Predicting migraine treatment response with anti-CGRP antibodies
Prediction Study or Response to Treatment With Anti-CGRP Monoclonal Antibodies in Migraine
This study is trying to see if certain tests can help doctors predict how well migraine patients will respond to a new type of treatment using anti-CGRP antibodies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa Academic / other |
| Locations | 7 sites (Zaragoza, Aragon and 6 other locations) |
| Trial ID | NCT06459648 on ClinicalTrials.gov |
What this trial studies
This observational study aims to predict how patients with migraine will respond to treatment using anti-CGRP monoclonal antibodies. It involves an initial visit at the start of treatment, followed by assessments at 6 and 12 months, including blood tests and brain MRI scans. The study will analyze various clinical, biological, and neuroimaging variables to improve treatment outcomes and quality of life for migraine sufferers. The goal is to enhance the ability of clinicians to anticipate treatment responses based on individual patient data.
Who should consider this trial
Good fit: Ideal candidates are Caucasian patients aged 18 to 65 with a history of migraine, experiencing high-frequency episodic aura or chronic migraines.
Not a fit: Patients with non-migraine headaches, neurological issues, or cognitive deficiencies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for migraine patients by personalizing treatment approaches.
How similar studies have performed: Other studies have shown promise in predicting treatment responses for migraines, but this specific approach using anti-CGRP antibodies is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged between 18 and 65 years. * Caucasian ethnicity. * Patients diagnosed with migraine with and without high-frequency episodic aura (more than 8 days of migraine per month) or chronic by a neurologist expert in headaches and according to the criteria proposed in the International Classification of Headache Diseases, 3rd edition (ICHD- 3). * Have at least one year of history of migraine. * Patients must maintain stable preventive treatment in the previous month and not have received botulinum toxin in the month prior to starting the monoclonal antibody. * Patients able to describe their clinical situation and the characteristics of their headache. * Grant your informed consent. Exclusion Criteria: * Patients who present with another type of non-migraine headache, with the exception of headache due to excessive use of analgesic medication. * Neurological focus in the examination. * Pregnancy or breastfeeding period. * Patients with cognitive deficiency or pathology that may prevent or hinder the correct completion of the study. * Patients who require changes in preventive treatment during the first 6 months after starting treatment with monoclonal antibodies. * Patients who present any significant adverse effect that requires withdrawal or change of anti-CGRP drug.
Where this trial is running
Zaragoza, Aragon and 6 other locations
- Hospital Clínico Universitario Lozano Blesa — Zaragoza, Aragon, Spain (Recruiting)
- Hospital Universitario Donostia — Donostia / San Sebastian, Basque Country, Spain (Recruiting)
- Hospital Universitario Marqués de Valdecilla — Santander, Cantabria, Spain (Recruiting)
- Hospital Clínico Universitario de Valladolid — Valladolid, Castille and León, Spain (Recruiting)
- Hospital Universitari Vall d'Hebron Research Institute — Barcelona, Catalonia, Spain (Recruiting)
- Hospital Universitario de La Princesa — Madrid, Madrid, Spain (Recruiting)
- Hospital Universitario Politécnico La Fe — Valencia, Valencia, Spain (Recruiting)
Study contacts
- Principal investigator: Ana Beatriz Gago Veiga — Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Study coordinator: Ana Beatriz Gago Veiga
- Email: anabeatriz.gago@salud.madrid.org
- Phone: +34 915202416
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.