Clinical Study Of caNNabidiol in childrEn and adolesCenTs With Fragile X (CONNECT-FX)

Exclusion Criteria

• •Females who are pregnant, nursing or planning a pregnancy.
• •Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin levels greater than or equal to 2 times the upper limit of normal or alkaline phosphatase levels greater than or equal to 3 times the upper limit of normal.
• •Use of a strong inhibitor/inducer of CYP3A4 or sensitive substrate of CYP3A4.
• •Use of minocycline for 30 days prior to screening or throughout the study.
• •Use of any benzodiazepine at screening or throughout the study.
• •Use of THC or CBD-containing product within three months of Screening Visit or during the study.
• •Change in pharmacologic or non-pharmacologic intervention during the course of the study.
• •Any skin disease or condition including eczema, psoriasis, melanoma, acne, contact dermatitis, scarring, imperfections, lesions, tattoos, or discoloration that may affect treatment application, application site assessments or absorption of the trial drug.
• •Patient is using the following ASMs: clobazam, phenobarbital, ethosuximide, felbamate or vigabatrin.
• •Patients has an advanced, severe or unstable disease that may interfere with the study outcome evaluations.
• •Patient has acute or progressive neurological disease, psychosis, schizophrenia or any other psychiatric disorder or severe mental abnormalities (other than FXS) that are likely to require changes in drug therapy or interfere with the study objectives or ability to adhere to protocol requirements.
• •Patient has suspected or confirmed cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, cardiac conduction problems, exercise-related cardiac events including syncope and pre-syncope, risk factors for Torsades de pointes (e.g. heart failure, hypokalemia, family history of Long QT Syndrome) or other serious cardiac problems.
• •History of treatment for, or evidence of drug abuse within the past year.
• •Patient responds "yes" to Question 4 or 5 on the C-SSRS (Children) during Screening or at any time on study.