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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT00418925
Other study ID # MDC DRO 2006
Secondary ID
Status Unknown status
Phase Phase 2
First received January 4, 2007
Last updated September 8, 2008
Start date September 2006
Est. completion date December 2009

Study information

Verified date August 2007
Source University Health Network, Toronto
Contact Susan H Fox, MD PhD
Phone 416 603 5875
Email sfox@uhnresearch.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Unknown status
Enrollment 38
Est. completion date December 2009
Est. primary completion date November 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada Toronto Western Hospital Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
University Health Network, Toronto Dystonia Medical Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)with 3 weeks of active treatment compared to placebo beginning and end of each treatment
Secondary To determine the rate and severity of adverse events within and between participants Beginning and end of each treatment
Secondary To observe changes within and between participants in the Global Impression Scale (GIS) End of each treatment
Secondary To observe changes within and between participants in the Visual Analog Pain Scale beginning and end of each treatment
See also
  Status Clinical Trial Phase
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Not yet recruiting NCT04057911 - A Trial of Non-invasive Stimulation in Cervical Dystonia N/A
Withdrawn NCT02180139 - tDCS in Cervical Dystonia N/A
Completed NCT00541905 - Daily Dystonia Practice - A Trial to Investigate NT 201, the Duration of Treatment Effect After One Injection Session and in Long-term Treatment in Cervical Dystonia Phase 4
Not yet recruiting NCT05715138 - Comparison of Pallidal With Subthalamic Deep Brain Stimulation for Cervical Dystonia N/A
Completed NCT02131467 - Safety and Tolerability of Perampanel in Cervical Dystonia Phase 1/Phase 2
Completed NCT02959645 - Assessment of Brain Activities in Cervical Dystonia
Completed NCT03805152 - Abobotulinum Toxin and Neubotulinum Toxin Injection in Cerivical Dystonia Phase 3
Completed NCT04949594 - Relief of Pain in Patients With Cervical Dystonia Through the Use of Transcutaneous Electric Nerve Stimulation (TENS)
Recruiting NCT01664013 - The Impact of Botulinum Toxin Treatment in Quality of Life of Cervical Dystonia Patients Phase 4
Completed NCT00210431 - Post Marketing Surveillance Study of Dysport
Completed NCT00447772 - Study to Assess the Efficacy and Safety of Dysport® in Cervical Dystonia Phase 3
Completed NCT05157100 - Clinical Study of Ingrezza (Valbenazine) for the Treatment of Cervical Dystonia Phase 4
Completed NCT00257660 - Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia Phase 3
Completed NCT05103202 - Efficacy and Safety of 10-Week or Shorter vs 12-Week or Longer Injection Intervals of Botulinum Toxin
Terminated NCT00760318 - Keppra for Cervical Dystonia Phase 2
Completed NCT00323765 - Plasticity in Cervical Dystonia N/A
Completed NCT04171258 - Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With Cervical Dystonia Phase 1
Completed NCT04849988 - A Phase 2 Study to Evaluate the Safety and Efficacy of ABP-450 in the Treatment of Cervical Dystonia Phase 2
Completed NCT03471923 - Non-Motor Features of Cervical Dystonia (CD)