Pain

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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 or pregabalin. After dose titration, participants will complete various pain scale assessments at several points during the study in order to determine the effectiveness of their assigned pain medication.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Manitoba
• Treatments: Paroxetine; Pregabalin

Criteria

Inclusion Criteria:

• • 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 Criteria:

-