SCI-110 for Tourette Syndrome

Recruiting at 2 trial locations

Overseen By Adi Zuloff-Shani, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: SciSparc

Must not be taking: Cannabis, Cannabinoid-based medicine

Disqualifiers: Severe psychiatric conditions, Substance abuse, Severe cardiac diseases, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

164 Participants Needed

Trial Summary

What is the purpose of this trial?

To evaluate the efficacy, safety and tolerability of the cannabinoid-based medication SCI-110 compared to placebo in subjects with Tourette syndrome.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications, but they must be on a stable dose for at least 6 weeks before the study and remain stable during the study.

How is the drug SCI-110 unique for treating Tourette Syndrome?

SCI-110 is unique because it is being tested in a clinical trial specifically for Tourette Syndrome, which often involves complex cases with multiple neuropsychiatric diagnoses. Unlike many existing treatments that are tested in highly selective samples, SCI-110 is part of a study design that may allow for a broader understanding of its effects in real-world conditions. ^{1 2 3 4 5}

Research Team

Kirsten R Müller-Vahl, PhD. MD

Principal Investigator

Hannover Medical School

Eligibility Criteria

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.

Inclusion Criteria

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 between 18 and 65 years old.

Exclusion 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.

I am currently receiving therapy for my tics.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily oral SCI-110 or placebo in a double-blind, cross-over design

12 weeks

Regular visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Regular visits for assessments

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

• Placebo
• SCI-110

Trial Overview 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).

Participant Groups

Group I: SCI-110 Experimental Treatment 1 Intervention

Cannabinoid-based medication consisting of Dronabinol and PEA

Group II: Dronabinol Placebo Group 1 Intervention

Placebo matched in taste, odour and appearance to SCI-110

Who Is Running the Clinical Trial?

SciSparc

Lead Sponsor

Trials

5

Recruited

330+

References

1. United States pubmed.ncbi.nlm.nih.gov

Assessment of scientific and ethical issues in two randomized clinical trial designs for patients with Tourette's syndrome: a model for studies of multiple neuropsychiatric diagnoses. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Risperidone as a treatment for Tourette's syndrome. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Mecamylamine in Tourette's syndrome: a two-year retrospective case study. [2013]

4. England pubmed.ncbi.nlm.nih.gov

A randomised, double-blind, placebo-controlled study of topiramate in the treatment of Tourette syndrome. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Influence of Tiapride and Topiramate on Tic Severity and Behavioral/Emotional Problems in Children with Tourette Syndrome: A Retrospective Study. [2023]