Fragile X Syndrome Clinical Study

  • STATUS
    Recruiting
Updated on 22 December 2020
fragile x syndrome

Summary

This study will evaluate the efficacy and safety of ZYN002, a clear cannabidiol (CBD) gel that can be applied to the skin (called transdermal application) twice a day for the treatment of behavioral symptoms of Fragile X syndrome (FXS).

 

Description

For more information, please call as at 833-FXSTUDY or visit our study website

Details
Condition Fragile X Syndrome, Martin-Bell Syndrome, FXS Fragile X Martin Bell
Clinical Study IdentifierTX232166
Last Modified on22 December 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female children and adolescents aged 3 to less than 18 years, at the time of Screening
Diagnosis of FXS through molecular documentation of FMR1 full mutation
Judged to be in good health based on physical exam, 12-lead ECG and clinical laboratory test results
Patients must be assessed by the Investigator as being moderately to severely impacted due to FXS
Patients taking psychotropic medication(s) should be on a stable regimen of not more than two such medications for at least fours weeks preceding Screening and must maintain that regimen throughout the study
If patients are receiving non-pharmacological, behavioral and/or dietary interventions, they must be stable and have been doing so for three months prior to screening
Patients and parents/caregivers must be adequately informed of the nature and risks of the study and given written informed consent prior to Screening
In the Investigator's opinion, patients and parents/caregivers are reliable and willing and able to comply with all protocol requirements and procedures

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 AEDs: 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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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