New methods to test preventive migraine treatment
New Methods for Evaluating Preventive Migraine Treatment
NA · University of Aarhus · NCT07071506
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Aarhus (other) |
| Drugs / interventions | femanezumab, fremanezumab |
| Locations | 2 sites (Aarhus C, Denmark and 1 other locations) |
| Trial ID | NCT07071506 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Aarhus C, Denmark and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Migraine, Migraine With or Without Aura, Headache Disorders, Chronic Migraine, Headache, Headache, Chronic migraine, Balanced placebo design, Treatment effects