drugset / Trial / NCT04977986

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

NCT04977986

Phase 3 Completed 215 enrolled Zynerba Pharmaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Cannabidiol Other / unclassified Other

Indications