NCT00489255已完成4 期
A Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Trimethobenzamide (Tigan®) in the Control of Nausea and Vomiting During Initiation and Continued Treatment With Subcutaneous Apomorphine (Apokyn®) in Apomorphine-naïve Subjects With Parkinson's Disease Suffering From Acute Intermittent "Off" Episodes, With Phased Withdrawal of Subjects From Tigan® to Placebo
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 117
- 试验地点
- 27
- 主要终点
- Incidence of Nausea and/or Vomiting During the Initial Titration of Apokyn® at the Visit on Day 1
研究概览
简要总结
The purposes of the study are to determine:
i. To assess the efficacy of Tigan® (trimethobenzamide) in preventing nausea and vomiting when initiating therapy with Apokyn® (apomorphine)
ii. To determine the optimal duration for continuation of Tigan® following initiation of Apokyn® therapy
iii. To assess the safety of Tigan® in combination with Apokyn®
iv. To characterize the pharmacokinetic (PK) profile of apomorphine in subjects treated concomitantly with and without Tigan®
详细描述
Initial randomization is Tigan or Placebo (3:1) with phased withdrawal of Tigan to Placebo after 4 and 8 weeks. Subjects completing 4 weeks Tigan re-randomized to Tigan or Placebo (2:1) with patients completing 8 weeks Tigan re-randomized to receive Tigan or Placebo (1:1). Subjects randomized to Placebo over the previous 4 weeks assigned to continue on Placebo for the remainder of the study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18 years or over
- •Subjects with advanced Parkinson's disease with disabling hypomobility ("off" episodes) who are to be initiated with Apokyn® by intermittent subcutaneous injection
- •Able to swallow Tigan®/placebo capsules
- •Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
- •Women of child bearing potential must have a negative serum pregnancy test (beta hCG) prior to receiving study drug and must be using an appropriate form of contraception
- •Willing and able to provide informed consent
排除标准
- •Hypersensitive to apomorphine hydrochloride or any of the ingredients of Apokyn® (notably sodium metabisulfite)
- •Hypersensitive to trimethobenzamide or any of the ingredients of Tigan®
- •Previous treatment with Apokyn®
- •Participation in any other clinical trial within 14 days of the present trial
- •Contraindications to Apokyn® or Tigan®
- •Currently taking, or likely to need to take at any time during the course of the study, any 5HT3 antagonist (ondansetron, alosetron, granisetron, palonosetron or dolasetron)
- •Malignant melanoma or a history of previously treated malignant melanoma
- •Pregnancy or breast feeding
- •Receipt of any investigational (i.e. unapproved) medication within 30 days of starting the present trial
- •Any significant medical disorder, condition, concomitant medication or psychiatric disorder according to DSM-IV criteria which would, in the opinion of the investigator, represent a hazard to the subject or prevent the subject from completing the trial
研究组 & 干预措施
Trimethobenzamide (Tigan®)
Experimental
干预措施: Tigan® (Drug)
Inactive substance
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Nausea and/or Vomiting During the Initial Titration of Apokyn® at the Visit on Day 1
时间窗: Day 1 (Period 1, Visit 2)
次要结局
- Incidence of Nausea and/or Vomiting for Period 2(Days 29-56)
- Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 3(Days 57-84)
- Median Time to 'on' for Visit 2/Period 1 Injection 1(Day 1 (Visit 2))
- Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 2, Pre Apokyn Dose, Period 1(Day 1 (Visit 2))
- Incidence of Nausea and/or Vomiting for Period 1(Days 1-28)
- Incidence of Nausea and/or Vomiting for Period 3(Days 57-84)
- Median Time to 'on' for Visit 2/Period 1 Injection 2(Day 1 (Visit 2))
- Median Time to 'on' for Visit 4/End of Period 2 Injection(Day 56 (Visit 4))
- Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Post Apokyn Dose, Period 2(Day 56 (Visit 4))
- Subject Global Evaluation of Randomized Study Medication for Period 1(Day 28 (Visit 3))
- Median Time to 'on' for Visit 5/End of Period 3 Injection(Day 84 (Visit 5))
- Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Pre Apokyn Dose, Period 2(Day 56 (Visit 4))
- Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Post Apokyn Dose, Period 3(Day 56 (Visit 4))
- Subject Global Evaluation of Randomized Study Medication for Period 3(Day 84 (Visit 5))
- Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Pre Apokyn Dose, Period 1(Day 28)
- Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 1(Days 1-28)
- Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 2(Days 29-56)
- Subject Global Evaluation of Randomized Study Medication for Period 2(Day 56 (Visit 4))
- Median Time to 'on' for Visit 3/End of Period 1 Injection(Day 28)
- Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Post Apokyn Dose, Period 1(Day 28)
- Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Pre Apokyn Dose, Period 3(Day 84 (Visit 5))
研究者
研究点 (27)
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