Status:
UNKNOWN
Efficacy of Dronabinol for the Treatment of Cervical Dystonia
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Dystonia Medical Research Foundation
Conditions:
Cervical Dystonia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 disablin...
Detailed Description
The study is a double-blind, randomized, placebo-controlled, crossover, phase II study of dronabinol versus placebo. Thirty patients with idiopathic cervical dystonia will be enrolled in the study. Pa...
Eligibility Criteria
Inclusion
- 18-75 year old male and female patients with idiopathic cervical dystonia -
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00418925
Start Date
September 1 2006
End Date
December 1 2009
Last Update
September 9 2008
Active Locations (1)
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1
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8