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2017年6月30日

概览

暂无简介。

注册库

who.int

开始日期

2017年6月30日

结束日期

待定

最后更新

7年前

研究类型

Interventional clinical trial of medicinal product

发起方

•Subjects are eligible to be included in the baseline period of the study only if all of the following criteria apply:
•\-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

•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.