Nordic comparison of CGRP antibody plus onabotulinumtoxinA (Botox) versus CGRP antibody alone for chronic migraine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled Phase 3 trial enrolls about 450 adults with chronic migraine across sites in Norway and compares add-on onabotulinumtoxinA injections to placebo on top of standard CGRP monoclonal antibody therapy. All participants receive a CGRP monoclonal antibody and are randomized to receive either onabotulinumtoxinA or placebo injections, with safety and adverse events monitored throughout. The total study duration is about 20 weeks and includes three on-site visits and three telephone visits. Endpoints include change in monthly headache days plus measures of fatigue, cognitive symptoms, quality of life, and health economic outcomes.

Why it matters

Who can join: the full rules

Inclusion criteria

1. Informed and signed written consent.
2. Individuals of any sex, 18-70 years at the time of signing the informed consent.
3. Fulfilling the diagnosis chronic migraine criteria 1.3. according to the International Classification of Headache Disorders version 3 at time of inclusion.
4. Indications for treatment with CGRP mAbs according to SmPCs.
5. Indications for treatment with BTA according to SmPC.
6. No previous use of CGRP inhibitors or BTA.
7. Women of childbearing potential (WOCBP) can only be included if they use a highly effective contraception method

Exclusion criteria:

1. Contraindications, allergy or hypersensitivity reactions to BTA including infection at the injection site.
2. 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.
3. Concomitant medication overuse headache where drug withdrawal has not been done.
4. Subject is unable to differentiate migraine from other concomitant headaches.
5. Participation in a clinical study of a new chemical entity or a prescription medicine within 2 months before study inclusion (Visit 2).
6. Long-standing continuous headache with no headache free days or periods for a period of time \>1 years.
7. Pregnancy, planning to get pregnant, inability to use contraceptives and lactating.
8. High degree of comorbidity and/or frailty associated with reduced life expectancy or high likelihood of hospitalization, at the discretion of the investigator.
9. Alcohol or illicit drug dependence.
10. 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.
11. Inability to understand study procedures and to comply with them for the entire length of the study, assessed at the discretion of the investigator.

Where it's running

• Oslo University Hospital
  Oslo, Norway Recruiting
• Østfold Hospital Trust
  Grålum, Norway Not yet recruiting
• Sørlandet Hospital Kristiansand
  Kristiansand, Norway Not yet recruiting
• Innlandet Hospital Trust Lillehammer
  Lillehammer, Norway Not yet recruiting
• Telemark Hospital Trust Skien
  Skien, Norway Not yet recruiting
• St. Olav University Hospital
  Trondheim, Norway Not yet recruiting

Study contacts

• Study coordinator: Anne Hege Aamodt, Prof, MD, PhD
• Email: a.h.aamodt@medisin.uio.no
• Phone: +47 95867270

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Analyzing CGRP Levels in Migraine Patients by Age and Sex

  This study looks at the levels of a substance linked to migraines in people with migraines and healthy individuals to see how age and sex might affect treatment responses.

  Recruiting Hospital Universitari Vall d'Hebron Research Institute · Barcelona, Barcelona · NCT06674772

• MMA Embolization for Migraine: Patient-Reported Outcomes from a Single Site

  This registry tests whether adults with migraine who have or plan to have middle meningeal artery embolization notice changes in headaches and quality of life over time.

  Recruiting Cortex Neurovascular · Tacoma, Washington · NCT07652034

• Bilateral middle meningeal artery embolization for refractory chronic migraine

  This study will try blocking both middle meningeal arteries with Onyx in adults who have refractory bilateral chronic migraine to see if it is safe and lowers headaches.

  Recruiting Johns Hopkins University · Baltimore, Maryland · NCT07223008

• Real-world use of anti-CGRP medicines for preventing migraine

  This project will follow people with episodic or chronic migraine who start anti-CGRP medicines to see if the treatments reduce migraine frequency and side effects over two years.

  Recruiting at 25 sites Hospital Universitari Vall d'Hebron Research Institute · Miami, Florida and 25 other locations · NCT07159750

• New methods to test preventive migraine treatment

  This trial will test how the active medicine, placebo injections, and the information given about them affect symptoms in adults with chronic migraine.

  Recruiting at 2 sites University of Aarhus · Aarhus C, Denmark and 1 other locations · NCT07071506

• Remote electrical neuromodulation to test pain inhibition in migraine and fibromyalgia

  We’re testing if the Nerivio wearable can boost the body’s natural pain-inhibition system (CPM) and reduce pain more than a sham device in adults with migraine or fibromyalgia.

  Recruiting Theranica · Bridgewater, New Jersey and 1 other locations · NCT07841509

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.