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SCI-110 for Tourette Syndrome
Phase 2
Waitlist Available
Led By Kirsten R Müller-Vahl, PhD. MD
Research Sponsored by SciSparc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women of child-bearing potential must have a negative pregnancy test before first treatment with study medication and practice a highly effective, reliable and medically approved contraceptive regimen during the study
Male and female subjects with an age between ≥18 and ≤65 years
Must not have
Ongoing behavioural treatment for tics
Known severe cardiac diseases, known severe cardiovascular diseases, known positivity for human immunodeficiency virus (HIV), hepatitis C, hepatitis B, or other severe hepatic and renal disorders by history
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12 of each treatment period (visit 8 and 15).
Summary
This trial tests a cannabinoid-based medication to see if it helps people with Tourette Syndrome.
Who is the study for?
Adults aged 18-65 with Tourette Syndrome, having moderate to severe tics and a willingness to follow study procedures. Participants must have stable medication doses for at least 6 weeks prior and agree to maintain them during the trial. Women must not be pregnant or breastfeeding and use reliable contraception; men should use condoms.
What is being tested?
The trial is testing SCI-110, a cannabinoid-based medicine, against a placebo to see if it's effective, safe, and tolerable for treating Tourette Syndrome symptoms. Participants will randomly receive either SCI-110 or an inactive substance (placebo).
What are the potential side effects?
Possible side effects of SCI-110 may include dizziness, confusion, sedation or somnolence due to its cannabinoid content. Since it's cannabis-based, there might also be risks similar to those associated with cannabis use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant and will use effective birth control during the study.
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I am between 18 and 65 years old.
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I have been diagnosed with Tourette syndrome.
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I am a male willing to use a condom during the study and for three months after.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently receiving therapy for my tics.
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I do not have severe heart, liver, kidney diseases, HIV, or hepatitis.
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I am not allergic to cannabis, cannabinoids, or sesame oil.
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I have not used any experimental drugs or devices in the last 30 days.
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I have a chronic tic or other significant neurological disorder.
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My current medications have been stable for 6 weeks and don’t make me dizzy or sleepy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through out the study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through out the study
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Absolute change from baseline in revised version of Yale Global Tic Severity Scale -Revised - (YGTSS-R-TTS)
Secondary study objectives
Absolute change from baseline of YGTSS-R Total Score
Adult Tic Questionnaire (ATQ) Absolute Score
Adult Tic Questionnaire (ATQ) Percent Score
+26 moreOther study objectives
2.3. Suicide risk assessment measured by the Columbia-Suicide Severity Rating Scale (CSSRS)
Absolute values of vital sign blood pressure at each visit and change from baseline.
Absolute values of vital sign heart rate at each visit and change from baseline.
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SCI-110Experimental Treatment1 Intervention
Cannabinoid-based medication consisting of Dronabinol and PEA
Group II: DronabinolPlacebo Group1 Intervention
Placebo matched in taste, odour and appearance to SCI-110
Find a Location
Who is running the clinical trial?
SciSparcLead Sponsor
4 Previous Clinical Trials
167 Total Patients Enrolled
2 Trials studying Tourette Syndrome
77 Patients Enrolled for Tourette Syndrome
Kirsten R Müller-Vahl, PhD. MDPrincipal InvestigatorHannover Medical School
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have used cannabis or cannabinoid-based medicine in the last 30 days.You have severe mental health conditions like developmental disability, psychotic illness, or bipolar disorder, as determined by the investigator.My medication and treatment for tics have been stable for 6 weeks, and I agree to keep them unchanged during the study.I am not pregnant and will use effective birth control during the study.I am currently receiving therapy for my tics.I do not have severe heart, liver, kidney diseases, HIV, or hepatitis.I am between 18 and 65 years old.You have OCD, ADHD, depression, or anxiety that is not well managed or needs to be adjusted for therapy according to the investigator's judgment.I am not allergic to cannabis, cannabinoids, or sesame oil.You have a current diagnosis of substance abuse or addiction.I have been diagnosed with Tourette syndrome.Your total tic score on the YGTSS-R is more than 14.You have a severe clinical global impression score of 4 or higher.I have not used any experimental drugs or devices in the last 30 days.I understand the risks and benefits of participating in this clinical study.I am a male willing to use a condom during the study and for three months after.You are pregnant according to a urine test.You have a history of being dependent on marijuana.I have a chronic tic or other significant neurological disorder.My current medications have been stable for 6 weeks and don’t make me dizzy or sleepy.
Research Study Groups:
This trial has the following groups:- Group 1: Dronabinol
- Group 2: SCI-110
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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