Efficacy and Safety Evaluation of Nabilone as Adjunctive Therapy to Gabapentin for the Management of Neuropathic Pain in Multiple Sclerosis - Full Text View

Sponsor:	University of Manitoba
Collaborator:	Valeant Pharmaceuticals North America
Information provided by:	University of Manitoba
ClinicalTrials.gov Identifier:	NCT00480181

Purpose

The purpose of this study is to determine whether nabilone (Cesamet) when used as an adjunctive agent with gabapentin (Neurontin) provides significantly improved pain relief over gabapentin alone for the management of neuropathic pain in MS.

Condition	Intervention	Phase
Neuropathic Pain Multiple Sclerosis	Drug: nabilone Other: placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Comparative, Single Center, Randomized, Double-blinded, Parallel, Placebo-controlled Study to Evaluate the Efficacy of Nabilone (Cesamet) as Adjunctive Therapy to Gabapentin (Neurontin) in the Management of Neuropathic Pain (NPP) Symptoms in Subjects With Multiple Sclerosis (MS)

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Nabilone Gabapentin

U.S. FDA Resources

Further study details as provided by University of Manitoba:

Primary Outcome Measures:

VAS [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

SF MPQ [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
SF-36 [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
PGIC [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	June 2007
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active: Experimental	Drug: nabilone Cesamet (nabilone) capsules given at titrating dosages as per protocol.
placebo: Placebo Comparator	Other: placebo placebo capsules (identical appearance to Cesamet) given at titrating dosages as per protocol.

Detailed Description:

Neuropathic pain syndromes, which occur due to damage to central and/or peripheral nerve axons, are often more difficult to manage and are commonly refractory to the conventional analgesia approach described by the World Health Organization, including NSAIDs and narcotic agents. These pain syndromes are often described by symptoms of burning, stabbing, crawling, shock-like, numbness and/or tingling, and can be quite concerning to the patient, especially when there is an inadequate response to treatment. It has been estimated that the prevalence of chronic pain in MS ranges anywhere from 30-90%, placing it as the second worst disease-induced symptom experienced by this patient population.

The pathophysiologic causes of this pain syndrome are complex and multifaceted, with no one specific link attributed to the pain response. Due to the complexity of neuropathic pain - which is only partially understood at best - it may be necessary in many cases to treat the source of the pain with more than one agent in order to address the many different contributors to this pain process. More thorough review of how the currently available agents for NPP work together would provide clinicians with safety and efficacy data which would aid in providing optimal pain management.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and females between the ages of 18-65 years old with clinically definite RRMS
EDSS of < 6.5
Current treatment with gabapentin that is not effective at a stabilized dose of (>1800mg/day) for at least 1 month.
Visual Analogue Scale score for NPP symptoms > 5; pain present for at least 3 months
Negative serum pregnancy test for all females of childbearing age; not currently breastfeeding
No history of alcohol or substance abuse
No history of non-psychotic emotional disorders
No significant hepatic or renal insufficiency
No significant cardiovascular disease or hypertension
No known hypersensitivity and/or allergy to nabilone or its derivatives
No current use of cannabinoid or related products

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480181

Contacts

Contact: Michael P Namaka, PhD

(204)474-8380

namakamp@ms.umanitoba.ca

Locations

Canada, Manitoba
Health Sciences Centre Multiple Sclerosis Clinic	Recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Sub-Investigator: Dana A Turcotte, B.Sc Pharm
Principal Investigator: Andrew Gomori, MD
Principal Investigator: Farid Esfahani, MD

Sponsors and Collaborators

University of Manitoba

Valeant Pharmaceuticals North America

Investigators

Principal Investigator:

Michael P Namaka, PhD

University of Manitoba

More Information

No publications provided

Responsible Party:	University of Manitoba ( Dr. M. Namaka )
Study ID Numbers:	B2007:051
Study First Received:	May 28, 2007
Last Updated:	August 20, 2009
ClinicalTrials.gov Identifier:	NCT00480181 History of Changes
Health Authority:	Canada: Biomedical Research Ethics Board

Keywords provided by University of Manitoba:

Neuropathic pain
Multiple Sclerosis
Nabilone
Gabapentin

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Gabapentin
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Calcium Channel Blockers
Antiparkinson Agents
Excitatory Amino Acid Agents
Pain
Nabilone
Membrane Transport Modulators
Signs and Symptoms
Pathologic Processes

Multiple Sclerosis
Neuromuscular Diseases
Sensory System Agents
Therapeutic Uses
Analgesics
Autoimmune Diseases of the Nervous System
Excitatory Amino Acid Antagonists
Tranquilizing Agents
Autoimmune Diseases
Immune System Diseases
Demyelinating Diseases
Neuralgia
Nervous System Diseases
Gastrointestinal Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on February 09, 2010