An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects Who Participated in the ADAGIO Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 684
- 试验地点
- 102
- 主要终点
- Hoehn and Yahr scale
研究概览
简要总结
Eligible participants, who participated in the ADAGIO trial and who sign an approved informed consent form, will be enrolled into the study at their original study locations. participants who have stopped rasagiline therapy and in the opinion of the investigator will gain clinical benefit from restarting treatment can also be considered for enrollment in the Core follow-up study period. Use of any other anti-PD treatment is permitted as deemed necessary by the treating physician (according to the participants clinical status).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who participated in the ADAGIO study, and who entered the active phase of the study and
- •Subjects who are currently on rasagiline treatment (or subjects who have stopped rasagiline treatment, are willing to restart treatment, and in the opinion of the investigator will gain clinical benefit from restarting treatment) and
- •Subjects with a diagnosis of Parkinson's disease and
- •Subjects willing and able to give written informed consent
排除标准
- •Subjects who have discontinued rasagiline treatment due to an adverse event and have not restarted rasagiline treatment subsequently.
- •Subjects who cannot be given rasagiline due to any exclusion based on the local label (including pregnancy or nursing women) or due to the use of medications contraindicated for concomitant use with rasagiline according to local label
- •Subjects with a medical condition that is considered by the investigator as significant enough to prevent participation
研究组 & 干预措施
Rasagiline mesylate
Enrollment by invitation to participates from the ADAGIO trial
干预措施: rasagiline mesylate (Drug)
结局指标
主要结局
Hoehn and Yahr scale
时间窗: 36 months
0 indicates asymptomatic to 5 which indicates wheelchair bound
Parkinson's Fatigue Scale
时间窗: 36 months
1 indicates strongly disagree to 5 which indicates strongly agree
PD Functional Status Questionnaire
时间窗: 36 months
Assess Benefits of rasagiline treatment using yes/no questions; Milestones of time to treatment-Dopaminergic treatment, levodopa, surgery for PD, time to -dyskinesia, hallucinations, functional decline using an aggregate of the responses to PD Functional Status Questionnaire
UPDRS scores
时间窗: 36 months
Part I is designed to rate mentation, behavior and mood (questions 1-4). Part II (questions 5-17) is designed to rate activities of daily life. Both parts I and II are to be collected as historical information. Part III (questions 18-31) is done as a motor examination at the time of a visit as defined in this protocol. The various items to be rated are scored using a 5-point system (i.e., 0 is normal and 4 indicates a severe abnormality, half point scores are allowed for Part III questions).
EDL scale
时间窗: 36 months
Montreal Cognitive Assessment (MoCA) Scale
时间窗: 36 months
assessment of mild cognitive deficits
Non-motor symptom questionnaire of the PD Society
时间窗: 36 months
Yes/No questions
Quality of Life Questionnaire
时间窗: 36 months
Qualitative questions using Never to Always answers
次要结局
未报告次要终点