An Open-label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease Patients With Motor Fluctuations
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 419
- 试验地点
- 98
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and clinical utility of IPX203 in the treatment of participants with advanced Parkinson's disease (PD) who have motor fluctuations.
详细描述
This is a 9-month, multicenter open-label safety extension study. Participants who have successfully completed Study NCT03670953 [A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 with Immediate-Release (IR) Carbidopa-Levodopa (CD-LD) in Parkinson's Disease Patients with Motor Fluctuations] may have the opportunity to enroll in this open-label study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Successfully completed Study IPX203-B16-02
- •Able to provide written informed consent prior to the conduct of any study-specific procedures.
- •Female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit (Visit 1).
- •Agrees to use a medically acceptable method of contraception throughout the study and for 6 weeks after completing the study.
排除标准
- •Intends to use any doses of Rytary® or Duopa™ during this study.
- •Plans to use an investigational treatment other than IPX203 during the course of this study.
- •Neurosurgical ablation treatment for PD is planned or anticipated during the study period. Implantation of a deep brain stimulator (DBS) for the treatment of PD is permitted during this study.
- •Participants who, in the opinion of the clinical investigator, should not participate in the study.
研究组 & 干预措施
Open Label IPX203
All participants received oral administration of extended-release capsules IPX203 dosing regimen that was determined at the end of the IPX203 dose conversion period of Study IPX203-B16-02 (NCT03670953) for nine months of open-label therapy. The dose and dosing frequency was determined by the investigator to achieve the optimal balance of efficacy and safety.
干预措施: IPX203 (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events
时间窗: From first dose up to 1 day after last dose (Up to 9 months/Early Termination [ET])
An adverse event (AE) is any untoward medical occurrence in a participant or clinical trial participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE was considered as treatment-emergent if the date of onset was on or after the date of the first open-label study drug administration in this Study IPX203-B16-03 and no later than 1 day after the last study drug dose in the study.
次要结局
- Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Total(Baseline, Month 3, Month 6, and Month 9/ET)
- Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Total(Baseline, Month 9/ET)
- Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part I(Baseline, Month 3, Month 6, and Month 9/ET)
- Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part III(Baseline, Month 9/ET)
- Change From Baseline in Patient Global Impression of Severity (PGI-S)(Baseline, Month 9/ET)
- Clinical Global Impression of Severity (CGI-S)(Baseline, Month 3, Month 6, Month 9/ET)
- Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part II(Baseline, Month 3, Month 6, and Month 9/ET)
- Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Sums of Part II and Part III(Baseline, Month 9/ET)
- Change From Baseline in Clinical Global Impression of Severity (CGI-S)(Baseline, Month 9/ET)
- Treatment Satisfaction Assessment (TSA)(Month 3, Month 6 and Month 9/ET)
- Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part I(Baseline, Month 9/ET)
- Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part II(Baseline, Month 9/ET)
- Patient Global Impression of Severity (PGI-S)(Baseline, Month 3, Month 6, and Month 9/ET)
- Percentage of Participants With a PGI-S ≥ 4 and PGI-S ≥ 5(Baseline, Month 3, Month 6, and Month 9/ET)
- Parkinson Anxiety Scale (PAS): Total(Baseline, Month 3, Month 6, and Month 9/ET)
- Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part III(Baseline, Month 3, Month 6, and Month 9/ET)
- Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part IV(Baseline, Month 9/ET)
- Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Sums of Part II and Part III(Baseline, Month 3, Month 6, and Month 9/ET)
- Change From Baseline in PDQ-39: Total(Baseline, Month 9/ET)
- Change From Baseline in Parkinson Anxiety Scale (PAS): Total(Baseline, Month 9/ET)
- Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part IV(Baseline, Month 3, Month 6, and Month 9/ET)
- Percentage of Participants With a CGI-S ≥ 4 and CGI-S ≥ 5(Baseline, Month 3, Month 6, and Month 9/ET)
- 39-item Parkinson's Disease Questionnaire (PDQ-39): Total(Baseline, Month 3, Month 6, and Month 9/ET)
- Change From Baseline in Non-Motor Symptom Assessment Scale (NMSS) for Parkinson's Disease (PD): Total(Baseline, Month 9/ET)
- Parkinson's Disease Sleep Scale-2 (PDSS-2) Total(Baseline, Month 3, Month 6, and Month 9/ET)
- Change From Baseline in Parkinson's Disease Sleep Scale-2 (PDSS-2):Total(Baseline, Month 9/ET)
- Percentage of Participants With TSA Scores 5-7 (Satisfied) Versus Scores 1-4 (Dissatisfied or Neutral)(Month 3, Month 6, and Month 9/ET)
- Non-Motor Symptom Assessment Scale (NMSS) for Parkinson's Disease (PD): Total(Baseline, Month 3, Month 6, and Month 9/ET)