SciSparc To Conduct Clinical Trial For Dronabinol-Based Drug To Treat Tourette Syndrome In Germany

SciSparc Ltd. SPRC has been granted an approval from the Federal Institute for Drugs and Medical Devices in Germany (“BfArM”) for its phase IIb clinical trial to use SCI-110 for treating adults with Tourette syndrome at the Hannover Medical School in Hannover, Germany.

The phase IIb clinical trial will be conducted at three global leading centers of excellence: the Yale Child Study Center at the Yale School of Medicine in Connecticut, USA, the Hannover Medical School in Hannover, Germany, and at the Tel Aviv Sourasky Medical Center (“Sourasky”) in Tel Aviv, Israel. The company has already secured the Institutional Review Board approvals from all three clinical sites as well as the Israeli Ministry of Health's approval for the clinical trial at Sourasky.

Authorization from the BfArM has been granted on the condition that some additional information for the release and stability of SCI-110 will be provided within 90 days.

The objective of this clinical trial is to evaluate the efficacy, safety and tolerability of SciSparc's proprietary drug candidate SCI-110 in adult patients (between 18 and 65 years of age) using a daily oral treatment. The patients will be randomized in a 1:1 ratio to receive either SCI-110 or a SCI-110-matched placebo. The primary efficacy objective of the study will be to assess tic severity change using the Yale global tic severity scale, the most commonly used measure in clinical trials of this kind, as a continuous endpoint at week 12 and week 26 of the double-blind phase compared to baseline. The primary safety objective of the study will be to assess absolute and relative frequencies of serious adverse events for the entire population and, separately, for the SCI-110 and placebo groups.

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Photo by Louis Reed on Unsplash

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