SCI-110 in the Treatment of Tourette Syndrome
NCT05126888 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 164
Last updated 2026-04-21
Summary
To evaluate the efficacy, safety and tolerability of the cannabinoid-based medication SCI-110 compared to placebo in subjects with Tourette syndrome.
Conditions
- Tourette Syndrome
Interventions
- DRUG
-
SCI-110
SCI-110 - a softgel capsule containing Dronabinol and Palmitoylethanolamide (PEA) in the following doses: 2.5mg Dronabinol+400mg PEA, 5mg Dronabinol+400mg PEA and 10mg Dronabinol+400mg. Maximum dose 20mg Dronabinol and 800mg PEA a day.
- OTHER
-
Placebo
Pill that matches in taste, odour and appearance to SCI-110 active pills
Sponsors & Collaborators
-
Neurothera Labs Inc.
lead INDUSTRY
Principal Investigators
-
Kirsten R Müller-Vahl, PhD. MD · Hannover Medical School
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2027-10-31
- Completion
- 2028-02-29
- FDA Drug
- Yes
Countries
- United States
- Germany
- Israel
Study Locations
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