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Clinical trial Recruiting at 2 sites Interventional Ages 18 to 65

New methods to test preventive migraine treatment

Official title: New Methods for Evaluating Preventive Migraine Treatment

Run by University of Aarhus · NCT07071506 · Data updated 2026-11-12

This trial will test how the active medicine, placebo injections, and the information given about them affect symptoms in adults with chronic migraine.

Quick facts

Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment60 (estimated)
SponsorUniversity of Aarhus
Academic / other
Drugs / interventionsfemanezumab, fremanezumab
Locations2 sites (Aarhus C, Denmark and 1 other locations)
StatusRecruiting
StartedJune 19, 2025
Main results expectedSeptember 2028
Study endsSeptember 2028
Registry record updatedMay 19, 2026
Trial IDNCT07071506 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–65 with chronic migraine diagnosed by ICHD-3, who are eligible for preventive treatment and can read and speak Danish, are the ideal candidates.

Probably not a fit

Patients who recently received onabotulinumtoxinA, use unstable preventive medications, opioids, or have had recent device/nerve-block preventive treatments are excluded and unlikely to benefit from participating.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This within-subject, balanced placebo design enrolls adults with chronic migraine who will receive four subcutaneous injections over eight months in a randomized order: two fremanezumab and two placebo injections. Neither patients nor investigators know which injection is given, but the information provided to patients about what they receive will be varied to separate pharmacologic effects from expectation effects. Participants will record headache outcomes daily in an electronic diary for 28 days before and after each injection, with injections spaced two months apart to reduce carry-over. The trial aims to quantify interactions between drug effects, placebo responses, and adverse event reporting.

Why it matters

Potential benefit: If successful, the approach could lead to clearer estimates of how much preventive migraine medicines versus patient expectations reduce headaches, improving future treatment choices and trial designs.

How similar studies have gone: Prior expectation-manipulation and balanced placebo research in pain shows that patient expectations can alter outcomes, but using this design for preventive migraine injections is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Adults (18-65 years)
2. ≥ 1-year history of migraine with or without aura according to the International Classification of Headache Disorders (ICHD-3) diagnostic criteria
3. 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
4. Eligibility for preventive migraine treatment
5. Ability to speak and read Danish

Exclusion Criteria:

1. Use of onabotulinumtoxinA as preventive migraine treatment during the 4 months before inclusion
2. 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
3. Use of opioid or barbiturate medications in the last four weeks before inclusion
4. Secondary headache disorders including medication overuse headache
5. Severe psychiatric, vascular disease, or known liver disease
6. Alcohol abuse or substance abuse
7. Current or planned pregnancy and lactation

Where it's running

  • Department of Psychology and Behavioral sciences, Aarhus BSS, Aarhus University
    Aarhus C, Denmark, Denmark     Recruiting
  • Department of Neurology, Aarhus University Hospital
    Aarhus N, Denmark, Denmark     Recruiting

Study contacts

  • Principal investigator: Lene Vase, MSc, PhD, DMSc — Dept. of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark
  • Study coordinator: Sigrid Juhl Lunde, MSc, PhD
  • Email: lunde@psy.au.dk
  • Phone: 4587165956

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
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Migraine 167Migraine, With or Without Aura 2Headache Disorders 14Chronic Migraine Headache 13University of Aarhus 153
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.