SciSparc has received approval from the institutional review board (IRB) of Yale University School of Medicine in the US to commence Phase IIb trials for SCI-110 in Tourette syndrome.
The Phase IIa trial for SCI-110 was also previously conducted at Yale.
Other sites for the randomised, multi-centre, placebo-controlled cross-over Phase IIb trial include the Hannover Medical School in Germany and the Tel Aviv Sourasky Medical Center in Israel.
Tourette syndrome is a neurological condition that causes a person to have ‘tics’, involuntary movements, and sounds. So far, there is no reported cure for the condition and according to the Centres for Disease Control and Prevention (CDC), only symptomatic treatment is accessible.
According to the Tourette Association of America, several trials have reported a reduction in tics with medical marijuana, synthetic tetrahydrocannabinol (THC). However, these have the potential for adverse effects.
SCI-110 contains Dronabinol, a synthetic THC, in combination with endocannabinoid palmitoylethanolamide (PEA) to augment Dronabinol’s effect. This can, in turn, reduce Dronabinol’s dosage and adverse effects.
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The primary objective of the Phase IIb trial is a decrease in the severity of ‘tics’, assessed at 12 and 26 weeks using the Yale Global Tic Severity Scale (YGTSS-R-TTS). The absolute and relative number of adverse events will also be assessed.
Emalex Biosciences reported positive Phase IIb data for the use of ecopipam in Tourette syndrome in January 2023 while Immune globulin (human) by Octapharma for Tourette’s is currently in Phase III clinical trials.