NCT07040813 The Nordic Chronic Migraine Trial of CGRP Monoclonal Antibody and Onabotulinumtoxin A Dual Therapy Compared to CGRP mAbs Monotherapy
| NCT ID | NCT07040813 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Oslo University Hospital |
| Condition | Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2025-06-06 |
| Primary Completion | 2029-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 450 participants in total. It began in 2025-06-06 with a primary completion date of 2029-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Migraine is characterized by attacks of throbbing, moderate or severe headache, often associated with nausea, vomiting, and/or sensitivity to light and/or sound. Chronic migraine, which occurs in 1-2 % of the population is characterized by 15 or more headache days/month for more than 3 months and at least 8 days/month with features of migraine headache. The study will evaluate the efficacy of onabotulinumtoxin A when added to CGRP monoclonal antibody therapy in chronic migraine prevention. Adverse events and change in disease activity will be monitored. Onabotulinumtoxin A and CGRP monoclonal antibody therapy are investigational drugs developed to prevent chronic migraine. Approximately 450 patients will be included from sites in Norway. All participants will receive CGRP monoclonal antibody therapy. Additionally, the participants will be randomized to receive onabotulinumtoxin A or placebo injections. Total study duration is 20 weeks including 3 on site visits and 3 telephone visits. After an inclusion visit the participants are registering data in an electronic headache diary using the application Brain Twin for a minimum of 4 weeks before the come to the randomization visit and the study medications are started. The duration of treatment is 12 weeks.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07040813 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07040813 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 450 participants.
Is NCT07040813 currently recruiting?
Yes, NCT07040813 is actively recruiting participants. Contact the research team at a.h.aamodt@medisin.uio.no for enrollment information.
Where is the NCT07040813 trial being conducted?
This trial is being conducted at Grålum, Norway, Kristiansand, Norway, Lillehammer, Norway, Oslo, Norway and 2 additional locations.
Who is sponsoring the NCT07040813 clinical trial?
NCT07040813 is sponsored by Oslo University Hospital. The trial plans to enroll 450 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.