SciSparc Ltd. (NASDAQ:SPRC) ("Company" or "SciSparc"), today announced that its subsidiary NeuroThera Labs Inc. (TSXV:NTLX) ("NeuroThera"), a clinical-stage pharmaceutical company focused on developing novel treatments for central nervous system disorders, announced the initiation of its Phase IIb clinical trial site at  Hannover Medical School, Hanover, Germany ("MHH"), for SCI-110, its proprietary cannabinoid-based treatment candidate for Tourette Syndrome (TS) in adults.

The trial, which previously received regulatory clearance from Germany’s Federal Institute for Drugs and Medical Devices and MHH's ethics committee, is now advancing towards the next stage at Hannover Medical School, one of the key clinical sites of the study. SCI-110 combines dronabinol with the endocannabinoid-like palmitoylethanolamide in an innovative one dosage form designed to reduce tics and comorbid symptoms in adults with TS while minimizing side effects.

In addition to Hannover Medical School, the trial will be conducted at Yale Child Study Center in New Haven, Connecticut, and Tel Aviv Sourasky Medical Center in Tel Aviv, Israel.

Building on the positive safety and efficacy results from the Phase IIa study, which showed an average tic reduction of 21% across the entire participants sample, as measured by the gold standard, Yale Global Tic Severity Scale Total Tic Score scale, the Phase IIb study is a randomized, double-blind, placebo-controlled, cross-over trial designed to evaluate the efficacy, safety, and tolerability of daily oral SCI-110. Patients aged 18-65 will be randomized to receive either SCI-110 or placebo, with the primary efficacy endpoint being the change in tic severity measured by the Yale Global Tic Severity Scale at weeks 12 and 26 compared to the baseline. Safety will be assessed through monitoring of adverse events.