Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents With FXS

PHASE2/PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

550

Participants

Timeline

Start Date

November 9, 2018

Primary Completion Date

August 31, 2027

Study Completion Date

August 31, 2027

Conditions
Fragile X Syndrome
Interventions
DRUG

ZYN002 - Cannabidiol Transdermal Gel

Pharmaceutically manufactured. Cannabidiol formulated as a clear gel (transdermal delivery)

Trial Locations (26)

2145

Westmead Children's Hospital, Sydney

3161

Genetics Clinics Australia, Melbourne

4101

Lady Cilento Children's Hospital - South Brisbane, Brisbane

6021

Wellington Hospital, Wellington

10029

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

17033

Penn State Milton S. Hershey Medical Center, Hershey

20010

Children's Research Institute, Washington D.C.

21205

Kennedy Krieger Institute, Baltimore

29605

Greenwood Genetic Center, Greenville

30329

Han Phan, Atlanta

33136

University of Miami, Miami

39216

University of Mississipi Medical Center, Jackson

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

55414

Masonic Institute of Developing Brain, Minneapolis

60612

Rush University Medical Center, Chicago

74136

Central States Research, Tulsa

80045

Children's Hospital of Colorado, Denver

84113

Primary Children's Hospital, Salt Lake City

85006

Southwest Autism Research and Resource Center, Phoenix

90230

Science 37, Culver City

92604

Amnova Clinical Research, LLC, Irvine

95817

UC Davis Health System, MIND Institute, Sacramento

02115

Boston Children's Hospital, Boston

LE15WW

Research Space, Leicester

EH105HF

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

M13 9WL

Manchester University NHS Foundation Trust, Manchester

All Listed Sponsors
lead

Zynerba Pharmaceuticals, Inc.

INDUSTRY