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The Nordic Chronic Migraine Trial of CGRP monoclonal antibody and onabotulinumtoxin A dual therapy – a randomized-controlled double-blind trial (NorMig)
EU CTIS ID: 2024-517981-40-00
What this study is testing
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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 1.3. 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.
You likely can't join if
- 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
See the full eligibility criteria
- 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 1.3. 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.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.