A Study to Investigate Behavioral and Other Co-Occurring Outcomes With Epidiolex as Add-On Therapy in Participants Aged 1 to 65 Years of Age With Tuberous Sclerosis Complex

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

79

Participants

Timeline

Start Date

June 29, 2023

Primary Completion Date

March 26, 2026

Study Completion Date

March 26, 2026

Conditions
Tuberous Sclerosis Complex Associated Neuropsychiatric Disease
Interventions
DRUG

Cannabidiol Oral Solution [Epidiolex]

100 mg/ml Cannabidiol Oral solution

Trial Locations (19)

22903

University of Virginia, Charlottesville, Charlottesville

27157

Atrium Health Wake Forest Baptist Medical Center, Winston-Salem

32608

University of Florida Health - Department of Neurology, Gainesville

33155

Nicklaus Children's Health, Miami, Miami

38103

Le Bonheur Children's Hospital, Memphis

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

55113

Minnesota Epilepsy Group, Roseville

77030

University of Texas Health Science Center at Houston - Clinical Research Unit, Houston

78229

University of Texas Health Science Center - San Antonio, San Antonio

80045

Children's Hospital Colorado, Aurora

06519

Yale University School of Medicine, New Haven

02114

Massachusetts General Hospital, Boston

T3B 6AB

Alberta Children's Hospital, Calgary

V6H 3V4

BC Children's Hospital, Vancouver

M5G 1X8

The Hospital for Sick Children, Toronto

04-736

The Children's Memorial Health Institute, Warsaw

SE1 7EH

Evelina London Children's Hospital Guys St Thomas' NHS Foundation Trust, the Guy's Hospital, London

BS1 3NU

University Hospitals Bristol NHS Foundation Trust, Bristol

2TH

Sheffield Children's NHS Foundation Trust, Sheffield

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY