EUCTR2016-002211-18-ES进行中（未招募）1 期
A 12-week double-blind, randomized, multicenter study comparing the efficacy and safety of once monthly subcutaneous 70 mg AMG 334 against placebo in adult episodic migraine patients who have failed 2-4 prophylactic treatments (LIBERTY)
ovartis Farmacéutica S.A0 个研究点目标入组 246 人开始时间: 2016年8月24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
- 246
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
- •- Documented history of migraine (with or without aura) for >/= 12 months prior to screening according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3)
- •- 4 to 14 days per month of migraine symptoms (based on ICHD-3 criteria) on average across the 3 months prior to screening based on retrospective reporting
- •- <15 days per month of headache symptoms (ie migraine and non-migraine)
- •- Failed 2 to 4 prior migraine prophylaxis treatments out of the following: Propranolol/metoprolol, topiramate, flunarizine, valproate/divalproex, amitriptyline, venlafaxine, lisinopril, candesartan, locally approved products (e.g. oxeterone or pizotifen)
- •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 372
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- Older than 50 years of age at migraine onset
- •- Unable to differentiate migraine from other headaches
- •- History of cluster headache or hemiplegic migraine headache
- •- Failed more than 4 prior migraine prophylaxis treatments [as specified in protocol]
- •- Use of a prophylactic migraine medication within 5 half-lives, or a device or procedure within one month prior to the start of the baseline phase or during the baseline phase
- •- Prior Botulinum toxin A treatment in the head/neck region (including cosmetic use or other licensed indications for Botox ®) within 4 months prior to start of the baseline phase
- •- Use of the following for any indication in the 1 month prior to the start of the baseline phase or during the baseline phase:
- •o ergotamines or triptanes =10 days/month, or
- •o simple analgesics (NSAIDs, acetaminophen, paracetamol) =15 days/month, or
- •o opioid- or butalbital-containing analgesics =4 days/month
研究者
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