The movement and neurobehavioral disorder TS is characterised by motor and vocal tics and is associated with co-morbidities.
SCI-110 includes Dronabinol, which is the US Food and Drug Administration (FDA) approved synthetic form of THC, along with the endocannabinoid palmitoylethanolamide (PEA).
It is designed for cannabinoid receptors stimulation across the central nervous system and for inhibiting endocannabinoids metabolic degradation to enhance THC uptake.
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The study is being carried out under the regulation of the US Food and Drug Administration (FDA), the Israeli Ministry of Health, and the Federal Institute for Drugs and Medical Devices in Germany.
The company commenced the study at the Tel Aviv Sourasky Medical Center and is anticipated to continue with its medical sites in Germany and the US.
It already received institutional review board approval from all three clinical sites besides approval from the Israeli Ministry of Health for the clinical study at Sourasky and BfArM to carry out the trial at the Hannover Medical School.
The trial’s objective is to assess the safety, efficacy and tolerability of SCI-110 in adult subjects aged between 18 and 65 years utilising a daily treatment orally.
It will randomise the patients into a 1:1 ratio to receive either SCI-110 or a matched placebo.
Assessing tic severity change using the Yale Global Tic Severity Scale as a continuous endpoint at week 12 and week 26 of the double-blind phase against baseline is the trial’s primary efficacy objective.
Furthermore, its primary safety objective is to evaluate absolute and relative frequencies of serious adverse events for all the subjects and, separately, for the groups receiving SCI-110 and placebo.