New Methods for Evaluating Preventive Migraine Treatment

Launched by UNIVERSITY OF AARHUS · Jul 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying new ways to understand how preventive treatments work for people with chronic migraine, a condition where headaches happen very often—at least 15 days a month for more than three months. The researchers want to see how different factors, including the treatment itself and the context around it, affect both how well the treatment works and if it causes any side effects. To do this, participants will go through four different treatment scenarios in a random order, allowing the study team to compare results within the same person.

Adults between 18 and 65 years old who have had migraines for at least a year and have been diagnosed with chronic migraine before age 50 may be eligible to join. Participants need to be able to speak and read Danish and qualify for preventive migraine treatment after evaluation by a neurologist. People currently using certain migraine treatments like Botox or opioids, or those with other serious health issues, are not eligible. If you join, you can expect to receive different treatment conditions during the study, which will help doctors better understand how preventive migraine treatments work and how side effects might happen. This research could lead to improved ways to prevent migraines in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults (18-65 years)
• • 2. ≥ 1-year history of migraine with or without aura according to the International Classification of Headache Disorders (ICHD-3) diagnostic criteria
• • 3. Known chronic migraine (headache occurring ≥ 15 days per month for \> 3 months, which on at least 8 days per month has the features of migraine headache) diagnosed before age 50
• • 4. Qualifying for preventive migraine treatment (screened by neurologist)
• • 5. Ability to speak and read Danish
• Exclusion Criteria:
• • 1. Use of onabotulinumtoxinA as preventive migraine treatment during the 4 months before screening
• • 2. Use of other preventive migraine treatment other than CGRP antagonists (However, participants are allowed to be on one stable preventive medication (antidepressant, calcium channel blockers, beta blockers or antiepileptic)- 2 months prior to screening until end of study , if necessary), devices for migraine prevention such as transcranial magnetic stimulation and use of nerve blocks 3 months prior to screening
• • 3. Use of opioid or barbiturate medications in the last four weeks before participation in the study
• • 4. Secondary headache disorders including medication overuse headache
• • 5. Severe psychiatric, vascular disease, or known liver disease
• • 6. Alcohol abuse, drug abuse, or substance abuse
• • 7. Current or planned pregnancy and lactation