Clinical Trial RECONNECT: ZYN002 Gel

RECONNECT clinical trial is now enrolling males and females from the age of 3 years up to 29 years old!

RECONNECT offers 2 options for participation:

     Option 1: Mix of In-Clinic and At-Home Visits

     Option 2: Completely At-Home Visits

The RECONNECT clinical trial will evaluate the effectiveness and safety of ZYN002, a clear cannabidiol gel applied twice a day to the skin (called transdermal application) for the treatment of behavioral symptoms of Fragile X syndrome (FXS).  Eligible participants will participate in up to an 18-week study treatment period, where all participants will receive placebo or active study drug.  Participants ages 3 to 29 years will be eligible to participate if they meet all entry criteria.

ZYN002, is the first and only investigational pharmaceutically produced cannabidiol, a non-psychoactive cannabinoid, formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system.  ZYN002 is an investigational treatment.  This means that it is not approved by government regulatory bodies, including the United States Food and Drug Administration (FDA) and must be tested to see if it is an effective and safe study treatment.

Who can participate?

Males and females, age 3 to 29 years of age with full mutation FXS may be eligible to participate.

What will happen in the study?

• Initial Assessments to determine eligibility may be done remotely.
• If eligibility is met on these initial assessments, a visit (in-clinic or at-home) will be scheduled to complete the remaining screening assessments.

The following is a list of some of the study procedures that will happen during the study:

• Blood samples for genetic testing to confirm diagnosis of full mutation FXS and methylation status
• Blood samples and electrocardiogram (ECG) for safety monitoring
• Parent/caregiver questionnaires to assess the severity of symptoms of FXS

What are the potential beneficial outcomes that can happen from my son/daughter participating in this research?

Caregivers and their son/daughter will receive medical care associated with the conduct of the study at no charge.

Their participation will provide important information to help determine whether the study medication is safe and effective in FXS.  This information will be reviewed by the FDA.  If the study medication is deemed safe and effective, the medication may become available for use by other individuals with FXS.

What are the potential negative outcomes that can happen from my son/daughter participating in this research?

Overall, the active study medication has been well tolerated in previous studies in individuals with FXS.  The most common adverse events are application site reactions such as pain or redness.  Individuals may also experience discomfort related to the procedure to take blood samples.

There may be other risks that we do not know about yet.

Will I/my son/daughter be paid to be in this research study?

Participants will not receive payment for participation in the study.  Participants may receive reimbursement for reasonable study-related costs such as travel and incidental expenses (parking, meals) and for their time in completion of some assessments.  A stipend may be provided to the caregiver for completing study assessments.

Contact

To find out more, call (833) 680-1155 or visit FRAGILEXHELP.com