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Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents With FXS
Sponsor: Zynerba Pharmaceuticals, Inc.
Summary
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.
Official title: An Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of ZYN002 Administered as a Transdermal Gel to Children, Adolescents, and Young Adults With Fragile X Syndrome
Key Details
Gender
All
Age Range
3 Years - 29 Years
Study Type
INTERVENTIONAL
Enrollment
550
Start Date
2018-11-09
Completion Date
2027-08-31
Last Updated
2025-11-05
Healthy Volunteers
No
Conditions
Interventions
ZYN002 - Cannabidiol Transdermal Gel
Pharmaceutically manufactured. Cannabidiol formulated as a clear gel (transdermal delivery)
Locations (26)
Southwest Autism Research and Resource Center
Phoenix, Arizona, United States
Science 37
Culver City, California, United States
Amnova Clinical Research, LLC
Irvine, California, United States
UC Davis Health System, MIND Institute
Sacramento, California, United States
Children's Hospital of Colorado
Denver, Colorado, United States
Children's Research Institute
Washington D.C., District of Columbia, United States
University of Miami
Miami, Florida, United States
Han Phan
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Kennedy Krieger Institute
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Masonic Institute of Developing Brain
Minneapolis, Minnesota, United States
University of Mississipi Medical Center
Jackson, Mississippi, United States
The Fragile X Spectrum Disorder Clinic at Icahn School of Medicine at Mount Sinai, Division of Medical Genetics
New York, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Central States Research
Tulsa, Oklahoma, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Greenwood Genetic Center
Greenville, South Carolina, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Westmead Children's Hospital
Sydney, New South Wales, Australia
Lady Cilento Children's Hospital - South Brisbane
Brisbane, Queensland, Australia
Genetics Clinics Australia
Melbourne, Victoria, Australia
Wellington Hospital
Wellington, New Zealand
Research Space
Leicester, Leicestershire, United Kingdom
Children's Clinical Research Facility, Royal Hospital for Children and Young People
Edinburgh, Lothian, United Kingdom
Manchester University NHS Foundation Trust
Manchester, United Kingdom