Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 83
- 主要终点
- Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8
研究概览
简要总结
This is a multi-center, randomized, double-blind, placebo-controlled, 4-arm parallel group study to evaluate the tolerability and efficacy of each of three dose levels of ADS-5102 oral capsules, an extended release formulation of amantadine, dosed once daily for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) higher amantadine plasma concentrations during daytime hours when dyskinesia as well as motor and non-motor symptoms of PD are most problematic, ii) low amantadine plasma concentrations overnight, which may reduce the sleep disturbances and vivid dreams occasionally associated with amantadine, and iii) a reduced initial rate of rise in plasma concentration, which is expected to improve overall tolerability of amantadine.
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
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed a current IRB/IEC-approved informed consent form
- •Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria
- •On a stable regimen of antiparkinson's medications , including any levodopa preparation administered not less than three times daily, and willing to continue the same doses and regimens during study participation
- •Experiencing troublesome dyskinesia following levodopa dosing (peak dose dyskinesia)
- •Able to understand and complete a standardized PD home diary, following training
排除标准
- •History of neurosurgical intervention related to Parkinson's disease (e.g. deep brain stimulation)
- •History of seizures or stroke/TIA within 2 years of screening
- •History of cancer within 5 years of screening, except adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer or in situ cervical cancer
- •Estimated GFR < 50 mL/min/1.73m2
- •Presence of cognitive impairment, as evidenced by a Mini-Mental Status Examination (MMSE) score of less than 24 during screening
- •If female, is pregnant or lactating, or has a positive pregnancy test result pre-dose
- •If a sexually active female, is not surgically sterile or at least 2 years post-menopausal, or does not agree to utilize an effective method of contraception from screening through at least 4 weeks after the completion of study treatment
- •Treatment with an investigational drug or device within 30 days prior to screening
- •Treatment with an investigational biologic within 6 months prior to screening
研究组 & 干预措施
Treatment A
干预措施: ADS-5102 (extended release amantadine HCl) (Drug)
Treatment B
Low dose ADS-5102 (amantadine extended release)
干预措施: ADS-5102 (extended release amantadine HCl) (Drug)
Treatment C
A mid-dose ADS-5102 (amantadine extended release)
干预措施: ADS-5102 (extended release amantadine HCl) (Drug)
Treatment D
High dose ADS-5102 (amantadine extended release)
干预措施: ADS-5102 (extended release amantadine HCl) (Drug)
结局指标
主要结局
Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8
时间窗: Baseline (Day 1) and Week 8
The UDysRS is a dyskinesia rating scale from 0-104, and it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The last observation carried forward (LOCF) method was used for analysis. Participants were summarized according to the actual treatment received.
次要结局
- Change in Total Objective Score (III, IV) of the UDysRS From Baseline to Week 8(Baseline (Day 1) and Week 8)
- Change in ON Time Without Troublesome Dyskinesia (ON Without Dyskinesia Plus ON With Non-troublesome Dyskinesia) From Baseline to Week 8; Based on a Standardized PD Home Diary(Baseline (Day 1) and Week 8)
- Change in the Fatigue Severity Score (FSS) From Baseline to Week 8(Baseline (Day 1) and Week 8)
- Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Scores (Parts I, II, III) From Baseline to Week 8(Baseline (Day 1) and Week 8)
- Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8(Baseline (Day 1) and Week 8)