2024-517981-40-00招募中3 期
A randomized placebo-controlled double-blind phase III two-arm study to investigate the reduction of Monthly Migraine Days (MMDs) over 12 weeks of treatment with combination of CGRP mAbs and onabotulinumtoxin A intramuscularly compared with CGRP mAbs and placebo in male and female participants with chronic migraine aged 18-70 years.
Oslo University Hospital HF12 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2025年5月13日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 12
- 主要终点
- Reduction of Monthly Migraine Days (MMDs) over 12 weeks of treatment with the study medication
研究概览
简要总结
To assess the efficacy of dual therapy with CGRP mAbs and BTA compared to single therapy with CGRP mAbs in chronic migraine patients measured by reduction of Monthly Migraine Days (MMDs) over 12 weeks of treatment
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Informed and signed written consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •Individuals of any sex, 18-70 years at the time of signing the informed consent.
- •Fulfilling the diagnosis chronic migraine criteria 1.
- •according to the International Classification of Headache Disorders version 3 at the time of inclusion.
- •Indications for treatment with CGRP mAbs according to SmPCs
- •Indications for treatment with BTA according to SmPC.
- •No previous use of CGRP inhibitors or BTA.
- •Women of childbearing potential (WOCBP) can only be included if they use a highly effective contraception method as defined in Appendix 4 of the protocol.
排除标准
- •Contraindications, allergy or hypersensitivity reactions to BTA including infection at the injection site.
- •Investigators may exclude patients who, for various reasons (for example, severe psychiatric disorders), are considered unlikely to be able to complete the tasks required for participation in the study.
- •Inability to understand study procedures and to comply with them for the entire length of the study, assessed at the discretion of the investigator.
- •Contraindications, allergy or hypersensitivity reactions to CGRP mAbs including serious cardiovascular illness such as myocardial infarction, stroke, unstable angina pectoris, revascularization procedures last 12 months.
- •Concomitant medication overuse headache where drug withdrawal has not been done.
- •Subject is unable to differentiate migraine from other concomitant headaches
- •Participation in a clinical study of a new chemical entity or a prescription medicine within 2 months before study inclusion (Visit 2).
- •Long-standing continuous headache with no headache free days or periods for a period oftime >1 years
- •Pregnancy, planning to get pregnant, inability to use contraceptives and lactating.
- •High degree of comorbidity and/or frailty associated with reduced life expectancy or high likelihood of hospitalization, at the discretion of the investigator
- •Alcohol or illicit drug dependence.
结局指标
主要结局
Reduction of Monthly Migraine Days (MMDs) over 12 weeks of treatment with the study medication
Reduction of Monthly Migraine Days (MMDs) over 12 weeks of treatment with the study medication
次要结局
- Reduction of Monthly Headache Days (MHDs) over 12 weeks of treatment with the study medication
- Monthly number of days with rescue medication over 12 weeks of treatment with the study medication.
- Number of treatment responders (≥ 50%, ≥75% and 100 % reduction in MHD and MMDs over 12 weeks of treatment) at 12 weeks post-randomisation.
- Number of weekly migraine days from baseline to 12 months post-randomization.
- Total number of hours at moderate or severe pain over 12 weeks of treatment.
- Number of treatment responders (≥ 30% reduction in mean MHDs over 12 weeks of treatment) at 12 weeks post-randomization.
- Number of crystal-clear headache-free days after 12 weeks of treatment with the study medication.
- Percentage of patients fulfilling the ICHD-3 diagnostic criteria for MOH over 12 weeks of treatment.
- Number of patients completing the trial and number of dropouts.
- Change in MIDAS over 12 weeks of treatment with the study medication.
- Change in HADS-A and HADS-D score over 12 weeks of treatment with the study medication.
- Change in Bergen Insomnia Scale over 12 weeks of treatment with the study medication
- Change in Fatigue Score over 12 weeks of treatment with the study medication
- Change in Mig-SCOG score over 12 weeks of treatment with the study medication
- PGIC sum
- Number of days on sick leave from baseline to 12 weeks post-randomization.
- • Number of treatment related adverse events (AEs) and treatment related serious adverse events (SAEs) over 12 weeks of treatment.
- Costs and Quality of life measured by EQ-5D-5L before treatment initiation, and 12 weeks after treatment initiation
- Absenteeism from work (salary, sick leave, social security). Presenteeism (lost workplace productivity), Productivity Cost
- Treatment duration and dose intensity for trial treatments, adverse events (eCRF). Type and frequency of physician visits, emergency departments, general practitioner visits, hospitalizations. Other related resource use, including pharmaceuticals, transport, and time.
研究者
Rikshospitalet, Oslo University Hospital
Scientific
Oslo University Hospital HF
研究点 (12)
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