A Double-Blind, Randomized, Three-Arm, Parallel-Group Study to Assess the Efficacy and Safety of Two Doses of Pridopidine Versus Placebo for the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease (gLIDe)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 33
- 主要终点
- Change From Baseline in Levodopa-induced Dyskinesia as Measured by UDysRS Score
研究概览
简要总结
This is a multicenter, randomized, three-arm, parallel-group, double-blind, placebo-controlled, study to evaluate the efficacy, safety and pharmacokinetics (PK) of pridopidine vs. placebo for the treatment of Levodopa Induced Dyskinesia (LID) in patients with Parkinson Disease.
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
- •Provides signed informed consent form.
- •Has clinical diagnosis of Parkinson's Disease (PD).
- •Has Levodopa-induced dyskinesia (LID).
- •Patient and/or study partner must demonstrate ability to keep accurate home diary of PD symptoms.
- •Has stable anti-PD treatments for at least 28 days prior to start of study treatment and kept constant throughout study.
- •All routine and allowed prescription/non-prescription medications and/or nutritional supplements taken regularly must be at stable dosage for at least 28 days prior to start of study treatment and maintained throughout study.
排除标准
- •Diagnosis of atypical Parkinsonism.
- •Treatment with dopamine blocking drugs.
- •History of surgical intervention related to PD, such as deep brain stimulation.
- •History of severe depression, psychosis or hallucinations within 6 months prior to screening; active suicidal ideation; or suicidal attempt within 5 years prior to screening.
- •History of certain cancers within 5 years prior to screening.
- •Significant cardiac event within 12 weeks prior to Baseline or history of certain cardiac arrhythmias.
- •History of epilepsy or seizures within 5 years prior to screening.
- •Females who are pregnant or breastfeeding.
- •Sexually active female patients who are not surgically sterile or at least 2 years postmenopausal prior to screening, and who do not agree to utilize a highly effective hormonal method of contraception in combination with a barrier method, from screening until at least 4 weeks after completion of study treatment.
- •Male patients not using highly effective contraception or not agreeing to continue highly effective contraception until at least 90 days after the completion of study treatment.
- •Treatment with any investigational product within 30 days of screening or plans to participate in another clinical study assessing any investigational product during the study.
- •Other protocol-defined inclusion/exclusion criteria could apply.
研究组 & 干预措施
Pridopidine Dose 1
Dose 1 (oral capsule) for 12 weeks following 2 or 4 week dosage regimen titration period
干预措施: Pridopidine (Drug)
Pridopidine Dose 1
Dose 1 (oral capsule) for 12 weeks following 2 or 4 week dosage regimen titration period
干预措施: Placebo (Drug)
Pridopidine Dose 2
Dose 2 for (oral capsule) for 12 weeks following 2 or 4 week dosage regimen titration period
干预措施: Pridopidine (Drug)
Placebo
Matching placebo (oral capsule) for 16 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Levodopa-induced Dyskinesia as Measured by UDysRS Score
时间窗: Baseline; Visit 7 (at Week 16) planned. Since the study was terminated early due to the COVID-19 pandemic, analysis of the primary endpoint was done at Visit 5 (Week 8/10) in those patients who were on study drug at this visit.
Mean change from baseline (BL) in the sum of Parts 1, 3 and 4 of the Unified Dyskinesia Rating Scale (UdysRS), in the ON state. The UDysRS comprises 2 primary sections i.e. Historical \[Part 1 (ON-Dyskinesia) and Part 2 (OFF-Dystonia)\] and Objective \[Part 3 (Impairment) and Part 4 (Disability)\] assessment. ON-Dyskinesia are choreic and dystonic movements that occur when the Parkinson's disease (PD) medicine is working. Lower UDysRS values mean better patient outcome i.e. less dyskinesia. The UDysRS score for this study is calculated as sum of the parts, with scores of 0-44 for Part 1, 0-28 for Part 3 and 0-16 for Part 4.
次要结局
未报告次要终点