EUCTR2013-001707-36-NO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 Chronic Migraine Prevention
Amgen Inc.0 个研究点目标入组 490 人开始时间: 2013年11月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 490
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 at least 5 attacks of migraine without aura and/or migraine with visual,
- •sensory, speech and/or language, retinal or brainstem aura according to the IHS Classification ICHD-III (Headache Classification Committee of the International
- •Headache Society, 2013) based on medical records and/or patient self-report
- •- History of = 15 headache days per month of which = 8 headache days were
- •assessed by the subject as migraine days per month 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 490
- •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
- •- Chronic migraine with continuous pain, in which the subject does not experience any pain free periods (of any duration) during the 1 month prior to screening
- •- Taken an opioid and/or opioid-containing analgesic for any indication on greater than 6 days during the 3 months prior to screening
- •- Taken a butalbital-containing analgesic for any indication on greater than 6 days during the 3 months prior to screening
- •- No therapeutic response in prophylaxis of migraine after an adequate therapeutic trial to > 3 of the medication categories (detailled in the protocol)
- •- Used a prohibited migraine prophylactic medication, device or procedure within 2 months prior to the start of the baseline phase (Refer to Section 6.5 for the list
- •of excluded medications, devices and procedures)
- •- Changing the dose of a concomitant medication that is not prescribed for migraine prophylaxis but that may have migraine prophylaxis effects within 1 month prior to screening. (Refer to Section 6.4 and Section 6.5 for the list of these medications)
- •- Received botulinum toxin in the head and/or neck region within 4 months prior to Screening
- •- History or evidence of unstable or clinically significant medical condition including but not limited to the following:
- •· Currently diagnosed with fibromyalgia, and/or 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.
- •· History of seizure disorder or other significant neurological conditions other than migraine
- •· Poorly controlled hypertension (systolic blood pressure [BP] 150 mm Hg and/or diastolic BP 90 mm Hg or greater)
- •· Myocardial infarction (MI), stroke, transient ischemic attack (TIA), unstable angina, coronary artery bypass surgery or other revascularization procedure within 12 months prior to screening
- •- Female subject of childbearing potential who is unwilling to use an acceptable method of effective contraception during treatment with AMG 334 through 16 weeks after the last dose of investigational product.
- •- Currently receiving treatment in another investigational device or drug study, or less than 90 days since ending treatment on another investigational device or drug study(-ies)
研究者
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