2025-524655-30-00招募中2 期
Interventional, randomized, double-blind, parallel-group, placebo-controlled, flexible-dose trial of Lu AF28996 in adults with Parkinson’s disease experiencing motor fluctuations.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 6
- 主要终点
- Change From Baseline to Week 19 in Daily Good ON Time Based on the Participant’s Hauser Diary Entries
研究概览
简要总结
To assess the efficacy of Lu AF28996 in improving motor complications in PD.
研究设计
- 分配方式
- Randomized
- 主要目的
- Part B
- 盲法
- Double (Monitor, Investigator, Analyst, Subject, Carer)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •The participant was diagnosed with PD ≥3 years ago, with the diagnosis being established after the age of 30 years and consistent with the Movement Disorders Society (MDS) Clinical Diagnostic Criteria for “clinically established” or “clinically probable” PD.
- •The participant has a modified Hoehn and Yahr scale (mH&Y) stage ≤3 in the ON state and ≥2 and ≤4 in the OFF state.
- •The participant reports well recognizable, consistent motor fluctuations causing significant disability per investigator’s judgement over a period of ≥3 months prior to screening.
- •The participants report motor fluctuations each day as measured by OFF-time during awake hours.
排除标准
- •The participant has previously been dosed with Lu AF
- •The participant has participated in a clinical trial <30 days prior to screening.
- •The participant is pregnant, breastfeeding, intends to become pregnant, or is of child-bearing potential and not willing to use adequate contraceptive methods.
- •The participant has taken any investigational medicinal product (IMP) <3 months or <5 half-lives, whichever is longer, prior to screening.
- •The participant has a Montréal Cognitive Assessment (MoCA) score ≤24 (adjusted for education).
- •The participant has an atypical, secondary, or drug-induced Parkinsonism (for example, metoclopramide, flunarizine), metabolic identified neurogenetic disorders (for example, Wilson’s disease), encephalitis, or Parkinson Plus syndromes or other forms of atypical Parkinsonian syndromes (for example, progressive supranuclear palsy and multiple system atrophy).
- •The participant has severe, pervasive, disabling dyskinesia which, in the setting of the present trial, may interfere with his/her safe participation in the trial (for example, threat to falling, aspiration, etc.) as judged by the investigator.
- •The participant has unpredictable motor fluctuations as evidenced by an MDS-UPDRS Part IV Item 4.5 score ≥3 at screening and/or experiences wide, unpredictable fluctuations of PD symptoms per investigator’s clinical judgement.
结局指标
主要结局
Change From Baseline to Week 19 in Daily Good ON Time Based on the Participant’s Hauser Diary Entries
Change From Baseline to Week 19 in Daily Good ON Time Based on the Participant’s Hauser Diary Entries
次要结局
- Change From Baseline to Week 19 in Participant's MDS-UPDRS Total Score
- Change From Baseline to Week 19 in Participant's MDS-UPDRS Part I Score
- Change From Baseline to Week 19 in Participant's MDS-UPDRS Part II Score
- Plasma Concentrations of Lu AF28996 and Metabolites
- Change From Baseline to Week 19 in Daily OFF Time Based on Participant’s Hauser Diary Entries
- Change From Baseline to Week 19 in Daily ON Time With Troublesome Dyskinesia Based on Participant’s Hauser Diary Entries in Participants Reporting ≥1 Hour of Daily ON Time With Troublesome Dyskinesia at Baseline
- Change From Baseline to Week 19 in Participant’s Unified Dyskinesia Rating Scale (UDysRS) Total Score in Participants Reporting ≥1 Hour of Daily ON Time With Troublesome Dyskinesia at Baseline
- Participant’s Achievement at Week 19 of a Reduction in Daily OFF Time, Defined as >1.5 Hour/Day Reduction
- Participant’s Achievement at Week 19 of an Increase in Daily Good ON Time >1.5 Hour/Day
- Participant’s Achievement at Week 19 of a Reduction in Both Daily ON Time With Troublesome Dyskinesia AND in OFF time in Participants Reporting ≥1 Hour of Daily ON Time With Troublesome Dyskinesia at Baseline
- Change From Baseline to Week 19 in Clinical Global Impression – Severity of Illness (CGI-S) Score
- Change From Baseline to Week 19 in Participant's Movement Disorder Society-Unified Parkinson’s Disease-Rating Scale (MDS-UPDRS) Part III Score
- Change From Baseline to Week 19 in Participant's Movement Disorders Society Non-Motor Rating Scale (MDS-NMS) Domain Scores and Total Score
- Change From Baseline to Week 19 in Participant's Parkinson’s Disease Sleep Scale Version 2 (PDSS-2) Total Score
- Change From Baseline to Week 19 in Participant’s MDS-UPDRS Part IV (B) (Questions 4.1, 4.2, 4.3, 4.4 Item Scores), and Part IV Score
- Change From Baseline to Week 19 in Participant's Parkinson’s Disease Questionnaire-39 (PDQ-39) Score
- Change From Baseline to Week 19 in Participant's EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L) Visual Analogue Scale Score
- Change From Baseline to Week 19 in Daily Oral Levodopa (mg)
- Change From Baseline to Week 19 in Levodopa-equivalent Dose (LED)
- Change From Baseline to Week 19 in Total Levodopa-equivalent Daily Dose (LED)
- Patient Global Impression of Change (PGI-C) Score at Week 19
- Change From Baseline to Week 19 in Daily ON Time With Troublesome Dyskinesia Based on Participant's Hauser Daily Entries
- Change From Baseline to Week 19 in Daily ON Time Without Troublesome Dyskinesia Based on Participant's Hauser Daily Entries
- Change From Baseline to Week 19 in Daily ON Time With Non-troublesome Dyskinesia Based on Participant's Hauser Daily Entries
- Change From Baseline to Week 19 in Participant's UDysRS Total Score and Combined Partial Scores of Part 1 + Part 2, Part 3 + Part 4, and Part 1 + Part 3 + Part 4, in Participants With UDysRS Total Score ≥20 at Baseline
- Number of Participants With Achievement of a Reduction in Daily ON Time With Troublesome Dyskinesia at Week 19
- Number of Participants With Achievement of No Worsening in Daily ON Time With Troublesome Dyskinesia at Week 19
研究者
Lundbeck Clinical Trials
Scientific
H. Lundbeck A/S
研究点 (6)
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