An Extension Study to Assess the Safety and Efficacy of Intermittent Bilateral Intraputamenal Glial Cell Line-Derived Neurotrophic Factor (GDNF) Infusions Administered via onvection Enhanced Delivery (CED) in Subjects with Parkinson’s Disease - Intermittent Bilateral GDNF for Parkinson’s Disease

orth Bristol NHS Trust (NBT)0 个研究点目标入组 42 人开始时间: 2013年8月5日最近更新: 2019年4月30日

适应症

试验速览

暂无简介。

•In order to qualify for entry into the study, subjects MUST meet all of the following criteria:
•1. Enrolled and completed treatment in the Pilot or Primary Study Stages of Study 2553.
•2. Females of childbearing potential must have a negative pregnancy test at study entry and be willing to use an approved (by the PI or designee) form of contraception until the end of the study.
•3. Males with female partners of childbearing potential must be willing to use condoms for contraception until the end of the study.
•4. Provision of informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 12

•Subjects who meet any of the following criteria will NOT be eligible for inclusion in the study:
•1. Discontinued treatment early in Study 2553.
•2. Had any significant (in the opinion of the PI or designee) protocol deviation in Study 2553; this includes receipt of any disallowed anti-parkinsonian treatment or any investigational treatment.
•3. Presence of clinically significant (in the opinion of the PI) depression.
•4. MoCA score < 24 at the final assessment in Study 2553.
•5. Any new medical condition which might impair outcome measure assessments or safety measures including ability to undergo MRI scanning.

发起方

orth Bristol NHS Trust (NBT)