Status:
TERMINATED
Safety and Efficacy of Cannabis in Tourette Syndrome
Lead Sponsor:
University Health Network, Toronto
Conditions:
Tourette Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- • 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.
Key Trial Info
Start Date :
January 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03247244
Start Date
January 15 2018
End Date
January 27 2020
Last Update
January 25 2021
Active Locations (1)
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1
Toronto Western Hospital - Tourette Syndrome Neurodevelopmental Clinic
Toronto, Ontario, Canada, M5T2S8