Actively Recruiting
New Methods for Evaluating Preventive Migraine Treatment
Led by University of Aarhus · Updated on 2026-05-19
60
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how drug and placebo responses interact in treating chronic migraine and how adverse events vary depending on the treatment information given to patients. This study uses a balanced placebo design to address limitations of traditional double-blind randomized controlled trials. Patients with chronic migraine will receive four injections over eight months in a randomized order to better understand treatment effects and the role of patient expectations. Participants will receive four injections spaced two months apart after a one-month baseline period without treatment. Half of the injections are fremanezumab, an active drug, and the other half are inactive placebo injections, all appearing identical. Neither patients nor investigators know which injection is given at each visit, and information about the treatment will also be varied to assess its impact. Patients complete electronic pain and headache diaries daily for 28 days before and after each injection and fill out questionnaires on quality of life, psychological factors, and headache burden. During the trial, researchers will monitor headache intensity and frequency daily, as well as adverse events at multiple time points after each injection. Additional measures include migraine days, acute treatment use, mood and anxiety scales, and quality of life assessments. Patient adherence and blinding will be evaluated throughout. The study is expected to last eight months, with assessments and questionnaires completed regularly to track treatment effects and safety.
CONDITIONS
Brief Title
New Methods for Evaluating Preventive Migraine Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- History of migraine with or without aura for at least 1 year based on ICHD-3 criteria
- Diagnosed with chronic migraine (headaches \u2265 15 days per month for more than 3 months with migraine features on at least 8 days per month)
- Eligible for preventive migraine treatment
- Ability to speak and read Danish
You will not qualify if you...
- Use of onabotulinumtoxinA for migraine prevention within 4 months prior to inclusion
- Use of other preventive migraine treatments except CGRP antagonists, with allowance for two stable medications (antidepressants, calcium channel blockers, beta blockers, or antiepileptics) from 2 months before inclusion through study end
- Use of migraine prevention devices (e.g., transcranial magnetic stimulation) or nerve blocks within 3 months prior to inclusion
- Use of opioid or barbiturate medications within 4 weeks before inclusion
- Secondary headache disorders including medication overuse headache
- Severe psychiatric conditions, vascular disease, or known liver disease
- Alcohol or substance abuse
- Current or planned pregnancy and breastfeeding
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 month
Participants do not receive treatment during the first month but begin daily rating of headache and migraine symptoms using an electronic pain/headache diary at home.
Daily electronic diary entries at home
Duration - 8 months
Participants receive 4 injections over 8 months. Each injection is given every second month and may be either an active drug or placebo. Participants continue daily headache diary ratings and complete questionnaires assessing quality of life, psychological parameters, and headache burden before and after each injection.
4 injection visits every 2 months, daily electronic diary entries, and questionnaires pre-treatment and 28 days after each injection
Trial Site Locations
Total: 2 locations
1
Department of Psychology and Behavioral sciences, Aarhus BSS, Aarhus University
Aarhus C, Denmark, Denmark, 8000
Actively Recruiting
2
Department of Neurology, Aarhus University Hospital
Aarhus N, Denmark, Denmark, 8200
Actively Recruiting
Research Team
S
Sigrid Juhl Lunde, MSc, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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