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