Fragile X Syndrome
Condition Description
A genetic condition causing intellectual disability.
Fragile X syndrome causes mild to severe intellectual disability. It affects both males and females, but females usually have milder symptoms.
Symptoms include delays in talking, anxiety, and hyperactive behavior. Some people have seizures. Physical features might include large ears, a long face, a prominent jaw and forehead, and flat feet.
Active Trials
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TRIAL TITLE: Clinical Study of Cannabidiol in Children and Adolescents With Fragile X Syndrome.
DESCRIPTION: This is a randomized, double-blind, placebo-controlled, multiple-center study, to assess the efficacy and safety of Cannabidiol administered as ZYN002 for the treatment of children and adolescent patients with Fragile X Syndrome (FXS). Eligible participants will participate in up to an 18 week treatment period, where all participants will receive placebo or active study drug. Patients ages 3 to < 18 years, will be eligible to participate.
SPONSOR: Zynerba Pharmaceuticals, Inc.
INDICATION: Fragile X Syndrome
STUDY PROTOCOL: ZYN2-CL-033
PHASE: 3
STATUS: Active
RECRUITING PATIENTS: Yes
Inquire About Trial →
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TRIAL TITLE: Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents With FXS
DESCRIPTION: ZYN002 is a pharmaceutically manufactured Cannabidiol that is developed as a clear gel that can be applied to the skin (called transdermal delivery). The gel will be applied to clean, dry, intact skin of the shoulders and/or upper arms. Participants from the ZYN2-CL-016 and ZYN2-CL-033 studies who meet the inclusion criteria and none of the exclusion criteria for study ZYN2-CL-017 are eligible. Parents/caregivers will apply the study gel twice daily for the 52-week treatment period.
SPONSOR: Zynerba Pharmaceuticals, Inc.
INDICATION: Fragile X Syndrome
STUDY PROTOCOL: ZYN2-CL-017
PHASE: 2 & 3
STATUS: Active
RECRUITING PATIENTS: Invitation Only