Trial Designs for Evaluating Migraine Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Aarhus
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Active drug for acute migraine treatment
- Placebo Oral Tablet
Treatment groups
128 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov