NCT02469090已完成3 期
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy, Safety and Tolerability of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 33
- 主要终点
- Mean Change From Pre-Dose to 30 Minutes Post-Dose in The Movement Disorders Society Unified Parkinson's Disease Rating Scale Part III Motor Examination (MDS-UPDRS Part III) Score at Maintenance Visit 4 (MV4) - Week 12
研究概览
简要总结
A 12-week, prospective, multi-center, randomized, double-blind, placebo controlled, Phase 3 study in L-Dopa responsive PD patients with motor fluctuations ("OFF" episodes), designed to determine the efficacy, safety and tolerability of APL-130277.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 years of age.
- •Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria.
- •Clinically meaningful response to L-Dopa with well-defined early morning "OFF" episodes, as determined by the Investigator.
- •Receiving stable doses of L-Dopa/carbidopa (immediate or CR) administered at least 4 times per day OR Rytary™ administered 3 times per day, for at least 4 weeks before the initial Screening Visit
- •No planned medication change(s) or surgical intervention anticipated during the course of study.
- •Patients must experience at least one well defined "OFF" episode per day with a total daily "OFF" time duration of ≥ 2 hours during the waking day, based on patient self-assessment.
- •Stage III or less on the modified Hoehn and Yahr scale in the "ON" state.
- •MMSE score > 25.
排除标准
- •A patient will not be eligible for study entry if any of the following exclusion criteria are met:
- •Atypical or secondary parkinsonism.
- •Previous treatment with any of the following: a neurosurgical procedure for PD; continuous s.c. apomorphine infusion; or Duodopa/Duopa.
- •Treatment with any form of s.c. apomorphine within 7 days prior to the initial Screening Visit (SV1). Patients that stopped s.c. apomorphine for any reason other than systemic safety concerns or lack of efficacy may be considered.
- •Contraindications to APOKYN®, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of APOKYN® (notably sodium metabisulfite); Tigan® (trimethobenzamide hydrochloride; patients from US sites only); or domperidone (patients from non-US sites only).
- •Participation in a clinical trial within 30 days prior to the initial Screening Visit (SV1).
- •Currently taking selective 5HT3 antagonists (i.e., ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents.
- •Drug or alcohol dependency in the past 12 months.
- •History of malignant melanoma.
- •Clinically significant medical, surgical, or laboratory abnormality in the opinion of the Investigator.
- •Major psychiatric disorder including, but not limited to, dementia, bipolar disorder, psychosis, or any disorder that, in the opinion of the Investigator, requires ongoing treatment that would make study participation unsafe or make treatment compliance difficult.
- •History of clinically significant hallucinations during the past 6 months.
- •History of clinically significant impulse control disorder(s).
- •Dementia that precludes providing informed consent or would interfere with participation in the study.
研究组 & 干预措施
APL-130277
Experimental
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
干预措施: APL-130277 (Drug)
Placebo
Placebo Comparator
Matching placebo for APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Pre-Dose to 30 Minutes Post-Dose in The Movement Disorders Society Unified Parkinson's Disease Rating Scale Part III Motor Examination (MDS-UPDRS Part III) Score at Maintenance Visit 4 (MV4) - Week 12
时间窗: At t=0 (just prior to dosing) and t=30 minutes at MV4 (Week 12 of the Maintenance Treatment Phase).
The Motor Function section (Part III) of the MDS-UPDRS was administered by the Investigator, and included 33 scores based on 18-items, each anchored with 5 responses: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range was from 0 to 132, with a lower score indicating better motor function and a higher score indicating more severe motor symptoms. The least square mean change in the MDS-UPDRS Part III score from pre-dose to 30 minutes post-dose at MV4 is presented. A negative change from pre-dose indicates an improvement.
次要结局
- Percentage of Patients With a Patient-related Full 'ON' Response Within 30 Minutes at MV4 - Week 12: Predicted Response Rate(At t=30 minutes at MV4 (Week 12 of the Maintenance Treatment Phase).)
- Percentage of Patients With a Patient-related Full 'ON' Response Within 30 Minutes That Had a Duration of Effect of at Least 30 Minutes at MV4 - Week 12: Predicted Response Rate(At MV4 (Week 12 of the Maintenance Treatment Phase).)
- Patient Global Impression of Improvement (PGI-I): Percentage of Patients Who Improved at MV4 - Week 12(At MV4 (Week 12 of the Maintenance Treatment Phase).)
- Clinician Global Impression of Improvement (CGI-I): Percentage of Patients Who Improved at MV4 - Week 12(At MV4 (Week 12 of the Maintenance Treatment Phase).)
- Mean Change From Screening Visit to MV4 (Week 12) in MDS-UPDRS Part II: Motor Aspects of Experience of Daily Living(At Screening Visit and at MV4 (Week 12 of the Maintenance Treatment Phase).)
- Mean Percentage of Instances Where a Full 'ON' Response Was Achieved at 30 Minutes Post-dose on the Home Dosing Diary Entries During the 2 Days Prior to MV4 - Week 12(2 days prior to MV4 (Week 12 of the Maintenance Treatment Phase).)
- Mean Change From Screening Visit to MV4 in the Parkinson's Disease Quality of Life Questionnaire (PDQ-39) Summary Index Score(At Screening Visit and at MV4 (Week 12 of the Maintenance Treatment Phase).)
- Mean Change From Pre-Dose to 15 Minutes Post-Dose in the MDS-UPDRS Part III Score at MV4 - Week 12(At t=0 (just prior to dosing) and t=15 minutes at MV4 (Week 12 of the Maintenance Treatment Phase).)
- Time From Dosing to When Study Medication Provided an Effect at MV4 - Week 12(At MV4 (Week 12 of the Maintenance Treatment Phase).)
研究者
研究点 (33)
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