Nordic comparison of CGRP antibody plus onabotulinumtoxinA (Botox) versus CGRP antibody alone for chronic migraine
A Randomized Placebo-controlled Double-blind Phase III Trial to Investigate the Reduction of Monthly Migraine Days (MMDs) Over 12 Weeks of Treatment With CGRP mAbs and Onabotulinumtoxin A Intramuscularly Compared With CGRP mAbs and Placebo in Chronic Migraine
This trial will test whether adding onabotulinumtoxinA (Botox) to a CGRP monoclonal antibody reduces monthly headache days in adults with chronic migraine.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 6 sites (Grålum and 5 other locations) |
| Trial ID | NCT07040813 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults 18–70 years with chronic migraine per ICHD-3 who meet local indications for both CGRP monoclonal antibodies and onabotulinumtoxinA, have no prior use of either therapy, and can provide informed consent (women of childbearing potential must use highly effective contraception).
Not a fit: People with contraindications or allergies to onabotulinumtoxinA or CGRP antibodies, recent serious cardiovascular events, medication‑overuse headache, or prior use of CGRP inhibitors or BTA are unlikely to be eligible or to receive benefit.
Why it matters
Potential benefit: If successful, the combination could reduce monthly headache days and improve daily functioning and quality of life for people with chronic migraine.
How similar studies have performed: Several observational and pooled real-world analyses suggest a benefit from combining CGRP mAbs and BTA, but randomized controlled trials of this combination have not been conducted to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Grålum and 5 other locations
- 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)
- Oslo University Hospital — Oslo, Norway (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.