The Effect of Medical Cannabis on Tics, Premonitory Urge & Psychiatric

Status Completed

Clinical Trial Summary

Medical cannabis (MC) is a standard treatment in Israel to adults with resistant Gilles de la Tourette syndrome (GTS). While small randomized control trials assessed THC efficacy on tics and premonitory urge, only small retrospective studies assessed MC efficacy and tolerability in GTS. Herein, By using an open-label, prospective design, our aim is to determine the preferred method of use, efficacy and tolerability of 12 weeks of treatment with MC in adult patients with GTS.

Clinical Trial Description

Gilles de la Tourette syndrome (GTS) is a childhood onset neuropsychiatric disorder characterized by the presence of multiple motor and one or more phonic tics continuing for at least one year. In Israel, although consumption of cannabis is outlawed, there is an option to allow patients to consume the drug under supervision. Medical Cannabis (MC) consumed by inhalation of smoked or vaporized dried female buds, or subligual oil extract of whole plant, has been an approved treatment by the Ministry of Health (MOH) for resistant GTS since 2013. Previous studies suggested that MC has a good effect on tics, quality of like and with good tolerability among patients with resistant GTS. In the current study, we prospectively followed-up patients eligible for MC according to MOH restrictions, at our GTS clinic at the Tel-Aviv Sourasky Movement Disorders Unit (MDU). Each subject signed a written informed consent before inclusion in the trial. Also, since driving under the influence of cannabis is forbidden by the Israeli law, patients were instructed and gave their oral commitment to avoid driving. The study was approved by the research ethics (Helsinki) committee at our center. MC was consumed as oil extract, vaporized, or smoked dried buds. The treating neurologist (S.A.) and patient together decided on the method of consumption during the visit before initiating treatment. Patients were assessed 4 and 12-weeks following treatment initiation to gather data regarding treatment efficacy, tolerability and SEs. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05115318
Study type	Observational
Source	Tel-Aviv Sourasky Medical Center
Contact
Status	Completed
Phase
Start date	July 1, 2020
Completion date	March 31, 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04851678` - Longitudinal Impact of Stressors in Adults With Tourette Syndrome
Completed	`NCT02605902` - Trial to Demonstrate the Efficacy and Safety of Internet-delivered Behavioral Treatment for Adults With Tic Disorders	N/A
Completed	`NCT04007913` - Incorporating teleCBIT Into a Hospital-Based Tic Program	N/A
Completed	`NCT02900144` - Modified Comprehensive Behavioral Intervention for Tics (M_CBIT)	N/A
Completed	`NCT02216474` - Brain Stimulation in Movement Disorders	N/A
Completed	`NCT02256475` - Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome	Phase 1
Completed	`NCT01329198` - Brain Stimulation for the Treatment of Tourette Syndrome	N/A
Terminated	`NCT00952601` - Pilot Study of the Modified Atkins Diet for Tourette Syndrome	Phase 1
Enrolling by invitation	`NCT00355927` - Sedation During Microelectrode Recordings Before Deep Brain Stimulation for Movement Disorders.	N/A
Completed	`NCT00206323` - A Randomized, Placebo-controlled, Tourette Syndrome Study.	Phase 3
Completed	`NCT00004376` - Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder	Phase 3
Completed	`NCT04498364` - Extinction Learning in Adults With Tourette Syndrome	N/A
Completed	`NCT00755339` - Role of the Sensory Experience in Generating Motor Tics in Tourette Syndrome
Completed	`NCT03325010` - Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome	Phase 2
Not yet recruiting	`NCT06081348` - Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders	Phase 2
Completed	`NCT01702077` - Neurofeedback for Tourette Syndrome	N/A
Completed	`NCT01719523` - Open-Trial of EPI-743 for Adults With Tourette Syndrome	Phase 1
Completed	`NCT00231985` - Effectiveness of Behavior Therapy and Psychosocial Therapy for the Treatment of Tourette Syndrome and Chronic Tic Disorder	Phase 2
Completed	`NCT00206336` - An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome.	Phase 3
Terminated	`NCT03732534` - Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette Syndrome	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Effect of Medical Cannabis on Tics, Premonitory Urge and Psychiatric Comorbidity in Adults With Tourette Syndrome

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms