NCT02209155终止2 期
A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 2 Study to Evaluate the Safety and Efficacy of R-Verapamil in the Prophylaxis of Episodic Cluster Headache
Center Laboratories, Inc.1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Change in the average daily frequency of attacks
研究概览
简要总结
This is a double-blinded, randomized, parallel, placebo-controlled phase 2 study to evaluate the safety and efficacy of R-verapamil in the prophylaxis of episodic cluster headache.
详细描述
Approximately 30 subjects (about 15 per treatment group),will be enrolled and randomized to receive either R-verapamil or placebo for 2 weeks. The study will consist of a 1-week run-in period and a 2-week treatment period (R-verapamil or placebo). The total duration of the study for each treatment group is 3 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy man or woman between the ages of 18 and 65
- •In good health as determined by medical history and medical examination
- •Has a diagnosis of episodic cluster headache as defined by the International Classification of Headache Disorders (2nd edition)
- •Has a lifetime prevalence of at least 2 prior cluster bouts - Subjects must experience at least 7 attacks/week during the run-in baseline period
- •Subjects must have a typical cluster period lasting at least 1 month. Subjects must be present in active cluster period and the expected remaining duration of the cluster cycle must be at least 3 weeks from Baseline Day 1 visit
- •Able to differentiate other headache types from cluster headaches
- •Is using or agrees to use a medically acceptable form of contraception(female of child-bearing potential)
- •Negative urine pregnancy test prior to study entry(female of child-bearing potential)
- •Concomitant medication that, in the opinion of the investigator and the patient's general practitioner(GP), do not pose an unacceptable risk based upon the prescribing information for verapamil
- •Able to understand and comply with all study requirements
- •Written informed consent
排除标准
- •Women who are pregnant or lactating
- •Subjects who, in the investigators opinion, have a history or have evidence of a medical or psychiatric condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability
- •Use of any drug or having any medical condition which might interact adversely with, or interfere with the action of, the study medication
- •The concomitant use of beta blockers
- •The consumption of grapefruit juice
- •Allergic to or has shown hypersensitivity to verapamil or agents similar to verapamil
- •Abuses opioids or has a history of significant drug or alcohol abuse within the past year as determined by investigator
- •Has participated in an investigational drug trial in the 30 days prior to the screening visit
- •Has liver or kidney disease
- •Has a cardiopathology contraindicating verapamil administration
- •Subjects with previous adynamic ileus.
- •Subjects with chronic cluster headache
- •Use of antipsychotic, antidepressants, lithium or other prophylactic treatment less than one month prior to inclusion
研究组 & 干预措施
R-verapamil 75 mg tablet
Active Comparator
375 mg/day; one in the morning, two in the afternoon and two at bedtime daily
干预措施: R-verapamil 75 mg tablet (Drug)
Placebo
Placebo Comparator
one in the morning, two in the afternoon and two at bedtime daily
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the average daily frequency of attacks
时间窗: 2 weeks
次要结局
- Change in the average daily frequency of attacks(1 week)
- Patient acceptability of treatment(2 weeks)
- Change in duration of attacks(2 weeks)
- Change in headache severity index(2 weeks)
- Change in Hit-6 disability score(2 weeks)
- R-verapamil and Placebo responders(2 weeks)
- Change in intensity of attacks(2 weeks)
- Change in consumption of abortive agents(2 weeks)
研究者
研究点 (1)
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