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Taking peoplePhase 3

Tests two migraine medicines together in adults with chronic migraine

Tests a CGRP antibody with botulinum toxin injections in adults with chronic migraine.

Key facts

Who runs it
Oslo University Hospital HF
Where
Helsinki, FinlandSee the siteAlso in 1 other country, 12 sites
Registry title
The Nordic Chronic Migraine Trial of CGRP monoclonal antibody and onabotulinumtoxin A dual therapy – a randomized-controlled double-blind trial (NorMig)
Status
Recruiting
Phase
Phase 3
People taking part
550 people, planned
Started
6 Jun 2025
Expected to end
31 Jan 2029
Type of study
Interventional
Record updated
7 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. 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

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Finland

Also in 1 other country, 12 sites

  • Aava ja Pikkujaetti OyHelsinki, FinlandNot yet recruiting

About the trial

What the trial wants to find out

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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.
Plain-language title
Tests two migraine medicines together in adults with chronic migraineGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
7 October 2026