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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00291148
First Posted: February 13, 2006
Last Update Posted: July 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Manitoba
  Purpose
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.

Condition Intervention Phase
Neuropathic Pain Multiple Sclerosis Drug: paroxetine Drug: pregabalin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative Single Center, Randomized Neuropathic Pain Assessment Study Involving Patients With Clinically Definite Multiple Sclerosis (MS) Receiving Treatment With Either Pregabalin or Paroxetine

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Pain levels (as determined by weekly Visual Analogue Scale for pain) [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Short-Form 36 health outcomes survey (SF-36) [ Time Frame: 8 weeks ]
  • Short-form McGill Pain Questionnaire (SF MPQ) [ Time Frame: 8 weeks ]
  • Patient-rated Global Impression of Change (PGIC) [ Time Frame: 8 weeks ]

Estimated Enrollment: 75
Study Start Date: March 2006
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Paroxetine Drug: paroxetine
Active Comparator: pregabalin Drug: pregabalin

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291148


Locations
Canada, Manitoba
Multiple Sclerosis Clinic, Health Sciences Centre
Winnipeg, Manitoba, Canada, R3T 2N2
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Micheal P Namaka, PhD University of Manitoba
Principal Investigator: Dana A Turcotte, BSc Pharm University of Manitoba
  More Information

ClinicalTrials.gov Identifier: NCT00291148     History of Changes
Other Study ID Numbers: MS_B2005:168
First Submitted: February 10, 2006
First Posted: February 13, 2006
Last Update Posted: July 27, 2012
Last Verified: March 2011

Keywords provided by University of Manitoba:
Neuropathic pain
Multiple Sclerosis
pregabalin
paroxetine

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Neuralgia
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Pregabalin
Paroxetine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors