A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Multiple Center, Multiple-Dose Study to Assess the Safety and Efficacy of ZYN002 Administered as a Transdermal Gel to Patients with Partial Onset Seizures (STAR 1)

Zynerba Pharmaceuticals Pty Ltd0 个研究点目标入组 210 人开始时间: 2016年4月20日最近更新: 2020年1月13日

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•Eligible participants include males and non-pregnant, non-lactating females, with confirmed epilepsy, with Partial Onset Seizures (POS) for at least 5 years; who have on average at least three observable POS per month; who are being treated and maintained on a stable regimen of AED(s); who are able and willing to maintain a daily diary; and have an acceptable (protocol defined) body mass index (18-35 kg/m2).
•Females of childbearing potential and males with a partner of childbearing potential must use an acceptable method of contraception, from at least 21 days prior to the first dose of study drug and for 28 days after the last dose of study drug. Participants must agree to comply with all study restrictions and procedures, provide written informed consent and, in the investigator’s opinion, be reliable.

•Excluded are patients with a history of relevant allergic reactions; who have been exposed to any investigational drug or device in the last 30 days; who have used any marijuana-containing product within the last four weeks; who have changed tobacco product(s) use within the last 30 days; who have certain types of epilepsy or non-epileptic seizures within the last 5 years; who are using certain (protocol defined) AEDs or have changed AED regimen in the last 4 weeks; who have had epilepsy dietary therapy started within the last 3 months; who have any diseases or conditions that are likely to require changes in drug therapy during the study or interfere with the objectives of the study; who are at risk of suicide; who have Hepatitis or HIV; who have a positive drug screen for (protocol defined) drugs, including alcohol, or who have a history of alcohol or drug abuse.

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