NCT03162874已完成2 期
A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment With PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects With Parkinson's Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED)
Prexton Therapeutics45 个研究点 分布在 6 个国家目标入组 157 人开始时间: 2017年7月4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
- 已完成
- 发起方
- 入组人数
- 157
- 试验地点
- 45
- 主要终点
- Change from baseline to end of Treatment Period in the daily awake OFF time based on subject Hauser diary entries
研究概览
简要总结
This will be a double-blind, randomised, placebo-controlled parallel-arm phase II proof of concept in subjects with PD treated with a stable dose of levodopa who are experiencing both end-of-dose wearing off and Levodopa-Induced Dyskinesia (LID)
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
- •Males or females diagnosed after the age of 30 years with 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 who are on a long-acting formulation of levodopa-containing therapy, including Apodespan PR (or equivalent), must be on a stable dose for at least 6 weeks prior to the first screening visit
- •Experienced motor fluctuations with wearing off over a period of at least 3 months prior to randomisation
- •Experienced LID over a period of at least 3 months prior to randomisation
- •Female subjects will be women of non-childbearing potential
- •Subjects must pass a Hauser diary concordance test
- •Subjects are able, with or without the help of a caregiver, to understand the purpose and risks of the study and provide signed and dated informed consent and authorisation to use confidential health information in accordance with national and local subject privacy regulations
排除标准
- •Subjects with atypical, secondary or drug-induced Parkinsonism
- •Subjects with a Mini-Mental State Examination (MMSE) score <25
- •Any known contraindication to the use of levodopa, including a history of malignant melanoma or a history of narrow-angle glaucoma.
- •Subjects who have had a clinically significant illness within 4 weeks of first dose, as determined by the Investigator.
- •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 or transcranial magnetic stimulation.
- •Subjects who are participating in another clinical study (eg, attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months prior to the baseline visit.
- •Female subjects of childbearing potential
- •Subjects who are pregnant (as determined by positive serum pregnancy test at screening and/or baseline), breastfeeding or lactating.
- •Subjects who, in the opinion of the Investigator, should not participate in this study.
研究组 & 干预措施
PLACEBO
Placebo Comparator
干预措施: Placebo oral capsule (Drug)
PXT002331 - 10mg
Experimental
干预措施: PXT002331 - dose 1 (Drug)
PXT002331 - 30mg
Experimental
干预措施: PXT002331 - dose 2 (Drug)
结局指标
主要结局
Change from baseline to end of Treatment Period in the daily awake OFF time based on subject Hauser diary entries
时间窗: 28 days
次要结局
未报告次要终点
研究者
研究点 (45)
Loading locations...
相似试验
已完成
2 期
Trial of Topical Cidofovir for the Prevention of Hair GrowthPrevention of Hair GrowthNCT00948506University of Pennsylvania20
已完成
2 期
Efficacy, Safety and Pharmacokinetics of BI 655066/ABBV-066 (Risankizumab) in Patients With Active, Moderate-to-severe Crohn's Disease.Crohn DiseaseNCT02031276AbbVie121
已完成
2 期
Safety and Efficacy Study of TNX-201 Capsules for Treatment of Single Tension-Type HeadacheTension-Type HeadacheNCT02423408Tonix Pharmaceuticals, Inc.165
已完成
2 期
Trial of Centanafadine Efficacy and Safety as Monotherapy or as Adjunct to SSRI in Adults With Major Depressive DisorderMajor Depressive DisorderNCT05536414Otsuka Pharmaceutical Development & Commercialization, Inc.337
已完成
2 期
Study to Evaluate the Efficacy and Safety of KBP-042 in Patients With Type 2 DiabetesType 2 Diabetes MellitusNCT03230786KeyBioscience AG255