NCT05766813已完成2 期
A Randomized, Double-blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 36
- 主要终点
- Hauser Diary
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in patients with a diagnosis of Parkinson's Disease consistent with the UK Parkinson's Disease Society (UKPDS) Brain Bank diagnostic criteria, who are experiencing wearing off symptoms and levodopa-induced dyskinesia.
详细描述
The study will be conducted in three periods:
- Screening Period (up to 4 weeks) during which patient eligibility will be assessed;
- Double-blind Treatment Period (4 weeks) in which all patients will be randomized to receive placebo or Lenrispodun 30 mg/day in 1:1 ratio.
- Safety Follow-up Period (1 week) in which all patients will return to the clinic for a safety follow-up visit approximately one week after the last dose of study treatment.
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)
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
- •Male or female between 40 years of age and older
- •Body mass index of 19.0-40.0 kg/m2;
- •Diagnosis of PD that is consistent with the UK Parkinson's Disease Society (UKPDS) Brain Bank diagnostic criteria;
- •Hoehn and Yahr Scale stage classification of 2 or 3 when in the ON state;
- •Have a clinically meaningful response to levodopa (levodopa + DDCI combination) based on Investigator assessment, and meet the following:
- •Have been on a stable and optimal dose of levodopa (levodopa + DDCI combination: minimum dose of levodopa equivalent to 100 mg three times daily) for at least 4 weeks prior to Screening, and are expected to continue the same dose regimen throughout the Double-blind Treatment Period;
- •If taking other anti-parkinsonian medications (MAO-B [monoamine oxidase B] inhibitor, COMT [catechol-O-methyltransferase] inhibitor, dopamine agonist) in addition to levodopa, have been on a stable dose for at least 4 weeks prior to Screening and are expected to continue the same dose regimen throughout the Double-blind Treatment Period;
- •7. Have wearing-off symptoms and levodopa-induced dyskinesia as per Investigator judgment;
- •Properly complete and return a self-reported home diary for motor function status (Hauser Diary) during the Screening Period, which confirms 3 days (ie, 3 consecutive, 24-hour periods) immediately prior to Baseline, each with at least 2½ hours of OFF time during waking hours.
- •9. Has a caregiver to assist with study participation, if determined by the Investigator to be necessary.
排除标准
- •Medical history indicating parkinsonism other than idiopathic PD, including but not limited to, progressive supranuclear gaze palsy, multiple system atrophy, drug-induced parkinsonism, essential tremor, primary dystonia;
- •Has late-stage PD, severe peak-dose dyskinesia, clinically significant end-dose or biphasic dyskinesia, and/or unpredictable or widely swinging fluctuations in their symptoms as assessed by the Investigator;
- •Exhibits clinical signs of dementia as indicated by the Mini-Mental State Examination, 2nd Edition: Standard Version (MMSE-2:SV) score of ≤ 24;
- •Use of moderate or strong CYP3A4 inhibitors within 5 half-lives of Baseline or CYP3A4 inducers within 2 weeks of Baseline;
- •Daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), with the exception of acetylsalicylic acid (ASA);
- •Use of MAO-A inhibitors, phosphodiesterase type 5 (PDE5) inhibitors, or alpha blockers including tamsulosin, within 5 half-lives of Baseline;
研究组 & 干预措施
Placebo
Placebo Comparator
Matching tablets administered orally, once daily.
干预措施: Placebo (Drug)
Lenrispodun 30 mg
Experimental
Lenrispodun 30 mg tablets administered orally, once-daily.
干预措施: Lenrispodun (Drug)
结局指标
主要结局
Hauser Diary
时间窗: Day 29
The Hauser Diary is a validated and commonly used patient-self-report home diary to assess motor symptoms in PD. It asks patients to characterize their predominant motor states in 30-minute intervals as Asleep, OFF, ON without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia.
次要结局
- Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(Day 29)
研究者
研究点 (36)
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