NCT07040813RecruitingPhase 3
The Nordic Chronic Migraine Trial of CGRP Monoclonal Antibody and Onabotulinumtoxin A Dual Therapy Compared to CGRP mAbs Monotherapy
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
Source: ClinicalTrials.gov · Last updated 27 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 450 (estimated)
- First submitted
- 18 Jun 2025
- Start date
- 6 Jun 2025
- Primary completion date
- 31 Jan 2029
- Lead sponsor
- Oslo University Hospital
- Diseases
- Migraine
- NCT number
- NCT07040813
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 450
- From 6 Jun 2025 to the primary completion date, 31 Jan 2029
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov 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.
- 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.
- 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.
Age
- Long-standing continuous headache with no headache free days or periods for a period of time \>1 years.
Other
- 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.
- Inability to understand study procedures and to comply with them for the entire length of the study, assessed at the discretion of the investigator.
Who the study is looking for
- Informed and signed written consent.
- 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 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Østfold Hospital Trust Coordinator of this site? Confirm its status | Grålum | Norway | Not yet recruiting |
| Sørlandet Hospital Kristiansand Coordinator of this site? Confirm its status | Kristiansand | Norway | Not yet recruiting |
| Innlandet Hospital Trust Lillehammer Coordinator of this site? Confirm its status | Lillehammer | Norway | Not yet recruiting |
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Telemark Hospital Trust Skien Coordinator of this site? Confirm its status | Skien | Norway | Not yet recruiting |
| St. Olav University Hospital Coordinator of this site? Confirm its status | Trondheim | Norway | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.