The Nordic Chronic Migraine Trial of CGRP monoclonal antibody and onabotulinumtoxin A dual therapy – a randomized-controlled double-blind trial (NorMig)
Key facts
- Where
- Aalesund, Bergen, Brumunddal, Graalum, Kristiansand S, Namsos, Oslo, Skien, Stavanger, Tromsoe és Trondheim, NorvégiaSee the 12 sites
- Phase
- 3. fázis
Where in Norvégia
- Helse Moere Og Romsdal HFAalesund, NorvégiaTaking people
- Helse Bergen HFBergen, NorvégiaTaking people
- Sykehuset Innlandet HFBrumunddal, NorvégiaTaking people
- Sykehuset Oestfold HF KalnesGraalum, NorvégiaTaking people
- Sorlandet Sykehus HFKristiansand S, NorvégiaTaking people
- Helse Nord-Trondelag HFNamsos, NorvégiaTaking people
- Oslo Hodepinesenter ASOslo, NorvégiaTaking people
- Oslo University Hospital HFOslo, NorvégiaTaking people
- Sykehuset Telemark HFSkien, NorvégiaTaking people
- Helse Stavanger HFStavanger, NorvégiaTaking people
- Universitetssykehuset Nord-Norge HFTromsoe, NorvégiaTaking people
- St. Olavs hospital HFTrondheim, NorvégiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Oslo University Hospital HF
- Trial code
- EU 2024-517981-40-00
- Record updated
- 2026. október 7.
- Original description
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 treatmentRead full original descriptionShow less
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.
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
Inclusion: 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.
Exclusion: 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); Alcohol or illicit drug dependence; 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; 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; Long-standing continuous headache with no headache free days or periods for a period oftime >1 years; Inability to understand study procedures and to comply with them for the entire length of the study, assessed at the discretion of the investigator; 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.