EUCTR2018-003342-16-ES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
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
- 687
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
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 458
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 229
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)
- •207 Changes in drug regimen (ie, changes in dose or frequency of use) of an allowed migraine preventive medication within 2 months from baseline OR change in drug regimen of a medication with potential for migraine prevention within 2 months from baseline
- •208 Received botulinum toxin in the head and/or neck region within 4 months prior to screening
- •209 Documented history of treatment with an anti-CGRP product
- •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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