Efficacy of Dronabinol for the Treatment of Cervical Dystonia

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ClinicalTrials.gov Identifier: NCT00418925

Recruitment Status : Unknown

Verified August 2007 by University Health Network, Toronto.
Recruitment status was: Recruiting

First Posted : January 5, 2007

Last Update Posted : September 9, 2008

Sponsor:

Collaborator:

Dystonia Medical Research Foundation

Information provided by:

University Health Network, Toronto

Study Description

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

Condition or disease	Intervention/treatment	Phase
Cervical Dystonia	Drug: Dronabinol	Phase 2

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	38 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Phase II, Double Blind, Randomized, Placebo Controlled Trial of Dronabinol for the Treatment of Cervical Dystonia
Study Start Date :	September 2006
Estimated Primary Completion Date :	November 2009
Estimated Study Completion Date :	December 2009

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Dopa-responsive dystonia Early-onset primary dystonia

MedlinePlus related topics: Dystonia

Drug Information available for: Dronabinol

Genetic and Rare Diseases Information Center resources: Cervical Dystonia

U.S. FDA Resources

Arms and Interventions

Intervention Details:

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

Other Name: Marinol(R)

Outcome Measures

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 ]

Secondary Outcome Measures :

To determine the rate and severity of adverse events within and between participants [ Time Frame: Beginning and end of each treatment ]
To observe changes within and between participants in the Global Impression Scale (GIS) [ Time Frame: End of each treatment ]
To observe changes within and between participants in the Visual Analog Pain Scale [ Time Frame: beginning and end of each treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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


Responsible Party:	Susan Fox, UHN Toronto
ClinicalTrials.gov Identifier:	NCT00418925 History of Changes
Other Study ID Numbers:	MDC DRO 2006
First Posted:	January 5, 2007 Key Record Dates
Last Update Posted:	September 9, 2008
Last Verified:	August 2007

Additional relevant MeSH terms:


Dystonia Dystonic Disorders Torticollis Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Movement Disorders Central Nervous System Diseases Dronabinol Hallucinogens Physiological Effects of Drugs	Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Cannabinoid Receptor Agonists Cannabinoid Receptor Modulators Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hormones Hormones, Hormone Substitutes, and Hormone Antagonists

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