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

Sponsor:	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
Neuralgia Multiple Sclerosis	Drug: paroxetine Drug: pregabalin Drug: Paroxetine	Phase III

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:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine hydrochloride hemihydrate Pregabalin Paroxetine Mesylate

U.S. FDA Resources

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:	November 2006
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	December 2011 (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

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

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:	March 24, 2011
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 February 09, 2012