BENITIONSClinical Trial Intelligence

A Safety, Tolerability and Levodopa Pharmacokinetics Study of Repeated ND0612 in Parkinson's Disease Patients

2期 已完成 NCT01883505

适应症Parkinson's Disease
分期2期
申办方NeuroDerm Ltd.
状态已完成
受试者人数30 人
干预(药物)ND0612, Entacapone
开始日期2014年1月6日
完成日期2015年4月26日
结果公布日2026年7月9日

摘要

This is a randomized, placebo-controlled, double-blind, 2-period study evaluating the safety and pharmacokinetics (PK) of ND0612 in Parkinson's disease (PD) patients on an optimized oral levodopa (LD) regimen and experiencing ≥2 h/day of OFF time. Safety and tolerability, PK profile, pump usability, and the potential clinical effect of ND0612 will be explored in subjects with PD and motor fluctuations.

Maximum Dermal Rating Score: Draize Score

14 days (Period 1) · score

Period 1. ND06121.6 ± 1.38 score
Period 1. Placebo1.0 ± 1.41 score

Maximum Dermal Rating Score: Erythema and Eschar Formation

14 days (Period 1) · score

Period 1. ND06121.0 ± 0.88 score
Period 1. Placebo0.36 ± 0.81 score

Maximum Dermal Rating Score: Edema

14 days (Period 1) · score

Period 1. ND06120.82 ± 1.08 score
Period 1. Placebo1.2 ± 1.79 score

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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。