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Clinical Trials in the USA / NCT03802799
Active, not recruiting Phase 2/3

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

NCT03802799 · tracked via the Priya Life Science USA tracker
Sponsor
Zynerba Pharmaceuticals, Inc.
Phase
Phase 2/3
Started
2018-11-09
Last updated
2026-05-27

Condition(s) studied

Fragile X Syndrome

Investigational drug(s) / intervention(s)

ZYN002 - Cannabidiol Transdermal Gel

ZYN002 - Cannabidiol Transdermal Gel: Pharmaceutically manufactured. Cannabidiol formulated as a clear gel (transdermal delivery)

Study 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.

Eligibility

Sex
ALL
Min age
3 Years
Max age
29 Years
Healthy volunteers
No
Inclusion Criteria: * Participated in study ZYN2-CL-016 or Study ZYN2-CL-033. * Patients and parents/caregivers agree to abide by all study restrictions and comply with all study procedures. * Patients and parents/caregivers must be adequately informed of the nature, risks of the study, and give written informed consent prior to enrollment in ZYN2-CL-017. * In the Investigator's opinion, the patients and parents/caregivers are reliable and are willing and able to comply with all protocol requirements and procedures. * Females of childbearing potential must have a negative pregnancy test at all designated visits Exclusion Criteria: * Patient is receiving any investigational drugs (not ZYN002) or using any experimental devices. * Patient has an ongoing serious adverse event (SAE) or has experienced a SAE in ZYN2-CL-016 or ZYN2-CL-033, which in the opinion of the Investigator, should exclude them from participation. * Females who are pregnant, nursing, or planning a pregnancy; females of childbearing potential and male patients with a partner of childbearing potential who are unwilling or unable to use an acceptable method of contraception for the duration of therapy and for three months after the last dose of trial drug. * Patients who have alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels ≥ 2 times the upper limit of normal (ULN) or has alkaline phosphatase levels ≥ 3 times the ULN as determined from patient safety laboratories.

Primary outcome measure(s)

Trial sites (26)

FacilityCityRegionStatus
Southwest Autism Research and Resource Center Phoenix Arizona
Science 37 Culver City California
Amnova Clinical Research, LLC Irvine California
UC Davis Health System, MIND Institute Sacramento California
Children's Hospital of Colorado Denver Colorado
Children's Research Institute Washington D.C. District of Columbia
University of Miami Miami Florida
Han Phan Atlanta Georgia
Rush University Medical Center Chicago Illinois
Kennedy Krieger Institute Baltimore Maryland
Boston Children's Hospital Boston Massachusetts
Masonic Institute of Developing Brain Minneapolis Minnesota
University of Mississipi Medical Center Jackson Mississippi
The Fragile X Spectrum Disorder Clinic at Icahn School of Medicine at Mount Sinai, Division of Medical Genetics New York New York
Cincinnati Children's Hospital Medical Center Cincinnati Ohio
Central States Research Tulsa Oklahoma
Penn State Milton S. Hershey Medical Center Hershey Pennsylvania
Greenwood Genetic Center Greenville South Carolina
Primary Children's Hospital Salt Lake City Utah
Westmead Children's Hospital Sydney New South Wales
Lady Cilento Children's Hospital - South Brisbane Brisbane Queensland
Genetics Clinics Australia Melbourne Victoria
Wellington Hospital Wellington New Zealand
Research Space Leicester Leicestershire
Children's Clinical Research Facility, Royal Hospital for Children and Young People Edinburgh Lothian
Manchester University NHS Foundation Trust Manchester United Kingdom

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03802799 on ClinicalTrials.gov ↗ ← All trials in the USA