Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00418925
Status:
UNKNOWN
Last Update Posted:
2008-09-09
First Post:
2007-01-04
Brief Title:
Efficacy of Dronabinol for the Treatment of Cervical Dystonia
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Phase II Double Blind Randomized Placebo Controlled Trial of Dronabinol for the Treatment of Cervical Dystonia
Status:
UNKNOWN
Status Verified Date:
2007-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None