New Methods for Evaluating Preventive Migraine Treatment
Recruiting · NCT07071506 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Aarhus
View the official record on ClinicalTrials.gov →Interventions studied
Active drug for chronic migraine treatment.Placebo Subcutaneous injection
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, balanced placebo design, patients with chronic migraine will receive four 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 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
- Ability to speak and read Danish
Exclusion criteria
- 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
- Severe psychiatric, vascular disease, or known liver disease
- Alcohol abuse or substance abuse
- Current or planned pregnancy and lactation
Where it is running
2 locations listed.
- Department of Psychology and Behavioral sciences, Aarhus BSS, Aarhus University - Aarhus C, Denmark, Denmark
- Department of Neurology, Aarhus University Hospital - Aarhus N, Denmark, Denmark