NEMA TO STUDY SYNTHETIC CANNABINOID FOR NEUROPATHIC PAIN
Nema Research has initiated three Phase IV, multicenter, open-label clinical trials to evaluate the safety and efficacy of the synthetic cannabinoid nabilone, Cesamet, used as an adjuvant therapy for patients on stable analgesic regimens who still experience neuropathic pain associated with diabetic peripheral neuropathy, multiple sclerosis or chemotherapy. Nabilone is currently approved by the FDA to treat chemotherapy-induced nausea and vomiting in patients who failed to respond adequately to conventional anti-emetic treatments.
Treatment of neuropathic pain is still difficult despite new treatments, and there is no single treatment that works for all conditions and their underlying mechanisms. Nema investigators will research the potential use of nabilone as an adjuvant therapy to help address oligoanalgesia, or the practice of inadequate analgesia. Oligoanalgesia may lead to undertreatment of pain in those patients with disease states inherent to neuropathic pain.
Each clinical trial will have two phases: a pretreatment phase and a treatment phase. Patients will receive 1 mg of nabilone daily, progressing to 2 mg. Patients will be evaluated for primary outcomes (the average pain score at target site) as well as secondary outcomes (the worst pain score at target site, the pain at night score at target site, quality of life measures and patient satisfaction with treatment). Safety will be assessed through the collection of adverse events and vital signs. Combined enrollment in the three studies is expected to be approximately 70 patients.
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