Status:
ENROLLING_BY_INVITATION
Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents With FXS
Lead Sponsor:
Zynerba Pharmaceuticals, Inc.
Conditions:
Fragile X Syndrome
Eligibility:
All Genders
3-29 years
Phase:
PHASE2
PHASE3
Brief Summary
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 ski...
Detailed Description
This is an open-label extension, multiple-center study, to assess the long-term safety and tolerability of cannabidiol administered as ZYN002, a transdermal gel, for the treatment of child and adolesc...
Eligibility Criteria
Inclusion
- Participated in study ZYN2-CL-016 or Study ZYN2-CL-033.
- Patients and parents/caregivers agree to abide by all study restrictions and comply with all study procedures.
- Patients and parents/caregivers must be adequately informed of the nature, risks of the study, and give written informed consent prior to enrollment in ZYN2-CL-017.
- In the Investigator's opinion, the patients and parents/caregivers are reliable and are willing and able to comply with all protocol requirements and procedures.
- Females of childbearing potential must have a negative pregnancy test at all designated visits
Exclusion
- Patient is receiving any investigational drugs (not ZYN002) or using any experimental devices.
- Patient has an ongoing serious adverse event (SAE) or has experienced a SAE in ZYN2-CL-016 or ZYN2-CL-033, which in the opinion of the Investigator, should exclude them from participation.
- Females who are pregnant, nursing, or planning a pregnancy; females of childbearing potential and male patients with a partner of childbearing potential who are unwilling or unable to use an acceptable method of contraception for the duration of therapy and for three months after the last dose of trial drug.
- Patients who have alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels ≥ 2 times the upper limit of normal (ULN) or has alkaline phosphatase levels ≥ 3 times the ULN as determined from patient safety laboratories.
Key Trial Info
Start Date :
November 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT03802799
Start Date
November 9 2018
End Date
August 31 2027
Last Update
November 5 2025
Active Locations (26)
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1
Southwest Autism Research and Resource Center
Phoenix, Arizona, United States, 85006
2
Science 37
Culver City, California, United States, 90230
3
Amnova Clinical Research, LLC
Irvine, California, United States, 92604
4
UC Davis Health System, MIND Institute
Sacramento, California, United States, 95817