The Israeli Ministry of Health has granted approval for SciSparc to conduct the Phase IIb clinical trial of SCI-110 to treat Tourette Syndrome in adult patients.
The placebo controlled, randomised, cross-over, double-blind trial will assess the safety, tolerability, and efficacy of daily oral SCI-110 in adult patients aged between 18 and 65 years with Tourette Syndrome.
In the trial, the participants will be randomised in a 1:1 ratio and be given either SCI-110 or a SCI-110 matched placebo.
The trial’s primary efficacy objective is to evaluate tic severity change using the Yale Global Tic Severity Scale as a continuous endpoint at weeks 12 and 26, compared to baseline.
Absolute and relative frequencies of serious adverse events will be assessed for all the participants in the trial and separately for the SCI-110 and placebo groups as the trial’s primary safety objective.
The Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, is the first clinical site to receive approval to conduct the trial.
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SciSparc is also planning to conduct the trial in many sites including the Yale Child Study Center, the Yale School of Medicine in Connecticut, US, and Hannover Medical School in Hannover, Germany.
SciSparc CEO Oz Adler said: “This is another step for the company’s progress in the developments of much needed treatment for Tourette Syndrome.
“We are proud to be able to collaborate with centres of excellence around the world such as Yale University, Hannover Medical School, and the Tel Aviv Sourasky Medical Center.
“Based on previous results from our Phase IIa trial conducted at the same site at Yale University, we believe our proprietary SCI-110 treatment has the potential to help Tourette Syndrome patients around the world.”
The company noted that the launch of the clinical trial at Yale University is subject to the receipt of approval from the US Food and Drug Administration and Yale University’s institutional review boards.
The launch of the trial at Hannover Medical School is subject to approval from the German Federal Institute for Drugs and Medical Devices.