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Safety and Efficacy of Cannabis in Tourette Syndrome

Primary Purpose

Tourette Syndrome

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Cannabis
Cannabis
Cannabis
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette Syndrome focused on measuring Cannabis, Tics, Tourette Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female adult, 18-65 years of age (inclusive) at the time of signing the informed consent.
  • The subject meets current DSM-5 diagnostic criteria for TS[6], diagnosed by a neuropsychiatrist with expertise in TS and related conditions.
  • YGTSS-TTS ≥16, frequency subscore = 5 and intensity subscore ≥ 2. In addition, tic free intervals do not last more than two minutes based on both self-reporting and observation by clinician at both screening and Week 0 (randomization). This requirement is for the purpose of minimizing the potential for floor effects given the relatively short window for assessing effect on symptoms in this single-dose trial.
  • The subject is able and willing to refrain from using any non-study cannabis during the screening and treatment phases of the study.
  • Females of childbearing potential (defined by menarche and not having undergone surgical sterilization/hysterectomy) must have a negative pregnancy test, must be practicing acceptable double-barrier methods of contraception (or can confirm abstinence at each scheduled visit), and must not be breast feeding.
  • Written informed consent must be obtained from the subject prior to the initiation of any protocol-required procedures.
  • The subject is able to comprehend and satisfactorily comply with the protocol requirements.

Exclusion Criteria:

  • • The subject and/or his/her family have a history of psychosis, schizophrenia or bipolar disorder.

    • Sexually active females of childbearing potential who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial; Females who are breast-feeding and/or who have a positive serum pregnancy test result prior at the time of screening.
    • The subject represents a significant risk of committing suicide (current suicide plan or attempt in past 2 years) or committing homicide.
    • The subject has a history of serious head injury, seizure disorder, or developmental delay (intelligence quotient≤85).
    • The subject has either of: cardiovascular disease; respiratory disease such as chronic obstructive pulmonary disease (COPD) or lung cancer (asthma is not an exclusionary criterion); hepatitis.
    • The subject has a current or past history of substance abuse within the last 5 years, with the exception of cannabis.
    • The subject is using cannabis regularly for the treatment of TS.
    • The subject has any abnormal laboratory tests and vital sign results which in the investigator's judgment is medically significant and would impact the safety of the subject or the interpretation of the study results.

Sites / Locations

  • Toronto Western Hospital - Tourette Syndrome Neurodevelopmental Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

1

2

3

4

Arm Description

Three cannabis drug product formulations with different THC and CBD contents and placebo will be used in the following order: A (THC 10%, CBD <0.5%), B (THC 8.6%, CBD 8.6%), C (THC 0.6%, CBD 14%) and placebo D (THC <0.3%, CBD <0.3%).

Three cannabis drug product formulations with different THC and CBD contents and placebo will be used in the following order: B (THC 8.6%, CBD 8.6%), placebo D (THC <0.3%, CBD <0.3%), A (THC 10%, CBD <0.5%), C (THC 0.6%, CBD 14%).

Three cannabis drug product formulations with different THC and CBD contents and placebo will be used in the following order: C (THC 0.6%, CBD 14%), A (THC 10%, CBD <0.5%), placebo D (THC <0.3%, CBD <0.3%), B (THC 8.6%, CBD 8.6%).

Three cannabis drug product formulations with different THC and CBD contents and placebo will be used in the following order: placebo D (THC <0.3%, CBD <0.3%), C (THC 0.6%, CBD 14%), B (THC 8.6%, CBD 8.6%), A (THC 10%, CBD <0.5%).

Outcomes

Primary Outcome Measures

Modified Rush Video-Based Tic Rating Scale
Can be used to assess changes in frequency and severity of tics

Secondary Outcome Measures

The Marijuana Effect Expectancy Questionnaire (MEEQ)
To assess tolerability of cannabis products

Full Information

First Posted
July 25, 2017
Last Updated
January 21, 2021
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03247244
Brief Title
Safety and Efficacy of Cannabis in Tourette Syndrome
Official Title
A Double-blind, Randomized, Placebo-controlled Crossover Pilot Trial of Medical Cannabis in Adults With Tourette Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Recruitment/enrollment took too long
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
June 6, 2019 (Actual)
Study Completion Date
January 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
For many individuals with Tourette syndrome (TS), available medications do not help with their symptoms, or cause significant side effects. Two small controlled trials have investigated the effect of oral delta-9-tetrahydrocannabinol (THC), a principal psychoactive ingredient of cannabis, in TS patients. While these trials have shown promising results, the effect sizes were not as large and consistent as those reported by patients with regards to inhaled cannabis (smoked or vaporized). Indeed, based on anecdotal evidence, patients have much greater improvement in their symptoms using inhaled cannabis than using cannabinoid pharmaceuticals. However, there have been no controlled trials of inhaled medical cannabis for TS to date. Furthermore, various medical cannabis products are authorized in Canada with different contents of THC and cannabidiol (CBD), another primary cannabinoid. No data exists regarding the dosing, efficacy and safety of these products in the treatment of TS. To gather such data, a double-blind, randomized, crossover pilot trial will be conducted to compare the efficacy and safety of three vaporized medical cannabis products with different THC and CBD contents, as well as placebo, in adults with TS. As well, the PK/PD profile of THC and CBD of the products will be assessed and correlated with tic symptoms

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome
Keywords
Cannabis, Tics, Tourette Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
There are four treatment schemes. All subjects will be randomized in a 1:1:1:1 ratio to one of the four treatment schemes. Participants will receive a single dose of each of the 3 cannabis products + placebo, with the order determine by their assigned treatment arm.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The participants, investigators and analysts will be masked as to the treatment arm and product of each participant and visit. Only the pharmacists will be aware of the strain.
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Three cannabis drug product formulations with different THC and CBD contents and placebo will be used in the following order: A (THC 10%, CBD <0.5%), B (THC 8.6%, CBD 8.6%), C (THC 0.6%, CBD 14%) and placebo D (THC <0.3%, CBD <0.3%).
Arm Title
2
Arm Type
Other
Arm Description
Three cannabis drug product formulations with different THC and CBD contents and placebo will be used in the following order: B (THC 8.6%, CBD 8.6%), placebo D (THC <0.3%, CBD <0.3%), A (THC 10%, CBD <0.5%), C (THC 0.6%, CBD 14%).
Arm Title
3
Arm Type
Other
Arm Description
Three cannabis drug product formulations with different THC and CBD contents and placebo will be used in the following order: C (THC 0.6%, CBD 14%), A (THC 10%, CBD <0.5%), placebo D (THC <0.3%, CBD <0.3%), B (THC 8.6%, CBD 8.6%).
Arm Title
4
Arm Type
Other
Arm Description
Three cannabis drug product formulations with different THC and CBD contents and placebo will be used in the following order: placebo D (THC <0.3%, CBD <0.3%), C (THC 0.6%, CBD 14%), B (THC 8.6%, CBD 8.6%), A (THC 10%, CBD <0.5%).
Intervention Type
Drug
Intervention Name(s)
Cannabis
Other Intervention Name(s)
Marijuana
Intervention Description
THC 10%, CBD <0.5%
Intervention Type
Drug
Intervention Name(s)
Cannabis
Other Intervention Name(s)
Marijuana
Intervention Description
THC 8.6%, CBD 8.6%
Intervention Type
Drug
Intervention Name(s)
Cannabis
Other Intervention Name(s)
Marijuana
Intervention Description
THC 0.6%, CBD 14%
Primary Outcome Measure Information:
Title
Modified Rush Video-Based Tic Rating Scale
Description
Can be used to assess changes in frequency and severity of tics
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
The Marijuana Effect Expectancy Questionnaire (MEEQ)
Description
To assess tolerability of cannabis products
Time Frame
6 hours
Other Pre-specified Outcome Measures:
Title
Area under the plasma concentration versus time curve of CBD and 11-OH-THC
Description
Determine a temporal relationship between changes in THC/CBD plasma concentrations and tic severity
Time Frame
6 hours
Title
Premonitory Urge for Tics Scale (PUTS)
Description
Assesses the intensity of premonitory urges
Time Frame
1 hour
Title
Clinical Global Impression- Improvement Scale (CGI-I)
Description
Assesses how improved symptoms are after an intervention
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female adult, 18-65 years of age (inclusive) at the time of signing the informed consent. The subject meets current DSM-5 diagnostic criteria for TS[6], diagnosed by a neuropsychiatrist with expertise in TS and related conditions. YGTSS-TTS ≥16, frequency subscore = 5 and intensity subscore ≥ 2. In addition, tic free intervals do not last more than two minutes based on both self-reporting and observation by clinician at both screening and Week 0 (randomization). This requirement is for the purpose of minimizing the potential for floor effects given the relatively short window for assessing effect on symptoms in this single-dose trial. The subject is able and willing to refrain from using any non-study cannabis during the screening and treatment phases of the study. Females of childbearing potential (defined by menarche and not having undergone surgical sterilization/hysterectomy) must have a negative pregnancy test, must be practicing acceptable double-barrier methods of contraception (or can confirm abstinence at each scheduled visit), and must not be breast feeding. Written informed consent must be obtained from the subject prior to the initiation of any protocol-required procedures. The subject is able to comprehend and satisfactorily comply with the protocol requirements. Exclusion Criteria: • The subject and/or his/her family have a history of psychosis, schizophrenia or bipolar disorder. Sexually active females of childbearing potential who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial; Females who are breast-feeding and/or who have a positive serum pregnancy test result prior at the time of screening. The subject represents a significant risk of committing suicide (current suicide plan or attempt in past 2 years) or committing homicide. The subject has a history of serious head injury, seizure disorder, or developmental delay (intelligence quotient≤85). The subject has either of: cardiovascular disease; respiratory disease such as chronic obstructive pulmonary disease (COPD) or lung cancer (asthma is not an exclusionary criterion); hepatitis. The subject has a current or past history of substance abuse within the last 5 years, with the exception of cannabis. The subject is using cannabis regularly for the treatment of TS. The subject has any abnormal laboratory tests and vital sign results which in the investigator's judgment is medically significant and would impact the safety of the subject or the interpretation of the study results.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Sandor, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital - Tourette Syndrome Neurodevelopmental Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T2S8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
36040329
Citation
Abi-Jaoude E, Bhikram T, Parveen F, Levenbach J, Lafreniere-Roula M, Sandor P. A Double-Blind, Randomized, Controlled Crossover Trial of Cannabis in Adults with Tourette Syndrome. Cannabis Cannabinoid Res. 2022 Aug 30. doi: 10.1089/can.2022.0091. Online ahead of print.
Results Reference
derived

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Safety and Efficacy of Cannabis in Tourette Syndrome

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