Efficacy and Safety Evaluation of Nabilone as Adjunctive Therapy to Gabapentin for the Management of Neuropathic Pain in Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT00480181|
Recruitment Status : Completed
First Posted : May 30, 2007
Last Update Posted : July 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Neuropathic Pain Multiple Sclerosis||Drug: nabilone Other: placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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)|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
Cesamet (nabilone) capsules given at titrating dosages as per protocol.
Other Name: Cesamet
|Placebo Comparator: placebo||
placebo capsules (identical appearance to Cesamet) given at titrating dosages as per protocol.
- VAS [ Time Frame: 9 weeks ]
- SF MPQ [ Time Frame: 9 weeks ]
- SF-36 [ Time Frame: 9 weeks ]
- PGIC [ Time Frame: 9 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00480181
|Health Sciences Centre Multiple Sclerosis Clinic|
|Winnipeg, Manitoba, Canada, R3A 1R9|
|Principal Investigator:||Michael P Namaka, PhD||University of Manitoba|