Global REsponsE During iNFusIon of a gEl With LevoDopa/Carbidopa (GREENFIELD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 主要终点
- Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 39 (Proportion of Waking Day Spent in "Off") Score: Mean Change From Baseline to the Last Available Follow up
研究概览
简要总结
This multicenter, post marketing observational study (PMOS) was designed to evaluate the long-term effectiveness of levodopa/carbidopa intestinal gel (DUODOPA) on motor fluctuations (duration of OFF periods) in participants with advanced levodopa-responsive Parkinson's disease (PD) and severe motor fluctuations and hyper-/dyskinesia (involuntary movements). Secondary objectives of this study were to assess the participants' quality of life; to assess the long-term safety of DUODOPA; to assess disability, cognitive function, and non-professional caregiver burden; and to assess the economic and social impact of family caregiver assistance.
详细描述
Male or female participants ages 18 years of age who were already on DUODOPA treatment and had concluded the naso-intestinal phase were included in this study. DUODOPA was administered via a portable pump directly into the proximal small intestine via a percutaneous endoscopic transgastric jejunostomy (PEG-J) tube. There were 3 planned visits during the study: enrollment (Visit 1), 1 year (Visit 2), and 2 years (Visit 3).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants already on treatment with DUODOPA (having already concluded the naso-intestinal treatment phase) according to the local DUODOPA product label and to routine clinical care for advanced PD patients
- •Participants with available data on DUODOPA treatment, on previous PD conventional treatments and with at least one of the scales/questionnaires under study already collected on the participant's clinical chart
- •Participant or legal representative has given written informed consent
- •Non-professional caregiver (relative or familiar who give daily assistance to the patient) has given his/her written consent
排除标准
- •History or presence of any condition that might interfere with the long-term continuation of the duodenal infusion of DUODOPA
结局指标
主要结局
Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 39 (Proportion of Waking Day Spent in "Off") Score: Mean Change From Baseline to the Last Available Follow up
时间窗: Baseline/Visit 1 and Visit 2 (Year 1) or Visit 3 (Year 2)
Section B of the UPDRS IV questionnaire consists of 4 individual items that assess the degree of clinical fluctuations. Item 39 is the percentage of "off" times (when PD symptoms are not adequately controlled by the drug) during the waking day. The Item 39 score ranges from 0 (None), 1 (1- 25% of the waking day), 2 (26 - 50% of the waking day), 3 (51 - 75% of the waking day), and 4 (76 - 100% of the waking day). The mean change from baseline was calculated as the score at the last available follow up visit minus the score at baseline/Visit 1. Negative change from baseline for "off" time indicates improvement.
次要结局
- Change in Parkinson's Disease Quality of Life Questionnaire (PDQ-39) Scores(Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2))
- Change in Gait and Falls Questionnaire (GFQ) Scores(Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2))
- Change in Relative Stress Scale (RSS) Scores(Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2))
- Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Part A+B Score: Mean Change From Baseline to Visits 2 and 3(Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2))
- Change in Parkinson's Disease Sleep Scale Version 2 (PDSS-2) Scores(Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2))
- Change in Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) Scores(Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2))
- Economic and Social Impact of Family-provided Healthcare(Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2))
- Change in Unified Parkinson's Disease Rating Scale on Mentation, Behavior and Mood (UPDRS I) and Activities of Daily Living (UPDRS II) During On and Off Phases(Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2))
- Concomitant Diseases and Medications(Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2))
- Change in Global Effectiveness on Motor Symptoms as Compared to Baseline(Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2))
- Participant Self-assessment Scale of DUODOPA Therapy(Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2))
- DUODOPA Total Daily Infusion Dosage(Baseline, Visit 1, Visit 2, (Year 1) and Visit 3 (Year 2))