EUCTR2014-004464-38-NL进行中（未招募）1 期
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention - STRIVE study
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
- 852
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
- •Criteria to be assessed prior to entering the subject into the initial screening phase and/or baseline phase:
- •Adults = 18 to = 65 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-3 based on medical records and/or patient self-report
- •Migraine frequency: = 4 and < 15 migraine days per month on average across the 3 months prior to screening
- •Headache (ie, migraine and non-migraine headache) frequency: < 15 headache days per month on average across the 3 months prior to screening
- •Criteria to be assessed during the baseline phase and confirmed prior to randomizing the subject into the double-blind treatment phase:
- •Migraine frequency: = 4 and < 15 migraine days during the baseline phase based on the eDiary calculations
- •Headache frequency: < 15 headache days during the baseline phase based on the eDiary calculations
- •Demonstrated at least 80% compliance with the eDiary
- •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 852
- •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
- •Unable to differentiate migraine from other headaches
- •No therapeutic response with > 2 of the following 7 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial. These medication categories are:
- •- Category 1: Divalproex sodium, sodium valproate
- •- Category 2: Topiramate
- •- Category 3: Beta blockers
- •- Category 4: Tricyclic antidepressants
- •- Category 5: Serotonin-norepinephrine reuptake inhibitors
- •- Category 6: Flunarizine, verapamil
- •- Category 7: Lisinopril, candesartan
- •Used a prohibited medication, device, or procedure within 2 months prior to the start of the baseline phase or during the baseline phase
- •Received botulinum toxin in the head and/or neck region within 4 months prior to the start of the baseline phase or during the baseline phase
- •Taken the following for any indication in any month during the 2 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 = 4 days per month
- •Anticipated to require any excluded medication, device, or procedure during the study
- •Active chronic pain syndromes (such as fibromyalgia and chronic pelvic pain)
- •History of major psychiatric disorder (such as schizophrenia and bipolar disorder), or current evidence of depression based on a Beck Depression Inventory (BDI)-II total score > 19 at screening. Subjects with anxiety disorder and/or major depressive disorder are permitted in the study if they are considered by the investigator to be stable and are taking no more than 1 medication for each disorder. Subjects must have been on a stable dose within the 3 months prior to the start of the baseline phase.
- •History of seizure disorder or other significant neurological conditions other than migraine. Note: A single childhood febrile seizure is not exclusionary.
- •Malignancy within the 5 years prior to screening, except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ
- •Human immunodeficiency virus (HIV) infection by history
- •Hepatic disease by history or total bilirubin = 2.0 x ULN or alanine transaminase (ALT) or aspartate aminotransferase (AST) = 3.0 x ULN, as assessed by the central laboratory at initial screening
- •Myocardial infarction (MI), stroke, transient ischemic attack (TIA), unstable angina, or coronary artery bypass surgery or other revascularization procedure within 12 months prior to screening
- •History or evidence of any other unstable or clinically significant medical condition, that in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- •Subject has any clinically significant vital sign, laboratory, or ECG abnormality during screening that, in the opinion of the investigator, could pose a risk to subject safety or interfere with the study evaluation
- •The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior or endorsing items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) assessed at screening
- •Evidence of drug or alcohol abuse or dependence within 12 months prior to screening, based on medical records, patient self-report, or positive urine
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