EUCTR2009-017182-38-PL进行中（未招募）不适用
An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson’s Disease.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Successful completion of studies IPX066 B08-05, IPX066 B08 11, or IPX066 B09 02.
- •2.In the opinion of the Investigator, the Parkinson’s disease diagnosis is still valid and the subject remains eligible for LD therapy.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Received an investigational medication other than those from an IPX066 trial within 4 weeks prior to the planned start of treatment.
- •2.Anticipates functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) during study participation.
- •3.Received within 4 weeks prior to Baseline Visit or planning to take during study participation: nonselective monoamine oxidase (MAO) inhibitors (with the exception of rasagiline).
- •4.In the opinion of the Investigator, should not participate in the study.
研究者
相似试验
进行中（未招募）
不适用
An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson’s Disease.Idiopathic Parkinson’s disease (paralysis agitans).MedDRA version: 12.1Level: LLTClassification code 10061536Term: Parkinson's diseaseEUCTR2009-017182-38-DEImpax Laboratories, Inc. acting through its Impax Pharmaceuticals Division500
进行中（未招募）
不适用
An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s DiseaseEUCTR2009-017182-38-LTImpax Laboratories, Inc. acting through its Impax Pharmaceutical Division (Impax)500
进行中（未招募）
不适用
An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s DiseaseIdiopathic Parkinson´s disease (paralysis agitans)MedDRA version: 12.1Level: LLTClassification code 10061536Term: Parkinson's diseaseEUCTR2009-017182-38-EEImpax Laboratories, Inc. acting through its Impax Pharmaceutical Division (Impax)500
进行中（未招募）
不适用
An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s DiseaseIdiopathic Parkinson´s disease (paralysis agitans)MedDRA version: 12.1Level: LLTClassification code 10061536Term: Parkinson's diseaseEUCTR2009-017182-38-LVImpax Laboratories, Inc. acting through its Impax Pharmaceutical Division (Impax)500
进行中（未招募）
1 期
An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease patients with motor fluctuationsParkinson's diseaseMedDRA version: 20.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: PTClassification code 10028035Term: Movement disorderSystem Organ Class: 10029205 - Nervous system disordersEUCTR2018-002234-21-DEImpax Laboratories, LLC300