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| 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 |
| 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 |
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).
Exclusion Criteria:
-
Contacts and Locations| Contact: Micheal P Namaka, PhD | 204-474-8380 | namakamp@cc.umanitoba.ca |
| 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 | |
| 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 |
| Study First Received: | February 10, 2006 |
| Last Updated: | March 24, 2011 |
| Health Authority: | Canada: Ethics Review Committee |
|
Neuropathic pain Multiple Sclerosis pregabalin paroxetine |
|
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 |