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

This study has been completed.
Sponsor:
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00291148
First received: February 10, 2006
Last updated: July 26, 2012
Last verified: March 2011
  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
Drug: Paroxetine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Short-Form 36 health outcomes survey (SF-36) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Short-form McGill Pain Questionnaire (SF MPQ) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Patient-rated Global Impression of Change (PGIC) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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 Drug: Paroxetine
Active Comparator: pregabalin Drug: pregabalin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00291148     History of Changes
Other Study ID Numbers: MS_B2005:168
Study First Received: February 10, 2006
Last Updated: July 26, 2012
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Multiple Sclerosis
Neuralgia
Sclerosis
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
Pathologic Processes
Paroxetine
Pregabalin
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Analgesics

ClinicalTrials.gov processed this record on August 26, 2014