Evaluating migraine treatment effects using different designs
Trial Designs for Evaluating Migraine Treatment
This study is testing how different ways of giving treatment information affect the effectiveness of a migraine medication compared to a placebo in people with episodic migraines.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 2 sites (Aarhus C and 1 other locations) |
| Trial ID | NCT06617832 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a history of episodic migraine, experiencing 2-8 headache days per month.
Not a fit: Patients with chronic migraine or other primary headache disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective migraine treatments by better understanding the role of psychological factors in treatment response.
How similar studies have performed: Previous studies have shown that alternative trial designs can yield different insights into treatment effects, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Aarhus C and 1 other locations
- Dept. of Psychology and Behavioural Sciences — Aarhus C, Denmark (Not_yet_recruiting)
- Department of Neurology, Aarhus University Hospital — Aarhus N, Denmark (Recruiting)
Study contacts
- Study coordinator: Sigrid Juhl Lunde, MSc, PhD
- Email: lunde@psy.au.dk
- Phone: 4587165956
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.