SciSparc
To evaluate the efficacy, safety and tolerability of the cannabinoid-based medication SCI-110 compared to placebo in subjects with Tourette syndrome.
Tourette Syndrome
SCI-110
Placebo
Phase 2
It is believed that SCI-110 will be a valuable treatment option, especially for t those subjects with TS, who do not benefit from or do not tolerate first-line treatment with antipsychotics. Since there is evidence that currently available CBM improves not only tics, but also psychiatric comorbidities, SCI-110 might be even more beneficial to improve a broader spectrum of symptoms resulting in both improved quality of life and decreased disease related costs. Moreover, PEA was shown to minimize AEs associated with cannabinoids use and to reduce their required effective dose (data not published). Hence, the use of SCI-110 is expected to show a therapeutic effect superior to currently available CBMs. It can be assumed that AEs in TS subjects do not differ from AEs described in other groups of subjects treated with medicinal cannabis and/or cannabinoids. In general, cannabinoids are considered as well tolerated.}}
Study Type : | Interventional |
Estimated Enrollment : | 164 participants |
Masking : | Quadruple |
Primary Purpose : | Treatment |
Official Title : | A Randomized, Double-Blind, Placebo Controlled, Cross-Over Study to Evaluate the Efficacy, Safety and Tolerability of Daily Oral SCI-110 in Treating Adults With Tourette Syndrome. |
Actual Study Start Date : | February 2024 |
Estimated Primary Completion Date : | August 2025 |
Estimated Study Completion Date : | December 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: SCI-110 Cannabinoid-based medication consisting of Dronabinol and PEA |
Drug: SCI-110 |
Placebo Comparator: Dronabinol Placebo matched in taste, odour and appearance to SCI-110 |
Other: Placebo |
Ages Eligible for Study: | 18 Years to 65 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Yale Child Study Center - NIHB 205
New Haven, Connecticut, United States, 06519
Not yet recruiting
Hannover Medical School
Hannover, Germany, 30625
Not yet recruiting
Neurological Institute, Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239