Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents With FXS
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03802799
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 476 participants
Conditions and interventions
Conditions
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 9, 2018 (Actual)
- Primary completion
- Jun 30, 2026 (Estimated)
- Completion
- Jun 30, 2026 (Estimated)
- Last update posted
- May 27, 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 27, 2026 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03802799 live on ClinicalTrials.gov.