Efficacy and Safety of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia in Parkinson's Disease Patients (EASE LID Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 126
- 主要终点
- Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 12
研究概览
简要总结
This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once nightly at bedtime 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) maximal concentrations in the early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in the evening, potentially reducing the negative impact of amantadine on sleep. This pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER formulation than can be tolerated with an immediate-release formulation. The once-nightly dosing regimen may also provide enhanced convenience and compliance.
In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.
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/REB/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 for at least 30 days prior to screening, including a levodopa preparation administered not less than three times daily, and willing to continue the same doses and regimens during study participation
- •Following diary training, the subject is willing and able to understand and complete the 24-hour PD home diary (caregiver/study partner assistance allowed)
- •Any other current and allowed prescription/non-prescription medications and/or nutritional supplements taken regularly must have been at a stable dose and regimen for at least 30 days prior to screening, and subject must be willing to continue the same doses and regimens during study participation (this criterion does not apply to medications that are being taken pre-study only on an as-needed basis)
排除标准
- •History of neurosurgical intervention related to Parkinson's disease (e.g. deep brain stimulation)
- •History of seizures within 2 years prior to screening
- •History of stroke or transient ischemic attack (TIA) within 2 years prior to screening
- •History of cancer within 5 years prior to screening, with the following exceptions: adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer or in situ cervical cancer
- •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
- •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
- •Current participation in another clinical trial
研究组 & 干预措施
ADS-5102
ADS-5102 (amantadine HCl extended release)
干预措施: ADS-5102 (Drug)
Placebo
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 12
时间窗: Baseline to Week 12
The UDysRS is a dyskinesia rating scale from 0-104; it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The UDysRS was measured at Baseline and Weeks 2, 8, 12, 18, and 24.
次要结局
- Change in the Standardized PD Home Diary (ON Time Without Troublesome Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time)(Baseline (BL) to Week 12 (W12) and Week 24 (W24))
- Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms(Baseline to Week 12 and Week 24)
- Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 24(Baseline to Week 24)
- Change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Score (Parts I, II, and III)(Baseline (BL) to Week 12 (W12) and Week 24 (W24))