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A Randomized, Double-Blind, Placebo-Controlled Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children, Adolescents, and Young Adults with Fragile X Syndrome - RECONNECT

The purpose of this study is to investigate how effective and safe ZYN002, a transdermal gel, is in patients with FXS in managing behavioral symptoms.

If you qualify for this study, you will be assigned by chance to get one of the following treatments: • Active Study Drug – ZYN002 • Placebo If you decide to participate in this voluntary research study: • A review of your medical history, demographics, and medications • A complete physical and neurological exam • Tanner stage assessments (checking body for physical signs of puberty) • 12 lead electrocardiogram • Vital signs ( blood pressure, heart rate, respiratory rate, and body temperature) • Collection of blood samples (blood draw) • Urine test • Questionnaires/scales to test behavior • IQ test

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Patricia Gordon
Patricia Gordon - at pgordon@pennstatehealth.psu.edu
Pediatrics: Hematology/Oncology (HERSHEY)
 
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This study is NOT accepting healthy volunteers
NCT04977986
STUDY00018453
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Inclusion Criteria:
Diagnosis of Fragile X Syndrome
Ages 3-22
Exclusion Criteria:
Use of THC or CBD containing products within 3 months of screening
Females who are pregnant, nursing, or planning a pregnancy
Children's Health, Mental & Behavioral Health
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See this study on ClinicalTrials.gov
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Hershey, PA ,