New Methods for Evaluating Preventive 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, balanced placebo design, patients with chronic migraine will receive four 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 chronic migraine (headache occurring ≥ 15 days per month for > 3 months, which on at least 8 days per month has the features of migraine headache) diagnosed before age 65
Eligibility for preventive migraine treatment
Disqualifiers
Use of onabotulinumtoxinA as preventive migraine treatment during the 4 months before inclusion
Use of other preventive migraine treatment except CGRP antagonists (However, participants are allowed to be on two stable preventive medication (antidepressant, calcium channel blockers, beta blockers or antiepileptic)- 2 months prior to inclusion until end of study), devices for migraine prevention such as transcranial magnetic stimulation and use of nerve blocks 3 months prior to inclusion
Use of opioid or barbiturate medications in the last four weeks before inclusion
Secondary headache disorders including medication overuse headache
Trial design
Treatments tested in this trial
- Active drug for chronic migraine treatment.
- Placebo Subcutaneous injection
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov