Hannover Medical School joins Yale Child Study Center and Tel Aviv Sourasky Medical Center in the adult study after German regulatory and ethics clearance.
NeuroThera Labs Inc. has opened a Phase IIb clinical trial site at Hannover Medical School in Hanover, Germany, for SCI-110, its proprietary cannabinoid-based treatment candidate for Tourette Syndrome in adults. The study had already received clearance from Germany’s Federal Institute for Drugs and Medical Devices (German medicines regulator) and Hannover Medical School’s ethics committee, allowing the program to move into its next stage at one of the trial’s key sites. SCI-110 combines dronabinol with palmitoylethanolamide in a single dosage form aimed at reducing tics and related symptoms while limiting side effects. The Phase IIb trial follows a Phase IIa study that showed an average tic reduction of 21% across the participant sample on the Yale Global Tic Severity Scale Total Tic Score. NeuroThera said the new study is randomized, double-blind, placebo-controlled and cross-over, with patients aged 18-65 assigned to SCI-110 or placebo and the primary endpoint measuring change in tic severity at weeks 12 and 26 versus baseline. Additional sites are planned at Yale Child Study Center in New Haven, Connecticut, and Tel Aviv Sourasky Medical Center in Tel Aviv, Israel.