Clinical Trials

ASD Study (Soroka)

Evaluating the safety, tolerability and efficacy of SCI-210 in children with autism spectrum disorder.

Objective

Randomized

Study

evaluate the safety, tolerability and efficacy of SCI-210 in children with ASD in a randomized, double-blind, placebo-controlled crossover study.

Trial site

Clinical Research Center and Negev Autism Center, Soroka University Medical Center, Be’er Sheva, Israel.

Time

20 + 20

Weeks

20-week randomized, double-blind, placebo-controlled crossover trial of 60 children. 30 participants receive SCI-210 or SCI-210 placebo (CBD active, CannAmide™ placebo) for 20 weeks, followed by a 2-week washout and crossover for an additional 20 weeks.

Regulatory pathway

Phase III*

route

Designated Phase III* via the medical cannabis route.