NCT00291148CompletedPhase 3
A Comparative Single Center, Randomized Neuropathic Pain Assessment Study Involving Patients With Clinically Definite Multiple Sclerosis (MS) Receiving Treatment With Either Pregabalin or Paroxetine
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- University of Manitoba
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Pain levels (as determined by weekly Visual Analogue Scale for pain)
Study Overview
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 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.
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 profile of pregabalin (Lyrica) and paroxetine (Paxil) in managing MS-induced neuropathic pain.
- Comparatively assess the effectiveness of pregabalin (Lyrica) and paroxetine (Paxil) in improving the quality-of-life associated with MS-induced neuropathic pain.
Study Design:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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
- Not provided
Arms & Interventions
Paroxetine
Active Comparator
Intervention: paroxetine (Drug)
pregabalin
Active Comparator
Intervention: pregabalin (Drug)
Outcomes
Primary Outcomes
Pain levels (as determined by weekly Visual Analogue Scale for pain)
Time Frame: 8 weeks
Secondary Outcomes
- Short-Form 36 health outcomes survey (SF-36)(8 weeks)
- Short-form McGill Pain Questionnaire (SF MPQ)(8 weeks)
- Patient-rated Global Impression of Change (PGIC)(8 weeks)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 4
Comparison of the Efficacy and Safety of Clindamycin + Benzoyl Peroxide Formulation With Azelaic Acid Formulation in the Treatment of Acne VulgarisAcne VulgarisNCT02058628GlaxoSmithKline222
Completed
Not Applicable
Efficacy of Moxibustion Therapy With or Without Smoke for Knee OsteoarthritisPainNCT02772055Chengdu University of Traditional Chinese Medicine138
Completed
Not Applicable
Evaluation of the Efficacy and Safety of DM934 Versus Théalose on Eye DrynessDry EyeNCT06245421Horus Pharma85
Completed
Phase 3
Comparative Study of BAT2506 With Simponi® in Participants With Active Psoriatic ArthritisPsoriatic ArthritisNCT05046431Bio-Thera Solutions704
Unknown
Not Applicable
Evaluation of Neovis® Total Multi Versus Systane® Balance on Ocular Dryness Associated With Meibomian Gland DysfunctionDry EyeMeibomian Gland DysfunctionNCT05191771Horus Pharma120