Evaluating migraine treatment effects using different designs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to estimate treatment effects for acute migraine using a randomized controlled trial (RCT) and a balanced placebo design (BPD). It investigates how contextual and psychological factors, such as treatment expectations, influence the effectiveness of migraine treatments. Patients with episodic migraine will undergo six treatment conditions in a randomized order, receiving either an active drug (sumatriptan) or a placebo, while being informed differently about their treatment. The goal is to determine if the drug effect varies between the RCT and BPD approaches, and how active drug responses interact with placebo responses.

Why it matters

Who can join: the full rules

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 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

Where it's running

• Department of Neurology, Aarhus University Hospital
  Aarhus N, Denmark Recruiting
• Dept. of Psychology and Behavioural Sciences
  Aarhus C, Denmark Not yet recruiting

Study contacts

• Study coordinator: Sigrid Juhl Lunde, MSc, PhD
• Email: lunde@psy.au.dk
• Phone: 4587165956

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Evaluating the effectiveness of rimegepant for treating migraines

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• MySalvia System for Resistant Migraine: a minimally invasive implant to prevent migraines

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.