SCI-110 for Tourette Syndrome

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byKirsten R Müller-Vahl, PhD. MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: SciSparc

Prior Safety Data

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.

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.

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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.

See 13 more

Treatment Details

Interventions

Placebo (Other)
SCI-110 (Cannabinoid-based medication)

Trial OverviewThe 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

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