Trial Designs for Evaluating Migraine Treatment
Recruiting · NCT06617832 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Aarhus
View the official record on ClinicalTrials.gov →Interventions studied
Active drug for acute migraine treatmentPlacebo Oral Tablet
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Adults (18-65 years)
- ≥ 1-year history of migraine with or without aura according to the International Classification of Headache Disorders (ICHD-3) diagnostic criteria
- 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
- Previous or active use of triptans as acute treatment for migraine
- Ability to speak and read Danish
Exclusion criteria
- Chronic migraine or history of chronic migraine in the last 12 months
- Other concomitant primary headache types except for infrequent tension-type headache
- Secondary headache disorders including medication overuse headache
- Severe psychiatric, vascular or liver diseases
- Opioid or barbiturate use in the month preceding screening
- 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)
- Contraindications or inability to tolerate triptans
- Current substance use disorder
- Implanted metallic or electronic device in the head
- Cardiac pacemaker or implanted or wearable defibrillator
- 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
- 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 is running
2 locations listed.
- Dept. of Psychology and Behavioural Sciences - Aarhus C, Denmark
- Department of Neurology, Aarhus University Hospital - Aarhus N, Denmark