Efficacy of Dronabinol for the Treatment of Cervical Dystonia

• Status: Unknown status
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Cervical dystonia (CD) is characterized by abnormal, involuntary sustained cervical muscles contractions associated with twisting movements and abnormal postures of the neck that can be quite disabling. Currently there are no good oral medications for the treatment of CD. While botulinum toxin injections are effective in most, they require repeat injections and there are some patients who either stop responding or who never respond at all. Therefore, better treatments are needed. While the underlying mechanisms of dystonia are not entirely known, there is some information suggesting that it is ude to an underactivity of a chemical compound, GABA, that is located in the basal ganglia. Cannabinoids are a compound than can enhance transmission of GABA, and thus, may alleviate the symptoms of dystonia. Dronabinol, one such cannabinoid, has been widely used to treat anorexia and nausea in chemotherapeutic patients. The aim of this study, therefore, is to study the effect of dronabinol on cervical dystonia

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: Dystonia Medical Research Foundation
• Treatments: Dronabinol

Criteria

Inclusion Criteria:

• 18-75 year old male and female patients with idiopathic cervical dystonia -

Exclusion Criteria:

• Secondary causes of dystonia; history of substance abuse, psychosis, ischemic heart disease, symptomatic postural hypotension, liver disease (LFTs > 2 times normal), renal disease

• Women who are pregnant or plan on becoming pregnant during the course of the trial

• Use of botulinum toxin as a treatment for cervical dystonia in the preceding 4 months

• Use of other GABA mediated drugs including: gabapentin, phenobarbital, benzodiazepines, or baclofen

• Use of other cannabinoids in the preceding month

• Refusal to refrain from use of other cannabinoid compounds during the course of the trial

• Refusal to refrain from operating heavy machinery or driving during the course of the trial