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CBD gel tested for Long-Term safety in fragile x kids and young adults

NCT ID NCT03802799

Disease control Sponsor: Zynerba Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at the long-term safety of a CBD gel (ZYN002) applied to the skin for children, teens, and young adults with Fragile X syndrome. Participants from two earlier studies will use the gel twice daily for 52 weeks. The main goal is to check for side effects, with a secondary focus on whether symptoms improve.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cannabidiol (CBD) gel applied to the skin
What this could lead to
If successful, this could show that daily CBD gel is safe and may help manage symptoms of Fragile X syndrome over the long term.
What could go wrong
This is an extension study, not a new treatment test. It focuses on safety, not proof of effectiveness. Results may not apply to everyone with Fragile X.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

476 people

The number who actually took part.

Started

Nov 2018

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 29 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

fragile X syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fragile X syndrome

Contacts and locations

Locations

  • Amnova Clinical Research, LLC

    Irvine, California, 92604, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Central States Research

    Tulsa, Oklahoma, 74136, United States

  • Children's Clinical Research Facility, Royal Hospital for Children and Young People

    Edinburgh, Lothian, EH105HF, United Kingdom

  • Children's Hospital of Colorado

    Denver, Colorado, 80045, United States

  • Children's Research Institute

    Washington D.C., District of Columbia, 20010, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Genetics Clinics Australia

    Melbourne, Victoria, 3161, Australia

  • Greenwood Genetic Center

    Greenville, South Carolina, 29605, United States

  • Han Phan

    Atlanta, Georgia, 30329, United States

  • Kennedy Krieger Institute

    Baltimore, Maryland, 21205, United States

  • Lady Cilento Children's Hospital - South Brisbane

    Brisbane, Queensland, 4101, Australia

  • Manchester University NHS Foundation Trust

    Manchester, M13 9WL, United Kingdom

  • Masonic Institute of Developing Brain

    Minneapolis, Minnesota, 55414, United States

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113, United States

  • Research Space

    Leicester, Leicestershire, LE15WW, United Kingdom

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Science 37

    Culver City, California, 90230, United States

  • Southwest Autism Research and Resource Center

    Phoenix, Arizona, 85006, United States

  • The Fragile X Spectrum Disorder Clinic at Icahn School of Medicine at Mount Sinai, Division of Medical Genetics

    New York, New York, 10029, United States

  • UC Davis Health System, MIND Institute

    Sacramento, California, 95817, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Mississipi Medical Center

    Jackson, Mississippi, 39216, United States

  • Wellington Hospital

    Wellington, 6021, New Zealand

  • Westmead Children's Hospital

    Sydney, New South Wales, 2145, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.