An Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of ZYN002 Administered as a Transdermal Gel to Children and Adolescents with Fragile X Syndrome – CONNECT-FX Open Label Extension (OLE)

Zynerba Pharmaceuticals Pty. Ltd0 个研究点目标入组 300 人开始时间: 2018年11月16日最近更新: 2018年11月26日

适应症

试验速览

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•1.Participated in a certain number of visits in the ZYN2-CL-016 study
•2.Patients and parents/caregivers agree to abide by all study restrictions and comply with all study procedures.
•3.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.
•4.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.
•5.Females of childbearing potential must have a negative pregnancy test at all designated visits

•1.Patient is receiving any investigational drugs (not ZYN002) or using any experimental devices.
•2.Patient has an ongoing serious adverse event (SAE) or has experienced a SAE in ZYN2-CL-016, which in the opinion of the Investigator, should exclude them from participation.
•3.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 as outlined below for the duration of therapy and for three months after the last dose of trial drug.
•4.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.

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