Open-Label Continuation Treatment Study With Levodopa - Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 262
- 试验地点
- 61
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events
研究概览
简要总结
The primary objective of this study is to provide continued access to levodopa-carbidopa intestinal gel (LCIG), to participants who have already participated in an open-label efficacy and safety study with the same treatment (Study S187.3.003 [NCT00360568] or Study S187.3.004 [NCT00335153]).
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
- 30 Years 至 99 Years（Adult, Older Adult）
- 接受健康志愿者
- 否
入选标准
- •The participant should have completed participation in Study S187.3.003 or S187.3.004; and, in the opinion of the Principal Investigator, would benefit from long-term treatment with LCIG.
- •For Canada, participants will be allowed to participate in the S187.3.005 study with a minimum of 6 months of exposure to LCIG in the S187.3.004 study.
- •The participant must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study related procedures. If the participant does not have the capacity to provide informed consent, full informed consent must be obtained from the participant's legally authorized representative. Consenting will be performed according to local regulations.
排除标准
- •Medical, laboratory, psychiatric, or surgical issues deemed by the investigator to be clinically significant and which could interfere with the participant's participation in the study.
研究组 & 干预措施
Levodopa-Carbidopa Intestinal Gel
Initial dosing is based on the dosing regimen that the participant received during the previous LCIG study. Dosing is individually optimized and can be adjusted at any time during the study as clinically indicated. The total dose/day of LCIG is composed of 3 individually adjusted doses. The morning dose is administered as a bolus infusion, usually 5 to 10 mL (100 to 200 mg levodopa). The maintenance dose is adjustable in steps of 2 mg/hour (0.1 mL/hour), within a range of 1 to 10 mL/hour (20 to 200 mg levodopa/hour) and is usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour). Participants will be allowed to self-administer extra doses of LCIG to address immediate medical needs, normally 0.5 to 2.0 mL.
Participants will receive LCIG until it is commercially available.
干预措施: Levodopa-Carbidopa Intestinal Gel (LCIG) (Drug)
Levodopa-Carbidopa Intestinal Gel
Initial dosing is based on the dosing regimen that the participant received during the previous LCIG study. Dosing is individually optimized and can be adjusted at any time during the study as clinically indicated. The total dose/day of LCIG is composed of 3 individually adjusted doses. The morning dose is administered as a bolus infusion, usually 5 to 10 mL (100 to 200 mg levodopa). The maintenance dose is adjustable in steps of 2 mg/hour (0.1 mL/hour), within a range of 1 to 10 mL/hour (20 to 200 mg levodopa/hour) and is usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour). Participants will be allowed to self-administer extra doses of LCIG to address immediate medical needs, normally 0.5 to 2.0 mL.
Participants will receive LCIG until it is commercially available.
干预措施: CADD-Legacy® 1400 ambulatory infusion pump (Device)
Levodopa-Carbidopa Intestinal Gel
Initial dosing is based on the dosing regimen that the participant received during the previous LCIG study. Dosing is individually optimized and can be adjusted at any time during the study as clinically indicated. The total dose/day of LCIG is composed of 3 individually adjusted doses. The morning dose is administered as a bolus infusion, usually 5 to 10 mL (100 to 200 mg levodopa). The maintenance dose is adjustable in steps of 2 mg/hour (0.1 mL/hour), within a range of 1 to 10 mL/hour (20 to 200 mg levodopa/hour) and is usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour). Participants will be allowed to self-administer extra doses of LCIG to address immediate medical needs, normally 0.5 to 2.0 mL.
Participants will receive LCIG until it is commercially available.
干预措施: Percutaneous Endoscopic Gastrostomy with jejunal extension tube (PEG-J) (Device)
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events
时间窗: From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, with a maximum of 4217 days (11.5 years).
Treatment-emergent adverse events (TEAEs) are defined as adverse events (AEs) which started on or after the date of the first LCIG Infusion in this study and within 30 days of the date of the last PEG-J exposure. At least possibly drug-related is defined as TEAEs assessed as having a "Possible" or "Probable" or missing relationship to study drug. Serious AEs included any untoward medical occurrence that: * Resulted in death * Was life-threatening * Required inpatient hospitalization or prolongation of an existing hospitalization * Resulted in persistent or significant disability/incapacity * was a congenital anomaly/birth defect The severity of all AEs was characterized as mild, moderate or severe according to the following definitions: * Mild: usually transient and do not interfere with daily activities. * Moderate: low level of inconvenience or concern to the subject, may interfere with daily activities. * Severe: events interrupt the subject's usual daily activity.
次要结局
- Number of Participants With Device Complications(From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days.)
- Number of Participants Who Developed Melanoma(Once per year during the study; median duration of treatment was 1178 days.)
- Number of Participants With Treatment-emergent Adverse Events of Special Interest (TE AESI)(From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, with a maximum of 4217 days (11.5 years).)
- Number of Participants With Potentially Clinically Significant Hematology Laboratory Values(Baseline and every 6 months until final visit; median duration of treatment was 1178 days.)
- Number of Participants With Intense Impulsive Behavior(Baseline (final assessment of the previous open-label LCIG study) and every 6 months until final visit; median duration of treatment was 1178 days.)
- Number of Participants With Potentially Clinically Significant Chemistry Laboratory Values(Baseline and every 6 months until final visit; median duration of treatment was 1178 days.)
- Number of Participants With Sleep Attacks(Baseline (final assessment period of the previous open-label LCIG study) and every 6 months until final visit; median duration of treatment was 1178 days.)
- Number of Participants With Any Suicidal Ideation or Behavior(Every 6 months (beginning with implementation of Protocol Amendment 3) until final visit; median duration of treatment was 1178 days.)
- Number of Participants With Potentially Clinically Significant Vital Sign Values(Baseline and every 6 months until final visit; median duration of treatment was 1178 days.)
- Number of Participants With Vitamin Levels Outside of the Normal Range(Every 6 months (beginning with implementation of Protocol Amendment 2) until final visit; median duration of treatment was 1178 days.)
- Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at End of Treatment(Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.)
- Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Dyskinesia Score at End of Treatment(Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.)
- Number of Participants Receiving Concomitant Anti-Parkinson's Disease Medications by Treatment Year(Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, Year 10, > Year 10 (maximum time on treatment was approximately 11.5 years).)
- Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at End of Treatment(Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.)
- Change in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at End of Treatment(Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.)
- Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at End of Treatment(Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.)
- Change in Parkinson's Disease Questionnaire (PDQ-39) Scores at End of Treatment(Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.)
- Change in Average Daily "Off" Time Based on the Parkinson's Disease Symptom Diary at End of Treatment(Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.)
- Change in Average Daily "On" Time With Troublesome Dyskinesia Based on the Parkinson's Disease Symptom Diary at End of Treatment(Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.)
- Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at End of Treatment(Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.)
- Change in Average Daily "On" Time Without Troublesome Dyskinesia Based on the Parkinson's Disease Symptom Diary at End of Treatment(Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.)