EUCTR2012-005331-90-SE进行中（未招募）1 期
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention
Amgen Inc.0 个研究点目标入组 483 人开始时间: 2013年5月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 483
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Adults = 18 to = 60 years of age upon entry into screening
- •- History of migraine (with or without aura) for = 12 months prior to screening according to the IHS Classification ICHD-II (Headache Classification Committee of the International Headache Society, 2004) based on medical records and/or patient self-report - Migraine frequency: = 4 and = 14 migraine days per month in each of the 3 months prior to screening - Headache (ie, migraine and non-migraine headache) frequency: < 15 headache days per month (with = 50% of the headache days being migraine days) in each of the 3 months prior to screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 468
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Older than 50 years of age at migraine onset
- •- History of cluster headache or hemiplegic migraine headache
- •- No therapeutic response with > 2 of the eight medication categories for prophylactic treatment of migraine after an adequate therapeutic trial ( refer to criterion 4.2.5 in the protocol) - Used a prohibited medication, device or procedure prior to the start of the baseline phase (Refer to Section 6.4 of the protocol for the list of these excluded treatments and the timeframes prior to the start of the baseline phase)
- •- Received botulinum toxin in the head and/or neck region within 6 months prior to the start of the baseline phase
- •- Taken the following for any indication in any month during the 3 months prior to the start of the baseline phase:
- •Ergotamines or triptans on = 10 days per month, or
- •Simple analgesics (nonsteroidal anti-inflammatory drugs [NSAIDs], acetaminophen) on = 15 days per month, or
- •Opioid- or butalbital-containing analgesics on = 3 days per month - History or evidence of unstable or clinically significant medical condition including but not limited to the following:
- •Chronic pain syndromes (eg, fibromyalgia, chronic back pain, chronic pelvic pain)
- •History of major psychiatric disorder, or current evidence of depression based on a Beck Depression Inventory (BDI)-II total score > 24 at screening.
- •- Female subject of childbearing potential who is unwilling to use an acceptable method of effective contraception during treatment with investigational product through 12 weeks after the last dose of investigational product if receiving AMG 334 70 mg, and 16 weeks after the last dose of investigational product if receiving AMG 334 140 mg.
- •- Currently receiving treatment in another investigational device or drug study, or less than 90 days prior to screening since ending treatment on another investigational device or drug study(-ies)
研究者
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