Cervical DystoniaPhase 2NCT00418925
Efficacy of Dronabinol for the Treatment of Cervical Dystonia
A Phase 2 study testing Dronabinol in people with Cervical Dystonia, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cervical Dystonia
- What is being tested?
- Dronabinol
- Type of treatment
- Pill or oral medicine
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2006to Dec 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 year old male and female patients with idiopathic cervical dystonia -
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Susan H Fox, MD PhD, 416 603 5875 ext. 3, sfox@uhnresearch.ca
About this study
Official title: Phase II, Double Blind, Randomized, Placebo Controlled Trial of Dronabinol for the Treatment of Cervical Dystonia
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
Read the 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.
- Conditions
- Cervical Dystonia
- Being tested
- Dronabinol
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DronabinolDrug
Also called Marinol(R)
2.5 mg tablets; titrated over 14 days and 7 days steady dose
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)with 3 weeks of active treatment compared to placebo
Measured: beginning and end of each treatment
Secondary outcomes (3)
To determine the rate and severity of adverse events within and between participants
Measured: Beginning and end of each treatment
To observe changes within and between participants in the Global Impression Scale (GIS)
Measured: End of each treatment
To observe changes within and between participants in the Visual Analog Pain Scale
Measured: beginning and end of each treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2007 (estimated)
- Study startSep 2006
- Primary completionNov 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical DystoniaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Dystonia Medical Research Foundation
- Investigators
- Susan H Fox, MD PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418925
- Sponsor's protocol ID
- MDC DRO 2006
- Status last verified
- Aug 2007
- First submitted
- 4 Jan 2007
- Last updated
- 9 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Double Blind, Randomized, Placebo Controlled Trial of Dronabinol for the Treatment of Cervical Dystonia
- ClinicalTrials.gov ID
- NCT00418925
- Acronym / sponsor ID
- MDC DRO 2006
- Conditions
- Cervical Dystonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Dystonia Medical Research Foundation
- Study start
- Sep 2006
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 5 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-75 year old male and female patients with idiopathic cervical dystonia -
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DronabinolAlso: Marinol(R)2.5 mg tablets; titrated over 14 days and 7 days steady dose | Drug | – |
Primary outcome
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
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2008.
Related trials for Cervical Dystonia
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A Study to Evaluate the Efficacy, Safety, and Tolerability of VIM0423 in Individuals With Isolated Dystonia
Dystonia
Not yet recruitingObservational study
Assessment of Cervical Range of Motion Restrictions in Infants With Arthrogenic Torticollis - A Feasibility Study
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Effect of Vibro-tactile Stimulation Intensity on Head Posture in Cervical Dystonia
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An Observational Study of Individuals With Isolated Dystonia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan H Fox, MD PhD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dronabinol in people with Cervical Dystonia, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susan H Fox, MD PhD (416 603 5875 ext. 5, sfox@uhnresearch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2008.