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Compares treatment options for Migraine
Official title The Nordic Chronic Migraine Trial of CGRP Monoclonal Antibody and Onabotulinumtoxin A Dual Therapy Compared to CGRP mAbs Monotherapy
ClinicalTrials.gov ID: NCT07040813
What this study is testing
What is CGRP mAbs and onabotulinumtoxin A?
CGRP mAbs and onabotulinumtoxin A is an investigational medicine, given as an once-daily injection into a muscle, being studied as a potential treatment for migraine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 12 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- Indications for treatment with CGRP mAbs according to SmPCs.
- Indications for treatment with BTA according to SmPC.
You likely can't join if
- 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...
- 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.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Grålum, Norway
- Kristiansand, Norway
- Lillehammer, Norway
- Oslo, Norway
- Skien, Norway
- Trondheim, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grålum, Norway; Kristiansand, Norway; Lillehammer, Norway; Oslo, Norway; Skien, Norway; Trondheim, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.