EUCTR2017-000630-57-DE进行中（未招募）1 期
A Phase 2a Randomized Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention.
Amgen Inc.0 个研究点目标入组 335 人开始时间: 2017年7月4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
- 335
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
- •Subjects are eligible to be included in the baseline period of the study only if all of the following criteria apply:
- •-Subject or subject’s legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.
- •-Subject has provided informed consent prior to any study-specific
- •activities/procedures being initiated
- •-Adults = 18 to = 60 years of age at the time of signing the informed consent form.
- •-History of migraine (with or without aura) for = 12 months before screening according to the International Headache Society (IHS) Classification ICHD-III based on medical records and/or patient self-report.
- •-Migraine frequency: = 4 migraine days per month on average across the 3 months before screening
- •-Failed at least 1 medication for prophylactic treatment of migraine due to tolerability or lack of efficacy as determined by the investigator, after an adequate therapeutic trial at a dose that is used in the prevention of migraine
- •-Must meet 1 of the following acute migraine-specific treatment criteria:
- •1. currently taking triptans or ergotamines as acute migraine treatment (within the last month)
- •2. had previously responded to triptans or ergotamines but had to discontinue due to intolerance
- •3. unable to take triptans or ergotamines as acute migraine treatments due to contraindications
- •-Must meet the one of the following migraine criteria:
- •CM is defined as:
- •= 15 headache days of which = 8 headache days meet criteria as migraine days during the baseline period based on the electronic diary (eDiary) calculations
- •EM is defined as:
- •< 15 headache days of which at least 4 or more headache days meet criteria as migraine days during the baseline period based on the eDiary calculations
- •-Demonstrated at least 80% compliance with the eDiary (for example, completing eDiary items for at least 23 out of 28 days during the baseline period)
- •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 335
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects are excluded from the study and the baseline period if any of the following criteria apply:
- •Disease Related
- •-Older than 50 years of age at migraine onset.
- •-History of cluster headache, hemiplegic migraine headache
- •-Unable to differentiate migraine from other headaches
- •-Migraine with continuous pain, in which the subject does not experience any pain-free periods (of any duration) during the 1 month before the screening period
- •Other Medical Conditions
- •-Currently diagnosed with chronic pain syndromes (eg, fibromyalgia, chronic back pain, 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 II (BDI-II) total score > 19 at screening. Subjects with anxiety disorder and/or major depressive disorder are permitted in the study if the investigator considers the subject to be stable (with BDI-II = 19) and are taking no more than 1 medication for each disorder. Subjects must have been on a stable dose within the 2 months before the start of the baseline period.
- •-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 before screening, except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ.
- •-Known human immunodeficiency virus infection by history
- •-Hepatic disease by history or total bilirubin = 1.5 x upper limit of normal (ULN) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 2.0 x ULN, as assessed by the central laboratory at screening.
- •-Glycosylated hemoglobin (HbA1c) = 6.0% at screening
- •-Serum plasma glucose level = 100 mg/dL at screening; ideally performed while fasting
- •-History of diabetes mellitus or history of impaired fasting glucose
- •-Body mass index (BMI) = 18.0 or = 40 at screening
- •-Poorly controlled hypertension (systolic blood pressure 150 mmHg and/or diastolic blood pressure 90 mmHg or greater)
- •-Myocardial infarction, stroke, transient ischemic attack, unstable angina, or coronary artery bypass surgery or other revascularization procedure within 12 months before 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 electrocardiogram (ECG) abnormality during screening that, in the opinion of the investigator, could pose a risk to subject safety or interfere with the study evaluation
- •-Subject has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening.
- •-Evidence of drug or alcohol abuse or dependence within 12 months before screening, based on medical records, subject self-report, or positive urine drug test performe
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