a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, today announced it has received Institutional Review Board (IRB) approval for its Phase IIb clinical trial for SCI-110 in subjects suffering from Tourette Syndrome ("TS").
The objective of this Phase IIb randomized, multi-national, multi-center, double-blind, placebo controlled cross-over trial is to evaluate the efficacy, safety and tolerability of SciSparc's proprietary drug candidate SCI-110 in adults with TS (between 18 and 65 years of age).
The primary efficacy objective of the trial will be to assess tic severity change using the Yale Global Tic Severity Scale (YGTSS-R-TTS), the most commonly used measure in clinical trials, as a continuous endpoint at week 12 and week 26 of the double-blind phase compared to baseline. The primary safety objective of the trial 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.
The trial will be led by Dr. Michael H. Bloch, M.D., M.S., an associate professor in the Child Study Center at Yale University School of Medicine and a leading researcher in the field of TS. Yale is the third medical center to join SciSparc
