EUCTR2018-003342-16-PT进行中（未招募）1 期
A Phase 4, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Chronic Migraine and Medication Overuse Headache
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 620
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
- •101 Subject has provided informed consent prior to initiation of any study-specific activities/procedures
- •102 Age = 18 years on entry into the study
- •103 Documented history of migraine without aura and/or migraine with aura according to the ICHD-3 Classification for = 12 months at screening
- •104 Documented history of CM for a minimal duration of 6 months before screening
- •105 Current diagnosis of MOH
- •106 History of treatment failure with at least 1 preventive treatment as defined as treatment discontinuation due to lack of efficacy, adverse event or general poor tolerability
- •107. = 14 headache days during the 28-day baseline period out of which = 8 headache days meet criteria as migraine days
- •108 Observation of acute migraine medication overuse during baseline. Medication overuse at baseline is defined as:
- •- = 10 days of combination treatment OR
- •- = 10 days of short-acting opioids/opioid-containing medication OR
- •- = 10 days of triptans, ergots, OR
- •- = 15 days of NSAIDs or simple analgesics intake
- •110 At least 2 acute headache medication days per week for each week with at least 5 diary days
- •111 Demonstrated at least 80% compliance with the eDiary (eg, must complete eDiary items on at least 23 out of 28 days during the baseline phase)
- •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 480
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 207
排除标准
- •201 Age > 50 years at migraine onset or > 65 years at CM onset
- •202 History of hemiplegic migraine, cluster headache or other trigeminal autonomic cephalalgia
- •203 Current concomitant diagnosis of a secondary type of headache other than MOH
- •204 History of clinically significant orofacial pain (eg, painful cranial neuropathies, temporomandibular disorder) that in the opinion of the investigator or Amgen's physician, if consulted, could interfere with the study evaluation, procedures or
- •205 Chronic headache with continuous pain, in which the subject does not experience headache-free periods of any duration
- •206 No therapeutic response in prevention of migraine after an adequate therapeutic trial of > 3 of the following medication categories. These medication categories include:
- •- Category 1: Topiramate
- •- Category 2: Other antiepileptics (eg, divalproex sodium, sodium
- •valproate, carbamazepine)
- •- Category 3: Beta blockers
- •- Category 4: Tricyclic antidepressants
- •- Category 5: Serotonin-norepinephrine reuptake inhibitors, selective
- •serotonin-reuptake inhibitors and other antidepressants
- •- Category 6: Calcium channel blockers (eg, verapamil, amlodipine) or
- •calcium antagonists (eg, flunarizine)
- •- Category 7: Angiotensin receptor blockers (eg, candesartan) or
- •angiotensin-converting enzyme (ACE) inhibitors (eg, lisinopril)
- •- Category 8: Botulinum toxin
- •- Category 9: Other centrally acting drugs used for migraine prophylaxis
- •(eg, pizotifen)
- •235. Changes in drug regimen (ie, changes in dose or frequency of use) of an allowed migraine preventive medication within 2 months prior to
- •start of baseline
- •208 Received botulinum toxin in the head and/or neck region within 4 months prior to screening
- •236. Documented history of treatment with an anti-CGRP preventive treatment
- •210 Anticipated to require any excluded medication/device or procedure during the study
- •211 Subject likely to not be available to complete all protocol required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments [COAs]) to the best of the subject’s and investigator's knowledge
- •212 History or evidence of unstable or clinically significant medical condition that, in the opinion of the investigator or Amgen's physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or
- •completion.
研究者
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