2024-517981-40-00RecruitingPhase 3
The Nordic Chronic Migraine Trial of CGRP monoclonal antibody and onabotulinumtoxin A dual therapy – a randomized-controlled double-blind trial (NorMig)
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.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 7 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 550 (estimated)
- First submitted
- 24 Jan 2025
- Start date
- 6 Jun 2025
- Lead sponsor
- Oslo University Hospital HF
- Diseases
- Migraine
- EU CT number
- 2024-517981-40-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 550
- 13 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18-70 with chronic migraine who have never used CGRP inhibitors or onabotulinumtoxin A (BTA).
- Age
- 18-70 years
- Sex
- People of any sex can join.
- Disease stage
- Chronic migraine, as defined by the International Classification of Headache Disorders version 3 (criteria 1.3). Treatment with CGRP mAbs and BTA must be indicated according to their product information (SmPC).
- Earlier treatment
- No previous use of CGRP inhibitors or BTA. Overuse of pain medicine causing headache must have been treated by stopping the drug.
Main reasons for not taking part
- Allergy or other reason not to take BTA or CGRP mAbs, including serious heart or blood vessel disease such as heart attack or stroke in the last 12 months
- Pregnant, planning pregnancy, breastfeeding or unable to use contraception
- Headache every day for more than 1 year with no headache-free days or periods
- Alcohol or illicit drug dependence
- Joined another study of a new drug or prescription medicine within 2 months before inclusion
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Age
- Long-standing continuous headache with no headache free days or periods for a period oftime >1 years
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aava ja Pikkujaetti Oy | Helsinki | Finland | Not yet recruiting |
| Helse Moere Og Romsdal HF | Aalesund | Norway | Recruiting |
| Helse Bergen HF | Bergen | Norway | Recruiting |
| Sykehuset Innlandet HF | Brumunddal | Norway | Recruiting |
| Sykehuset Oestfold HF Kalnes | Graalum | Norway | Recruiting |
| Sorlandet Sykehus HF | Kristiansand S | Norway | Recruiting |
| Helse Nord-Trondelag HF | Namsos | Norway | Recruiting |
| Oslo University Hospital HF | Oslo | Norway | Recruiting |
| Oslo Hodepinesenter AS | Oslo | Norway | Recruiting |
| Sykehuset Telemark HF | Skien | Norway | Recruiting |
| Helse Stavanger HF | Stavanger | Norway | Recruiting |
| Universitetssykehuset Nord-Norge HF | Tromsoe | Norway | Recruiting |
| St. Olavs hospital HF | Trondheim | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.