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

ClinicalTrials.gov ID: NCT03802799

Public ClinicalTrials.gov record NCT03802799. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Jul 23, 2026, 6:18 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Study identification

NCT ID: NCT03802799
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Phase 2, Phase 3
Lead sponsor: Zynerba Pharmaceuticals, Inc.; Industry
Enrollment: 476 participants

Conditions and interventions

Conditions

Fragile X Syndrome

Interventions

ZYN002 - Cannabidiol Transdermal Gel Drug

Drug

Eligibility (public fields only)

Age range: 3 Years to 29 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 8, 2018
Primary completion: Jun 29, 2026
Completion: Jun 29, 2026
Last update posted: May 26, 2026

2018 – 2026

United States locations

U.S. sites: 19
U.S. states: 17
U.S. cities: 19

Facility	City	State	ZIP	Site status
Southwest Autism Research and Resource Center	Phoenix	Arizona	85006	—
Science 37	Culver City	California	90230	—
Amnova Clinical Research, LLC	Irvine	California	92604	—
UC Davis Health System, MIND Institute	Sacramento	California	95817	—
Children's Hospital of Colorado	Denver	Colorado	80045	—
Children's Research Institute	Washington D.C.	District of Columbia	20010	—
University of Miami	Miami	Florida	33136	—
Han Phan	Atlanta	Georgia	30329	—
Rush University Medical Center	Chicago	Illinois	60612	—
Kennedy Krieger Institute	Baltimore	Maryland	21205	—
Boston Children's Hospital	Boston	Massachusetts	02115	—
Masonic Institute of Developing Brain	Minneapolis	Minnesota	55414	—
University of Mississipi Medical Center	Jackson	Mississippi	39216	—
The Fragile X Spectrum Disorder Clinic at Icahn School of Medicine at Mount Sinai, Division of Medical Genetics	New York	New York	10029	—
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	45229	—
Central States Research	Tulsa	Oklahoma	74136	—
Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania	17033	—
Greenwood Genetic Center	Greenville	South Carolina	29605	—
Primary Children's Hospital	Salt Lake City	Utah	84113	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03802799, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 26, 2026 · Synced Jul 23, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03802799 live on ClinicalTrials.gov.

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