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โ† Trials
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Trial Designs for Evaluating Migraine Treatment

RecruitingNAAges 18 Years - 65 YearsAllUniversity of Aarhus
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In plain words

What the trial is, and whether it could suit you

The study aims to test interactions between drug and placebo-responses in acute migraine treatment and to assess variation in adverse events according to treatment information provided. Using a clinical within-subjects, advanced balanced placebo design, patients with episodic migraine will receive six treatment conditions in a randomized order.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Adults (18-65 years) 2. โ‰ฅ 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 (โ‰ฅ 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 inclusion 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
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What it tests

  • Active drug for acute migraine treatment
  • Placebo Oral Tablet
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Where

2 sites
Dept. of Psychology and Behavioural Sciences
Aarhus C, Denmark
Department of Neurology, Aarhus University Hospital
Aarhus N, Denmark
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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