Tourette Syndrome Clinical Trial
Official title:
A Randomized Double Blind Placebo Controlled Proof of Concept Study to Evaluate Safety, Tolerability and Efficacy of Daily Oral THX-110 in Treating Adults With Tourette Syndrome ("Entourage")
This study evaluates the efficacy and safety of THX-110 in the management of tics and other symptoms (e.g. rage attacks, anxiety, depression, sleep difficulties) in patients with Tourette syndrome. In the first part of the study, half of the patients will receive THX-110, while the other half will receive a placebo. After completion of the first study part, patients will have the opportunity to continue into the second part of the study. In this part, all participants will receive THX-110.
THX-110 is an investigational drug and is being developed for the treatment of patients with
Tourette syndrome and other conditions. THX-110 consists of an active substance from cannabis
(dronabinol, tetrahydrocannabinol, THC) and PEA, a substance that occurs naturally in the
human body, in animals and plants.
Dronabinol and similar active substances are already approved in some countries for the
treatment of other conditions. In some countries, various cannabis-based medications are
currently being used in the treatment of patients with Tourette syndrome, mostly without
official approval.
PEA has already been used and well tolerated in numerous clinical trials. The combination of
PEA and dronabinol is assumed to show better efficacy compared to treatment with dronabinol
alone.
The planned study will evaluate the efficacy of THX-110 in the management of tics and other
symptoms in patients with Tourette syndrome. Other objectives are to assess study drug dosage
and to identify side effects that may be associated with the study drug.
In the first part of the study, half of the patients will receive THX-110, while the other
half will receive a placebo. The treatment phase will last 12 weeks. After completion of the
first part, patients can decide if they want to participate in the second part of the study.
In this optional second part of the study, all patients will receive THX-110 for 12 weeks.
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