NCT00567086已完成2 期
A Double-Blind, Placebo-Controlled, Parallel Group Multicenter Study to Assess the Safety, Tolerance and Efficacy of a Single Subcutaneous Dose of TEZAMPANEL in Patients With Acute Migraine
TorreyPines Therapeutics1 个研究点 分布在 1 个国家目标入组 306 人开始时间: 2006年10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
- 已完成
- 发起方
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- Headache pain intensity, associated symptoms, functional response questionnaires, time to meaningful pain relief.
研究概览
简要总结
To evaluate the effects of a single sc administration of TEZAMPANEL at one of three different dosage levels compared to placebo, employing traditional measures of efficacy and safety in the treatment of a single episode of acute migraine.
详细描述
Primary:
• Headache relief (headache response) defined as the percentage of patients in each treatment group who experience a decrease in pain from moderate or severe intensity pre-dose (baseline) to mild or no pain 2 hours after study drug administration and prior to use of rescue medication.
Secondary:
- Percentage of patients in each treatment group who are pain-free two hours after study drug administration, prior to the use of any rescue medication
- Sustained headache response rate (percentage of patients in each treatment group with headache response at Hour 2 and no rescue medication or headache recurrence from 2 through 24 hours)
- Sustained pain-free rate (percentage of patients in each treatment group who are pain free at Hour 2 with no rescue medication or headache recurrence from 2 through 48 hours)
- Recurrence rate (percentage of patients in each treatment group with an Hour 2 mild response or pain-free response who subsequently develop a headache rated as moderate to severe in intensity within 2 to 24 hours)
- Relapse rate (percentage of patients in each treatment group with an Hour 2 pain free response who subsequently develop a headache rated as moderate to severe in intensity within 2 to 48 hours
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet all of the following inclusion criteria at screening should be considered for admission to the study:
- •Males and females aged 18 to 65 years, inclusive.
- •a. Females of childbearing potential must not be at risk for pregnancy during the study.
- •Patients must meet IHS diagnostic criteria for migraine, with or without aura.
- •Patients should have a history of 1 to 6 acute migraine headache attacks per month and 1 migraine headache within the past 30 days.
- •Patients should have at least a 1-year history of migraine headaches.
- •Patients should have been ≤ 50 years of age at initial migraine onset.
- •Patients must be able to distinguish migraine headaches as discreet headaches from other headaches, such as tension-type headaches. Additionally, patients should experience at least 48 hours of freedom from headaches between migraine attacks.
- •Patients must have a complete medical history (including headache history), ECG, and a PE at screening including formal assessments of visual acuity (Snellen chart) and visual field integrity visit.
- •Patients must be able to comprehend and satisfactorily comply with the protocol requirements, in the opinion of the investigator.
排除标准
- •Patients who meet any of the following exclusion criteria at screening will not be eligible for participation in the study.
- •Patients who also suffer from concomitant frequent, non-migraine headaches ≥6 days/month or who suffer frequent migraine as defined by an average of >6 attacks per month.
- •Patients who fail to present with a migraine attack for treatment within 30 days of screening.
- •Patients who have menstrual migraines: migraine attacks occur from days -2 through +3 (Day 1 is the first day of menstruation) of the menses but do not occur the rest of the month.
- •Patients who have clinically significant active or unstable systemic, renal, hepatic, gastrointestinal, neurological, endocrine, metabolic, or psychiatric disease as determined by medical history and physical examination. Patients who are breast-feeding are excluded. Patients with a history of cardiovascular illness, such as ischemic stroke, ischemic heart disease, Prinzmetal's angina, and hypertension are excluded.
- •Patients who have received any experimental drugs within one month prior to and one month subsequent to screening.
- •Patients who have taken a MAOI within 14 days prior to randomization
- •Patients who are allergic or have shown hypersensitivity to compounds with similar pharmacology to TEZAMPANEL.
- •Patients who have met the DSM-IV-TR criteria for any significant psychoactive substance use disorder (abuse, dependence, and/or withdrawal) within the past 90 days.
- •Patients who have a clinically significant abnormal laboratory test result at screening.
- •Patients who have a clinically notable vital sign abnormality at screening.
- •Patients will be excluded if 2 consecutive urine drug screenings are positive.
- •Patients will be excluded if there is evidence of a visual field disturbance.
- •Patients who have participated in a previous TEZAMPANEL (NGX424 or LY293558) study.
研究组 & 干预措施
A
Placebo Comparator
干预措施: TEZAMPANEL (Drug)
B
Experimental
干预措施: TEZAMPANEL (Drug)
C
Experimental
干预措施: TEZAMPANEL (Drug)
D
Experimental
干预措施: TEZAMPANEL (Drug)
结局指标
主要结局
Headache pain intensity, associated symptoms, functional response questionnaires, time to meaningful pain relief.
时间窗: 4 Hours
次要结局
未报告次要终点
研究者
研究点 (1)
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