A Randomized, Double-Blind, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects With Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- "ON" time without disabling dyskinesias
研究概览
简要总结
The purpose of this study is to compare the clinical efficacy of IPX054 to immediate-release carbidopa-levodopa in subjects with Parkinson's disease.
详细描述
IPX054 contains two different drugs called levodopa and carbidopa in one tablet.
- levodopa turns into a material called 'dopamine' in your brain. The dopamine helps to improve the symptoms of your Parkinson's disease.
- carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase inhibitors'. It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with idiopathic Parkinson's disease based on CAPIT (Core Assessment Program for Intracerebral Transplantations) criteria.
- •Currently being treated with immediate-release carbidopa-levodopa with a stable dosing regimen over the past 4 weeks.
排除标准
- •Diagnosed with atypical parkinsonism.
- •Allergic or non-responsive to previous carbidopa-levodopa therapy.
- •Active or history of narrow-angle or wide-angle glaucoma.
- •History of seizure or epilepsy, or is currently taking an anti-convulsant for treatment of seizure.
- •Requires concomitant therapy with tricyclic antidepressants, MAO-B inhibitors, COMT inhibitors or anticholinergics.
- •Treatment with any neuroleptic agent, including atypical neuroleptics, within the previous 6 months.
- •Treatment with any dopaminergic blocking agent within the previous 6 months.
研究组 & 干预措施
IPX054 - CD-LD IR
Subjects received IPX054 200 mg b.i.d and CD-LD IR Placebo q.i.d for 2 weeks and then received IPX054 Placebo b.i.d and CD-LD IR q.i.d for 2 weeks.
干预措施: IPX054 Placebo (Drug)
IPX054 - CD-LD IR
Subjects received IPX054 200 mg b.i.d and CD-LD IR Placebo q.i.d for 2 weeks and then received IPX054 Placebo b.i.d and CD-LD IR q.i.d for 2 weeks.
干预措施: IPX054 200 mg (Drug)
IPX054 - CD-LD IR
Subjects received IPX054 200 mg b.i.d and CD-LD IR Placebo q.i.d for 2 weeks and then received IPX054 Placebo b.i.d and CD-LD IR q.i.d for 2 weeks.
干预措施: CD-LD IR (Drug)
IPX054 - CD-LD IR
Subjects received IPX054 200 mg b.i.d and CD-LD IR Placebo q.i.d for 2 weeks and then received IPX054 Placebo b.i.d and CD-LD IR q.i.d for 2 weeks.
干预措施: CD-LD IR Placebo (Drug)
CD-LD IR - IPX054
Subjects received IPX054 Placebo b.i.d and CD-LD IR q.i.d for 2 weeks and then IPX054 200 mg b.i.d and CD-LD IR Placebo q.i.d for 2 weeks.
干预措施: IPX054 200 mg (Drug)
CD-LD IR - IPX054
Subjects received IPX054 Placebo b.i.d and CD-LD IR q.i.d for 2 weeks and then IPX054 200 mg b.i.d and CD-LD IR Placebo q.i.d for 2 weeks.
干预措施: CD-LD IR (Drug)
CD-LD IR - IPX054
Subjects received IPX054 Placebo b.i.d and CD-LD IR q.i.d for 2 weeks and then IPX054 200 mg b.i.d and CD-LD IR Placebo q.i.d for 2 weeks.
干预措施: IPX054 Placebo (Drug)
CD-LD IR - IPX054
Subjects received IPX054 Placebo b.i.d and CD-LD IR q.i.d for 2 weeks and then IPX054 200 mg b.i.d and CD-LD IR Placebo q.i.d for 2 weeks.
干预措施: CD-LD IR Placebo (Drug)
结局指标
主要结局
"ON" time without disabling dyskinesias
时间窗: 2 weeks
次要结局
- UPDRS analysis(2 weeks)
- Mean time to "ON"(2 weeks)
- Mean time to "wearing OFF"(2 weeks)