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SciSparc Secures FDA Green Light to US Launch of its Pivotal Phase IIb Clinical Trial for Breakthrough Tourette Syndrome Treatment
SciSparc (Nasdaq: SPRC) has received FDA approval to proceed with its Phase IIb clinical trials in the U.S. for SCI-110, a potential breakthrough treatment for Tourette Syndrome (TS) in adults. This approval comes just one month after the application submission, marking a significant milestone for the company. The trial will be conducted at three leading centers: Yale Child Study Center, Hannover Medical School, and Tel Aviv Sourasky Medical Center.
The study aims to evaluate the efficacy, safety, and tolerability of SCI-110 in adult patients aged 18-65 years. 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. SciSparc's CEO, Oz Adler, emphasized the unmet medical need for TS management and highlighted the promising results from their Phase IIa trial, which showed an average tic reduction of 21% across the entire sample.
The study aims to evaluate the efficacy, safety, and tolerability of SCI-110 in adult patients aged 18-65 years. 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. SciSparc's CEO, Oz Adler, emphasized the unmet medical need for TS management and highlighted the promising results from their Phase IIa trial, which showed an average tic reduction of 21% across the entire sample.
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