Therapeutic Efficacy of DA-9701 on Gastric Motility in Patients With Parkinson's Disease Evaluated by Magnetic Resonance Imaging: A Randomized Controlled, Double-Blind, Non-Inferiority Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change of gastric motility evaluated using MRI from baseline at 4 weeks after the treatment
研究概览
简要总结
This study will evaluate the therapeutic efficacy and safety of DA-9701 with domperidone in patients with Parkinson's disease
详细描述
To prevent nausea and vomiting induced by anti-parkinsonian drugs, prokinetic drugs are frequently prescribed in patients with Parkinson's disease (PD). Additionally, there has been some evidence that prokinetics might improve PD symptom fluctuations. From this background, the investigators will evaluate the therapeutic efficacy and safety of DA-9701 in PD patients.
In this study, 40 patients will be enrolled and randomly allocated 1:1 to receive either domperidone or DA-9701. The gastric function of each study participant will be evaluated using the MRI technique before and after 4 weeks of the treatment. The study participants will also be subjected to complete the gastrointestinal symptom diary before and during the treatment period. In addition, plasma levodopa concentrations will be determined 30 minutes after dose administration before and after treatment.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects diagnosed with spontaneous parkinsonism by the United Kingdom(UK) Parkinson's Disease Society Brain Bank criteria
- •subjects who are able to explain symptoms they experience and to complete relevant assessment and exams including questionaires
- •subjects who understand the purpose and protocols of the study and agree to participate on the study
排除标准
- •subjects who experience psychiatrical disorders such as cognitive or behavioral disorders
- •subjects who are on prokinetics or who are unable to cease such medication
- •subjects who present neurological disorders which influence gastrointestinal mobility
- •subjects who present gastrointestinal conditions which influence gastrointestinal mobility
- •subjects with a history of gastrectomy or colectomy
- •subjects who are unable to receive and complete the course of medication due to other metabolic disorders
- •subjects diagnosed with parkinson plus syndrome
- •subjects who are unable to undergo MRI scan for safety reasons due to claustrophobia or certain devices such as cardiac pacemakers or aneurysm clips
研究组 & 干预措施
DA-9701
In this arm, the study participants will receive DA-9701 30mg + placebo domperidone tablet tid ac for 4 weeks.
干预措施: DA-9701 (Drug)
DA-9701
In this arm, the study participants will receive DA-9701 30mg + placebo domperidone tablet tid ac for 4 weeks.
干预措施: Placebo domperidone (Drug)
Domperidone
(This study is a randomized, double-blinded, non-inferiority trial. Thus it is designed to have no placebo arm.) In this arm, the study participants will receive domperidone 10mg + placebo DA-9701 tablet tid ac +for 4 weeks.
干预措施: Domperidone (Drug)
Domperidone
(This study is a randomized, double-blinded, non-inferiority trial. Thus it is designed to have no placebo arm.) In this arm, the study participants will receive domperidone 10mg + placebo DA-9701 tablet tid ac +for 4 weeks.
干预措施: Placebo DA-9701 (Drug)
结局指标
主要结局
Change of gastric motility evaluated using MRI from baseline at 4 weeks after the treatment
时间窗: 0, 4 weeks
MRI is known to be accurate and useful in evaluating gastric motility. Gastric emptying rate (GER) evaluated using MRI will be compared before and after the treatment, and between the groups.
次要结局
- Levodopa plasma concentration 30 minutes after the L-dopa administration(0, 4 weeks)
- UPDRS Part III score(0, 4 weeks)
- Patient's symptoms of dyspepsia and constipation assessed patient diary(-1 to 4 weeks)