A Multicenter, Randomized, Active-controlled, Double-blind, Double-dummy, Parallel-group Clinical Trial, Investigating the Efficacy, Safety, and Tolerability of Continuous Subcutaneous ND0612 Infusion in Comparison to Oral IR-LD/CD in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (BouNDless)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 381
- 试验地点
- 103
- 主要终点
- The change in daily ON time without troublesome dyskinesia
研究概览
简要总结
This is a multi-center, randomized, double-blind, double-dummy, active controlled clinical Study. Following a screening period, eligible subjects will be enrolled to an open-label oral IR-LD/CD adjustment period; then an open-label ND0612 conversion period; then after optimization periods subjects will be randomized to receive either ND0612 or its matching Placebo with IR-LD/CD.
Subjects can continue to an optional open-label extension period.
详细描述
This is a phase III multi-center, randomized, active-controlled, double-blind, double-dummy (DBDD), parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous (SC) ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson's disease (PD) experiencing motor fluctuations.
This study is comprised of 6 periods:
- a Screening Period;
- an open-label oral IR-LD/CD Adjustment Period;
- an open-label ND0612 Conversion Period;
- a randomized DBDD active-controlled Maintenance Period;
- an optional open-label Treatment Extension; and
- a Safety Follow-up Period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Blinded Site Rater, Blinded Clinical Research Associates (CRAs), active drugs and matching placebos are identical in their appearances.
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
- •Male and female patients, aged ≥30 years.
- •PD diagnosis consistent with the United Kingdom Brain Bank Criteria.
- •Modified Hoehn & Yahr score ≤3 during "ON" state.
- •Average of ≥2.5 hours of OFF time (≥2 hours "OFF" time every day) during waking hours as confirmed by patient diary over 3 days.
- •Taking ≥4 levodopa doses/day (≥3 doses/day of extended release LD/dopa-decarboxylase inhibitor, e.g., Rytary®) at a total daily dose of ≥400mg.
排除标准
- •Atypical or secondary parkinsonism.
- •Severe disabling dyskinesias, based on Investigator's discretion.
- •Previous neurosurgery for PD.
- •Use of duodenal levodopa infusion (LCIG) or apomorphine infusion.
- •Use of the following medications: subcutaneous apomorphine injections, sublingual apomorphine, or inhaled levodopa within 4 weeks.
- •Previous participation in ND0612 studies.
- •History of significant skin conditions or disorders.
研究组 & 干预措施
ND0612 Group
ND0612 continuous SC infusion + Active IR-LD/CD (grey capsules) + Placebo IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks.
干预措施: ND0612 Solution for SC infusion (Combination Product)
ND0612 Group
ND0612 continuous SC infusion + Active IR-LD/CD (grey capsules) + Placebo IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks.
干预措施: Oral IR-LD/CD (Drug)
ND0612 Group
ND0612 continuous SC infusion + Active IR-LD/CD (grey capsules) + Placebo IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks.
干预措施: Placebo for Oral IR-LD/CD (Drug)
IR-LD/CD Group
Placebo for ND0612 continuous SC infusion + Placebo IR-LD/CD (grey capsules) + Active IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks.
干预措施: Placebo for SC infusion (Combination Product)
IR-LD/CD Group
Placebo for ND0612 continuous SC infusion + Placebo IR-LD/CD (grey capsules) + Active IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks.
干预措施: Oral IR-LD/CD (Drug)
IR-LD/CD Group
Placebo for ND0612 continuous SC infusion + Placebo IR-LD/CD (grey capsules) + Active IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks.
干预措施: Placebo for Oral IR-LD/CD (Drug)
Oral IR-LD/CD Adjustment
Active IR-LD/CD (white capsules). Open-label Treatment in Run-in 1 for 4-6 weeks.
干预措施: Oral IR-LD/CD (Drug)
ND0612 Conversion
ND0612 continuous SC infusion + Active IR-LD/CD (grey capsules). Open-label Treatment in Run-in 2 for 4-6 weeks.
干预措施: ND0612 Solution for SC infusion (Combination Product)
ND0612 Conversion
ND0612 continuous SC infusion + Active IR-LD/CD (grey capsules). Open-label Treatment in Run-in 2 for 4-6 weeks.
干预措施: Oral IR-LD/CD (Drug)
Open-Label Extension
ND0612 continuous SC infusion + Standard of care LD/dopa-decarboxylase inhibitor. Open-label Treatment in Extension for up to 54 months.
干预措施: ND0612 Solution for SC infusion (Combination Product)
结局指标
主要结局
The change in daily ON time without troublesome dyskinesia
时间窗: Baseline to the end of DBDD Maintenance Period (12 weeks)
ON time without troublesome dyskinesia is the sum of ON time without dyskinesia and ON time with non-troublesome dyskinesia per patient diary
次要结局
- The change in daily OFF time(Baseline to the end of DBDD Maintenance Period (12 weeks))