EUCTR2021-006219-28-AT进行中（未招募）1 期
MR-Spectroscopy: Investigating neurochemical changes in brain metabolism in migraineurs before and after CGRPAntibody treatment – a randomized, controlled, open-label trial
Medical University Innsbruck0 个研究点目标入组 38 人开始时间: 2022年1月14日最近更新:
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
- 入组人数
- 38
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
- •Written informed consent must be obtained before any assessment is performed
- •Adults > 18 and < 65 of age upon entry into screening
- •Documented history of migraine with or without aura >12 months prior to screening according to the International Classification of Headache
- •Disorders-3rd Edition (ICHD-3)
- •Migraine frequency = 1 and = 15 migraine days per month across the 3 months prior to screening based on retrospective reporting.
- •Subject has not received a CGRP mAB for migraine prophylaxis in the past.
- •Subject can differentiate migraine from other headaches
- •Lack of contraindication for MRI
- •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 38
- •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.
- •Exposure to botulinum toxin in the head and/or neck region within 4 months prior to the start of the baseline period, during the baseline period, or
- •treatment period.
- •Traditional medications and/or procedures are not allowed if not used at a stable dose/frequency for at least 3 months prior to randomization and
- •during the study.
- •Active chronic pain syndromes (e.g., fibromyalgia, chronic pelvic pain).
- •History of major psychiatric disorders (such as schizophrenia or bipolar disorder) or current evidence of depression.
- •History of seizure disorder or other significant neurological conditions other than migraine.
- •History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated,
- •within the past 5 years
- •Human immunodeficiency virus (HIV) infection by history.
- •History or evidence of any other unstable or clinically significant medical condition.
- •Subject has any clinically significant vital sign during screening that, in the opinion of the investigator, could pose a risk to subject safety or interfere with the study evaluation.
- •Coronary artery disease, myocardial infarction, stroke, transient ischemic attack, stable or unstable angina pectoris, carotid or vertebro-basilar
- •artery disease, other cerebrovascular conditions (e.g.: AV malformation, aneurysm)
- •Evidence of drug or alcohol abuse or dependence in the past, based on medical records, patient self-report.
- •Pregnant or nursing (lactating) women
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of
- •contraception during dosing with study treatment.
- •Use of other investigational drugs within 5 half-lives of enrollment, or until the expected pharmacodynamic effect has returned to baseline,
- •whichever is longer.
- •History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
- •Previous exposure to Fremanezumab 225mg monthly or 675mg quarterly or exposure to any other prophylactic CGRP-targeted therapy (prior to and
- •during the study).
- •Unlikely to be able to complete all protocol required study procedures to the best of the subject’s and investigator’s knowledge
- •Taken the following for any indication during 2 months prior to screening:
- •-Ergotamines or triptans on =10 days per month, or
- •-NSAIDs, acetaminophen on =15 days per month, or
- •-Opioid-containing analgesics on =4 days per month
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