Clinical Study of Cannabidiol in Children, Adolescents, and Young Adults With Fragile X Syndrome

Summary

This is a randomized, double-blind, placebo-controlled, multiple-center study, to assess the efficacy and safety of cannabidiol administered as ZYN002 for the treatment of children, adolescent, and young adult patients with Fragile X syndrome (FXS). Eligible participants will participate in up to an 18-week treatment period, where all participants will receive placebo or active study drug. Patients ages 3 to \< 30 years will be eligible to participate.

Timeline

Start

2021-09-13

Primary completion

2025-08-29

Completion

2025-08-29

Outcome

Missed primary endpoint

release “The RECONNECT Study did not meet the primary endpoint of improvement in social avoidance primarily due to a higher than expected placebo response rate.” harmonybiosciences.com ↗

Drugs

Indications