Active not recruitingPHASE2, PHASE3INTERVENTIONAL

Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents With FXS

At a glance

Status

Active not recruiting

Phase

PHASE2, PHASE3

Sponsor

Zynerba Pharmaceuticals, Inc.

Enrolment target

476

Start

09 Nov 2018

Estimated completion

30 Jun 2026

Fragile X Syndrome

What is this study about?

ZYN002 is a pharmaceutically manufactured Cannabidiol that is developed as a clear gel that can be applied to the skin (called transdermal delivery).

The gel will be applied to clean, dry, intact skin of the shoulders and/or upper arms.

Participants from the ZYN2-CL-016 and ZYN2-CL-033 studies who meet the inclusion criteria and none of the exclusion criteria for study ZYN2-CL-017 are eligible.

Parents/caregivers will apply the study gel twice daily for the 52-week treatment period.

Who may be eligible?

Age 3 Years to 29 Years · Sex: ALL

Locations (26)

Southwest Autism Research and Resource Center
Phoenix, United States
Science 37
Culver City, United States
Amnova Clinical Research, LLC
Irvine, United States
UC Davis Health System, MIND Institute
Sacramento, United States
Children's Hospital of Colorado
Denver, United States
Children's Research Institute
Washington D.C., United States
University of Miami
Miami, United States
Han Phan
Atlanta, United States
Rush University Medical Center
Chicago, United States
Kennedy Krieger Institute
Baltimore, United States
Boston Children's Hospital
Boston, United States
Masonic Institute of Developing Brain
Minneapolis, United States

+14 more sites — see the official record for the full list.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.