Clinical Study of Cannabidiol in Children, Adolescents, and Young Adults With Fragile X Syndrome
Public ClinicalTrials.gov record NCT04977986. 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
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children, Adolescents and Young Adults With Fragile X Syndrome - RECONNECT
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a randomized, double-blind, placebo-controlled, multiple-center study, to assess the efficacy and safety of cannabidiol administered as ZYN002 for the treatment of children, adolescent, and young adult patients with Fragile X syndrome (FXS). Eligible participants will participate in up to an 18-week treatment period, where all participants will receive placebo or active study drug. Patients ages 3 to \< 30 years will be eligible to participate.
Study identification
- NCT ID
- NCT04977986
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 257 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
- Sep 12, 2021
- Primary completion
- Aug 28, 2025
- Completion
- Aug 28, 2025
- Last update posted
- Aug 31, 2026
2021 – 2025
United States locations
- U.S. sites
- 18
- U.S. states
- 15
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | — |
| Science 37 | Culver City | California | 90230 | — |
| Amnova Clinical Research, LLC | Irvine | California | 92604 | — |
| Thompson Autism Center CHOC | Orange | California | 92868 | — |
| UC Davis Health System, MIND Institute | Sacramento | California | 95817 | — |
| Children's National Medical center | Washington D.C. | District of Columbia | 20010 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Rare Disease Research | Atlanta | Georgia | 30318 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Kennedy Krieger Institute | Baltimore | Maryland | 21205 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| University of Minnesota Fragile X Clinic (Voyager Clinic) | Minneapolis | Minnesota | 55454 | — |
| University of Mississippi | 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 | — |
| Central States Research | Tulsa | Oklahoma | 74136 | — |
| Penn State 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 9 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04977986, 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 Aug 31, 2026 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04977986 live on ClinicalTrials.gov.