ClinicalTrialsFinder
RecruitingNot ApplicableNCT06617832

Trial Designs for Evaluating Migraine Treatment

Sponsor

University of Aarhus

Enrollment

128 participants

Start Date

Nov 13, 2024

Study Type

INTERVENTIONAL

Summary

The study aims to estimate treatment effects in randomized controlled trials (RCT) and a balanced placebo design (BPD) to specify how contextual and psychological factors interact in acute migraine treatment and influence adverse event occurrence. Using a clinical within-subjects design, patients with episodic migraine will receive six treatment conditions in a randomized order.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • 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 Criteria12

  • 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 baseline 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGActive drug for acute migraine treatment

Standard dose of Sumatriptan 100 mg, which is used as an acute treatment for episodic migraine

DRUGPlacebo Oral Tablet

Inactive placebo pill (100 mg) looking like the active drug

Locations(2)

Dept. of Psychology and Behavioural Sciences

Aarhus C, Denmark

Department of Clinical Medicine, Aarhus University Hospital

Aarhus N, Denmark

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06617832