NCT00036205终止3 期
Open-Label, Long Term, Flexible Dose Study Of Safety, Tolerability, And Therapeutic Response In Patients With Parkinson's Disease.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 984
- 试验地点
- 108
- 主要终点
- The primary objective is to assess the long term safety and tolerability of sumanirole by measuring Safety labs, ECG monitoring, vital signs and adverse events, over a period of up to 4 years.
研究概览
简要总结
The primary objective is to assess the long term safety and tolerability of sumanirole as measured by safety labs, ECG monitoring, vital signs, and adverse event reports in subjects with Parkinson's Disease who participated in previous sumanirole studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's disease
- •Modified Hoehn and Yahr Scale Stages 1-4
- •Age over 30 years
- •Previous participation in prior sumanirole studies
排除标准
- •Use of dopamine agonist medications and other medications in defined timeframe
- •Unstable dose of CNS active therapies (eg, hypnotics, antidepressants, anxiolytics) within the last 30 days
- •Atypical Parkinson's syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases
- •History of active epilepsy within the past year
- •Significant liver disease with defined laboratory criteria
- •Significant renal disease with defined laboratory criteria
- •Certain cardiac conditions
- •Electroconvulsive therapy in the previous 90 days
- •Subjects participating in other drug studies or receiving other investigational drugs within previous 30 days
- •Positive pregnancy test at Screen
- •Unwillingness to use adequate contraceptive methods
- •Lactating women
- •History of stereotaxic brain surgery
- •Malignant melanoma or history of treated melanoma
结局指标
主要结局
The primary objective is to assess the long term safety and tolerability of sumanirole by measuring Safety labs, ECG monitoring, vital signs and adverse events, over a period of up to 4 years.
次要结局
- Pharmacoeconomics, quality of life, and the long term therapeutic response associated with sumanirole by using Parts II and III of the UPDRS (Unified Parkinson's Disease Rating Scale).
- Part II -- Activities of Daily Living, will be collected in order to record the patient's level of function between visits.
- Part III will be used to evaluate motor function.
- Three quality of life instruments will be employed: a general scale--the Functional Status Questionnaire, a disease specific scale--the Parkinson's Disease Questionnaire, and a utility scale--the EuroQol.
研究者
研究点 (108)
Loading locations...
相似试验
终止
3 期
Open-label Extension for Phase 3 Clinical Trials of SimufilamAlzheimer DiseaseNCT05575076Cassava Sciences, Inc.1,081
终止
3 期
Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I DisorderDepressionNCT01121536Cephalon867
已完成
3 期
Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset SeizuresPartial-onset SeizuresEpilepsyNCT01832038UCB Pharma SA473
已完成
3 期
Long-term Safety and Tolerability of Cariprazine for Bipolar I DisorderBipolar I DisorderNCT01059539Forest Laboratories403
已完成
1 期
A Safety and Pharmacokinetic Study of Paliperidone Palmitate in Patients With SchizophreniaSchizophreniaNCT01150448Johnson & Johnson Pharmaceutical Research & Development, L.L.C.212