Clinical Study Of caNNabidiol in childrEn and adolesCenTs With Fragile X (CONNECT-FX)
Public ClinicalTrials.gov record NCT03614663. 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 and Adolescents With Fragile X Syndrome
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This trial will evaluate the efficacy and safety of ZYN002, a clear cannabidiol gel that can be applied to the skin (called transdermal application) twice a day for the treatment of behavioral symptoms of Fragile X Syndrome (FXS). Eligible participants will then participate in up to a 14 week treatment period, where all participants will receive placebo or active study drug. Patients ages 3 to \< 18 years, will be eligible to participate.
Study identification
- NCT ID
- NCT03614663
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 212 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 3 Years to 17 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
- Jun 12, 2018 (Actual)
- Primary completion
- Jun 14, 2020 (Actual)
- Completion
- Jun 14, 2020 (Actual)
- Last update posted
- Jul 6, 2022
2018 – 2020
United States locations
- U.S. sites
- 17
- U.S. states
- 15
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southwest Autism Research and Resource Center | Phoenix | Arizona | 85006 | — |
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | — |
| UC Davis Health System, MIND Institute | Sacramento | California | 95817 | — |
| Children's Hospital of Colorado | Denver | Colorado | 80045 | — |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Kennedy Krieger Institute | Baltimore | Maryland | 21205 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| Fragile X Center of Atlantic Health System | Morristown | New Jersey | 07960 | — |
| The Fragile X Spectrum Disorder Clinic at Icahn School of Medicine at Mount Sinai, Division of Medical Genetics | New York | New York | 10029 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27510 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Central States Research | Tulsa | Oklahoma | 74136 | — |
| Suburban Research Associates | Media | Pennsylvania | 19063 | — |
| Greenwood Genetic Center | Greenville | South Carolina | 29605 | — |
| University of Washington Center for Human Development and Disability | Seattle | Washington | 98198 | — |
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 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03614663, 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 Jul 6, 2022 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03614663 live on ClinicalTrials.gov.