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SciSparc Submitted IND Application to the FDA for SCI-110 Phase IIb Clinical Trial for Patients with Tourette Syndrome
SciSparc (Nasdaq: SPRC) has submitted an Investigational New Drug (IND) application to the FDA for its phase IIb clinical trial of SCI-110, a potential treatment for Tourette Syndrome (TS). The trial will be conducted at three leading centers: Yale Child Study Center, Hannover Medical School, and Tel Aviv Sourasky Medical Center. SCI-110, composed of dronabinol and palmitoylethanolamide, aims to address challenges in current TS treatments.
The study will evaluate the efficacy, safety, and tolerability of SCI-110 in adult patients aged 18-65. Participants will be randomized to receive either SCI-110 or a placebo. The primary efficacy objective is to assess tic severity change using the Yale Global Tic Severity Scale at weeks 12 and 26 compared to baseline. The trial's primary safety objective is to assess the frequency of serious adverse events.
The study will evaluate the efficacy, safety, and tolerability of SCI-110 in adult patients aged 18-65. Participants will be randomized to receive either SCI-110 or a placebo. The primary efficacy objective is to assess tic severity change using the Yale Global Tic Severity Scale at weeks 12 and 26 compared to baseline. The trial's primary safety objective is to assess the frequency of serious adverse events.
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