Clinical Study of Cannabidiol in Children, Adolescents, and Young Adults With Fragile X Syndrome

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

215

Participants

Timeline

Start Date

September 13, 2021

Primary Completion Date

May 31, 2025

Study Completion Date

May 31, 2025

Conditions
Fragile X Syndrome
Interventions
DRUG

ZYN002 - transdermal gel

Pharmaceutically manufactured cannabidiol formulated as a clear gel that can be applied to the skin (transdermal delivery)

DRUG

Placebo

"Placebo formulated as a clear gel that can be applied to the skin (transdermal delivery)~Other Names:~Placebo Comparator Matching Placebo"

Trial Locations (27)

2145

Westmead Children's Hospital, Sydney

3161

Genetics Clinics Australia, Melbourne

4101

Lady Cilento Children's Hospital - South Brisbane, Brisbane

6021

Health New Zealand - Te Whatu Ora - Wellington Hospital, Newtown

10029

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

17033

Penn State Hershey Medical Center, Hershey

20010

Children's National Medical center, Washington D.C.

21205

Kennedy Krieger Institute, Baltimore

29605

Greenwood Genetic Center, Greenville

30318

Rare Disease Research, Atlanta

33136

University of Miami, Miami

39216

University of Mississippi, Jackson

55454

University of Minnesota Fragile X Clinic (Voyager Clinic), Minneapolis

60612

Rush University Medical Center, Chicago

74136

Central States Research, Tulsa

84113

Primary Children's Hospital, Salt Lake City

85016

Phoenix Children's Hospital, Phoenix

90230

Science 37, Culver City

92604

Amnova Clinical Research, LLC, Irvine

92868

Thompson Autism Center CHOC, Orange

95817

UC Davis Health System, MIND Institute, Sacramento

02115

Boston Children's Hospital, Boston

Unknown

Wellcome HRB Clinical Research Facility, Dublin

University of Edinburgh, Edinburgh

Leicester Clinical Research, Leicester

King's College, London

Manchester University NHS Foundation Trust, Manchester

All Listed Sponsors
lead

Zynerba Pharmaceuticals, Inc.

INDUSTRY