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

This study is currently recruiting participants.

Verified by University of Manitoba, January 2006

Sponsored by:	University of Manitoba
Information provided by:	University of Manitoba
ClinicalTrials.gov Identifier:	NCT00291148

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 III

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine Mesylate Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by University of Manitoba:

Primary Outcome Measures:

Pain levels (as determined by weekly Visual Analogue Scale for pain)

Secondary Outcome Measures:

Short-Form 36 health outcomes survey (SF-36)
Short-form McGill Pain Questionnaire (SF MPQ)
Patient-rated Global Impression of Change (PGIC)

Estimated Enrollment:	75
Study Start Date:	November 2006
Estimated Study Completion Date:	September 2008

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291148

Contacts

Contact: Micheal P Namaka, PhD

204-474-8380

namakamp@cc.umanitoba.ca

Locations

Canada, Manitoba
Multiple Sclerosis Clinic, Health Sciences Centre	Recruiting
Winnipeg, Manitoba, Canada, R3T 2N2
Contact: Micheal P Namaka, Phd (204) 474-8380 namakamp@cc.umanitoba.ca
Sub-Investigator: Andy Gomori, MD
Principal Investigator: Micheal P Namaka, PhD
Sub-Investigator: Dana A Turcotte, B.Sc Pharm
Sub-Investigator: Esfahani, MD

Sponsors and Collaborators

University of Manitoba

Investigators

Principal Investigator:	Micheal P Namaka, PhD	University of Manitoba
Study Director:	Maria Melanson, MD	University of Manitoba

More Information

Study ID Numbers:	MS_B2005:168
Study First Received:	February 10, 2006
Last Updated:	August 13, 2007
ClinicalTrials.gov Identifier:	NCT00291148
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University of Manitoba:

Neuropathic pain
Multiple Sclerosis
pregabalin
paroxetine

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Pregabalin
Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases

Sclerosis
Pain
Paroxetine
Serotonin
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions
Pathologic Processes

Serotonin Agents
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Anticonvulsants
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009