Efficacy of Dronabinol for the Treatment of Cervical Dystonia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Dystonia Medical Research Foundation
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00418925
First received: January 4, 2007
Last updated: September 8, 2008
Last verified: August 2007
  Purpose

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


Condition Intervention Phase
Cervical Dystonia
Drug: Dronabinol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II, Double Blind, Randomized, Placebo Controlled Trial of Dronabinol for the Treatment of Cervical Dystonia

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the rate and severity of adverse events within and between participants [ Time Frame: Beginning and end of each treatment ] [ Designated as safety issue: Yes ]
  • To observe changes within and between participants in the Global Impression Scale (GIS) [ Time Frame: End of each treatment ] [ Designated as safety issue: No ]
  • To observe changes within and between participants in the Visual Analog Pain Scale [ Time Frame: beginning and end of each treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 38
Study Start Date: September 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Dronabinol
    2.5 mg tablets; titrated over 14 days and 7 days steady dose
    Other Name: Marinol(R)
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. Patients will be randomized to either dronabinol or placebo by a computer-generated random numbers table that will be kept in the central pharmacy until the end of the trial. Only the central pharmacy will be aware of treatment allocation; all others will be blinded for the duration of the trial.

Regardless of treatment allocation, study participants will begin taking their assigned study medications on Day 1, increasing the "dose" (actual increase in dose for dronabinol-assigned arm, fictional increase in dose for placebo-assigned arm) every 3 days. At the end of the third week, on Day 21, the study participant will complete the first phase of study medication and remain off study medication for a period of two weeks, and will have a planned study visit. On Day 36, the study participant will have a planned study visit, the new medication will be dispensed, and the participant will begin taking the other arm of the study medication for a period of 3 weeks, in the same manner as the first arm. At the end of the 3 weeks (8 weeks in total), the study participant will discontinue the assigned study medication and will attend a planned study visit for study termination. At each visit, patients will be assessed with a medical and neurological history and examination and a video recording made for post hoc analysis of TWSTRS by a rater blinded to the treatment arm.

The main issue with compliance to study medication will relate to side-effects. Side-effects are mainly dose related and can be minimized with a dose escalation protocol, which is planned in this study. Compliance and adverse effects will be monitored by weekly phone calls for side effects and pill counts at the end of each treatment arm.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418925

Contacts
Contact: Susan H Fox, MD PhD 416 603 5875 ext 5 sfox@uhnresearch.ca

Locations
Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Susan H Fox, MD PhD    416 603 5875 ext 3    sfox@uhnresearch.ca   
Sponsors and Collaborators
University Health Network, Toronto
Dystonia Medical Research Foundation
Investigators
Principal Investigator: Susan H Fox, MD PhD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: Susan Fox, UHN Toronto
ClinicalTrials.gov Identifier: NCT00418925     History of Changes
Other Study ID Numbers: MDC DRO 2006
Study First Received: January 4, 2007
Last Updated: September 8, 2008
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Tetrahydrocannabinol
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 28, 2014