NCT00418925

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

September 9, 2008

Status Verified

August 1, 2007

Enrollment Period

3.2 years

First QC Date

January 4, 2007

Last Update Submit

September 8, 2008

Conditions

Cervical Dystonia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • To determine the rate and severity of adverse events within and between participants

    Beginning and end of each treatment

  • To observe changes within and between participants in the Global Impression Scale (GIS)

    End of each treatment

  • To observe changes within and between participants in the Visual Analog Pain Scale

    beginning and end of each treatment

Interventions

DronabinolDRUG

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

Also known as: Marinol(R)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • year old male and female patients with idiopathic cervical dystonia -

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Torticollis

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

DystoniaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Susan H Fox, MD PhD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan H Fox, MD PhD

CONTACT

416 603 5875sfox@uhnresearch.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2007

First Posted

January 5, 2007

Study Start

September 1, 2006

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

September 9, 2008

Record last verified: 2007-08

Locations

CA(1)