WHAT ARE THE RECONNECT STUDY QUALIFICATIONS?
3 - 29
YEARS OLD
Between the ages of 3 and 29
Diagnosed with FXS via genetic testing
Experiencing behavioral symptoms of FXS
About this Study
DO YOU CARE FOR A CHILD, ADOLESCENT OR YOUNG ADULT WITH FRAGILE X?
People with Fragile X syndrome (FXS) often experience behavioral symptoms such as:
Anxiety — particularly social anxiety / avoidance
Irritability
Tantrums
Social unresponsiveness
The behavioral symptoms associated with a Fragile X diagnosis can create daily challenges for your child, your family and you. A clinical trial known as RECONNECT is currently enrolling participants to evaluate an investigational, topical treatment that may help improve Fragile X-related behavioral symptoms.
WHAT IS THE STUDY MEDICATION?
The study medication is pharmaceutically produced cannabidiol (not extracted from the cannabis plant). It comes as a clear topical gel that is applied directly to the skin by rubbing into the upper arm and shoulder (like you would rub in sunscreen).
WILL A CANNABIDIOL TREATMENT CAUSE MY CHILD TO GET “HIGH”?
The study medication is pharmaceutically produced cannabidiol that contains no THC, which is the element of cannabis that causes a euphoric or “high” effect. Thus, there is no “high” experienced by children participating in the study.
HOW IS THE MEDICATION ADMINISTERED?
The dose of study medication depends on the weight of the participant:
≤ 66 lbs (30 kg)
2 PACKETS OF GEL/DAY
- 1 packet approximately every 12 hours
- Total daily dose of 250 mg
> 66 lbs (30 kg) to ≤ 110 lbs (50 kg)
4 PACKETS OF GEL/DAY
- 2 packets approximately every 12 hours
- Total daily dose of 500 mg
> 110 lbs (50 kg)
6 PACKETS OF GEL/DAY
- 3 packets approximately every 12 hours
- Total daily dose of 750 mg
Parents or caregivers will be instructed on proper application of the gel to clean, dry, intact skin of the upper arms/shoulders.
RECONNECT IS BEING CONDUCTED AT CENTERS ACROSS THE U.S. OR AT PARTICIPANTS’ HOMES.
OPTION 1: MIX OF IN-CLINIC AND AT-HOME VISITS
OPTION 2: COMPLETELY AT-HOME
