An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004

Intec Pharma, Ltd.0 个研究点目标入组 460 人开始时间: 2016年3月18日最近更新: 2019年12月10日

研究概览

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•1. Men or women with PD and who successfully completed the core study IN 11 004
•2. Subjects for whom, in the opinion of the Investigator, the PD diagnosis is still valid and subjects remain eligible for LD therapy
•3. Subjects able to understand and sign written informed consent to participate in the study
•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 140
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 320

•1. Participation in another clinical trial and receipt of an investigational medication within 28 days prior to the planned start of treatment (prior participation in IN 11 004 clinical trial is required)
•2. Previous or planned functional neurosurgical treatment for PD (e.g., procedures including ablation or deep brain stimulation) during study participation
•3. Concomitant non-steroidal anti-inflammatory drugs (NSAID?s) and oral steroids within 90 days prior to Baseline Visit or planned concomitant administration during study participation
•4. Non-selective monoamine oxidase (MAO) inhibitors within 28 days prior to Baseline Visit or planned administration during study participation.
•5. Catechol-O-methyltransferase (COMT) inhibitors within 14 days prior to Baseline Visit or planned administration during study participation
•6. Opioids within 7 days prior to Baseline Visit or planned administration during study participation
•7. In the opinion of the Investigator, subject should not participate in the study

发起方