NCT03331848撤回2 期
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety, and Tolerability of 8-week Oral Treatment With PXT002331 (Foliglurax) in Reducing Levodopa-Induced Dyskinesia and Wearing OFF in Subjects With Parkinson's Disease Experiencing Motor Complications of Levodopa Therapy (ATTUNED)
Prexton Therapeutics0 个研究点开始时间: 2018年1月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Change from baseline in Unified Dyskinesia Rating Scale (UDysRS) total score in subjects with PD experiencing levodopa-induced dyskinesia.
研究概览
简要总结
This is a Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-arm Phase IIa proof of concept in subjects with PD treated with a stable dose of levodopa who are experiencing Motor Complications of Levodopa Therapy
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 35 and 85 years of age, inclusive, at the time of signing informed consent
- •Diagnosed after the age of 30 years with idiopathic PD
- •A documented medical history of idiopathic PD for at least 3 years
- •Disease severity of 2 to 4 on the modified Hoehn and Yahr scale when in the OFF state
- •Been treated with a stable regimen of levodopa-containing therapy
- •Subjects must be receiving at least 3 doses per day of levodopa-containing therapy, and must be on a stable dose for at least 2 weeks for immediate-release levodopa or at least 6 weeks for prolonged-release levodopa preparations prior to the first screening visit
- •Experienced LID over a period of at least 3 months prior to randomization
- •If needed, in the opinion of the investigator, subjects must have a caregiver
- •Female subjects will be women of non-childbearing potential
排除标准
- •Patient is currently participating in or has participated in another study in the last 3 months
- •Subjects with atypical, secondary, or drug-induced Parkinsonism
- •Subjects with a history of dyskinesia that was exclusively diphasic, OFF state, myoclonic, dystonic, or akathetic without peak-dose dyskinesia
- •Subjects with a MoCA score of <25
- •Subjects who have, or who had a history of, any clinically significant hepatic or gallbladder disorder, as determined by the investigator
- •Subjects who have dementia, currently active psychosis, or hallucinations.
- •Suicide attempt within 1 year prior to the first screening visit, or severe suicidal ideation within 6 months prior to the first screening visit
- •Subject has a current diagnosis of epilepsy,
- •Any known contraindication to the use of levodopa, including a history of malignant melanoma or a history of narrow-angle glaucoma
- •Carcinoma or successfully treated squamous cell carcinoma of the skin and no sing of disease recurrence for at least 5 years
- •Subjects who have had a clinically significant illness within 4 weeks before the first dose, as determined by the investigator
- •Subjects with scheduled surgeries/hospitalizations during the study period
- •Any advanced, severe, or unstable disease (other than PD) that may interfere with the primary and secondary study outcome evaluations
- •Subjects who have undergone prior neurosurgical operation for PD,
- •Subjects currently taking (or expected to be administered during the course of the study) any of the prohibited medications (amantadine, safinamide, dopamine-antagonists).
研究组 & 干预措施
PLACEBO
Placebo Comparator
干预措施: Placebo oral capsule (Drug)
PXT002331 - 20mg
Experimental
干预措施: PXT002331 - 20mg (Drug)
结局指标
主要结局
Change from baseline in Unified Dyskinesia Rating Scale (UDysRS) total score in subjects with PD experiencing levodopa-induced dyskinesia.
时间窗: 26 days
次要结局
未报告次要终点
研究者
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