The Nordic Chronic Migraine Trial of CGRP Monoclonal Antibody and Onabotulinumtoxin A Dual Therapy Compared to CGRP mAbs Monotherapy
Recruiting · NCT07040813 · Interventional (participants receive a specific treatment) · Lead sponsor: Oslo University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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.
- 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).
- Long-standing continuous headache with no headache free days or periods for a period of time \>1 years.
- 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.
- Alcohol or illicit drug dependence.
- 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.
- 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 is running
6 locations listed.
- Østfold Hospital Trust - Grålum, Norway
- Sørlandet Hospital Kristiansand - Kristiansand, Norway
- Innlandet Hospital Trust Lillehammer - Lillehammer, Norway
- Oslo University Hospital - Oslo, Norway
- Telemark Hospital Trust Skien - Skien, Norway
- St. Olav University Hospital - Trondheim, Norway