Trial Designs for Evaluating Migraine Treatment

Launched by UNIVERSITY OF AARHUS · Sep 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how different treatments for migraines work, particularly focusing on the effects of psychological and contextual factors during treatment. Participants will be adults aged 18 to 65 who have been diagnosed with episodic migraines, which means they experience migraine headaches on 2 to 8 days a month, and have a history of using certain migraine medications. The trial is looking for volunteers who can read and speak Danish and do not have chronic migraines or other serious health issues.

If you decide to participate, you will receive six different treatment options in a random order to see how well they work for you. This study is currently recruiting participants, so if you qualify, you could contribute to important research on migraine treatments. It's a chance to help medical professionals understand more about how to effectively manage migraines and improve the quality of life for people affected by this condition.

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 episodic migraine (≥ 1 and \< 15 headache days with features of migraine on at least 2-8 days per month for \> 3 months) with and without aura and diagnosed before age 50
• • 4. Previous or active use of triptans as acute treatment for migraine
• • 5. Ability to speak and read Danish
• Exclusion Criteria:
• • 1. Chronic migraine or history of chronic migraine in the last 12 months
• • 2. Other concomitant primary headache types except for infrequent tension-type headache
• • 3. Secondary headache disorders including medication overuse headache
• • 4. Severe psychiatric, vascular or liver diseases
• • 5. Opioid or barbiturate use in the month preceding screening
• • 6. Current use of preventive migraine treatment (i.e., onabotulinum toxin A, and/or Calcitonin gene-related peptide (CGRP) monoclonal antibodies) (however, stable medical treatment with other migraine prophylactic agents is permitted, e.g. antidepressant, calcium channel blockers, beta blockers and antiepileptic drugs, 4 weeks prior to baseline until the completion of participation in the study)
• • 7. Contraindications or inability to tolerate triptans
• • 8. Current substance use disorder
• • 9. Implanted metallic or electronic device in the head
• • 10. Cardiac pacemaker or implanted or wearable defibrillator
• • 11. Use of illegal psychotropic drugs less than a week before participation in the study; regarding cannabis: less than four weeks before participation in the study
• • 12. Current pregnancy or planned pregnancy (confirmed by pregnancy test and by use of safe contraception as defined by the Danish Medicines Agency) and lactation