Recruiting
Phase 2

Dronabinol

Sponsor:

University Health Network, Toronto

Code:

NCT00418925

Conditions

Cervical Dystonia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Dronabinol

Study Details

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 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

Conditions

Cervical Dystonia

Study ID

NCT00418925

Start date

Sep, 2006

Status verified date

Aug, 2007

Completion date

Dec, 2009

Anticipated

Primary completion date

Nov, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

38 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Dronabinol

2.5 mg tablets; titrated over 14 days and 7 days steady dose

Primary outcome measure

  • Change in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)with 3 weeks of active treatment compared to placebo [ Time Frame: beginning and end of each treatment ]

Central Contacts and Locations

Central contacts

Susan H Fox, MD PhD

416 603 5875sfox@uhnresearch.ca

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Susan H Fox, MD PhD

416 603 5875sfox@uhnresearch.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Sep 9, 2008

Last verified

Aug, 2007

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2008-09-09.