NCT06633484Active, not recruiting
BIOMIGA: Results From Magnetic Resonance Imaging
BIOmarkers of MIGraine: a Proof of Concept Study on the Stratification of Responders to CGRP Monoclonal Antibodies - Results From Magnetic Resonance Imaging
Source: ClinicalTrials.gov · Last updated 19 May 2026
Brief summary (registry, in English)
The projects comprising in the multicenter BIOMIGA project have been preregistered earlier with ID NTC04503083 at clinicaltrials.gov. Here the imaging subproject within the overall BIOMIGA aims is specified. The hypotheses for this subproject of the magnetic resonance imaging part is based on hypotheses generating analyses of the data from one site (Hamburg, Germany) of this three-center study. At all three sites healthy controls and migraine patients underwent identical protocols with 3 types of magnetic resonance imaging including structural scans (MPRAGE), resting-state functional magnetic resonance imaging (rs-fMRI) as well as arterial spin labeling (ASL) with matched protocols across sites. Data was acquired before CGRP-antibody administration (day 1) and 12 weeks afterwards (day 2). We analyzed the data from one site (Hamburg, Germany) as hypotheses generating, published these data as a poster and aim to validate our results with the not-yet analyzed data from the two other sites (Pavia, Italy and Barcelona, Spain).
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 219 (estimated)
- First submitted
- 30 Jul 2024
- Start date
- 15 Jan 2021
- Primary completion date
- 1 Mar 2025
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Diseases
- Migraine
- NCT number
- NCT06633484
What you commit to
- Study type: Observational
- Planned participants: 219
- From 15 Jan 2021 to the primary completion date, 1 Mar 2025
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Medication overuse according to the ICHD-3 criteria.
- For the entire study population (migraine and healthy controls)
- Evidence of drug, smoking or alcohol abuse or dependence within 12 months prior to V1, based on medical records or patient self-report. An alcohol consumption \>100g/week will be considered as an abuse;
- Concomitant use of other migraine preventive drugs that may interfere with the endpoints of the study.
Other illness
- Presence of any other significant medical condition (neurological disorders, severe psychiatric illness or cardiovascular disease);
Other
- For the clinical population:
- Headache on more than 25 days/month in the last 3 months;
- Pregnant or breastfeeding women;
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant who are not on contraception;
Who the study is looking for
- Migraine patients
- Adults between 25 and 55 years of age of both sexes;
- Patients diagnosed with high-frequency migraine (HFM) 8 or more migraine days/month) or CM with or without aura (\>15 headache days migraine/month, of which 8 have migraine characteristics) according to the International Classification of Headache Disorders, 3rd edition, (ICHD-3);
- Females had to be postmenopausal for at least one year, surgically sterile or otherwise incapable of pregnancy, or using an acceptable method of birth control.
- Healthy controls
- Adults between 25 and 55 years of age of both sex;
- Absence of any past, or first-degree familial history of recurrent primary or secondary headache disorders.
Age in the registry: 25 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Vall d'Hebron Institute of Research Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| IRCCS Mondino Foundation Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.