Switching monoclonal antibodies for migraine treatment
Anti-Calcitonin Gene-Related Peptide (CGRP) Monoclonal Antibody Response After Switching in the Treatment of Migraine
This study is testing if switching to a different migraine medication can help people who didn't get better with their first treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Clínico Universitario de Valladolid Academic / other |
| Locations | 1 site (Valladolid) |
| Trial ID | NCT05785988 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effectiveness and tolerability of switching between different monoclonal antibodies targeting calcitonin gene-related peptide (mAb-CGRP) in patients with migraine who did not respond to their initial treatment. It aims to gather real-world evidence on how patients fare when they switch to a different mAb-CGRP after failing the first one. The study will analyze data from patients treated in a clinical setting, focusing on both effectiveness and safety endpoints as per established guidelines.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a confirmed diagnosis of migraine who have previously been treated with a mAb-CGRP.
Not a fit: Patients with other painful disorders that may interfere with the evaluation of outcomes will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into alternative treatment options for migraine patients who do not respond to their initial monoclonal antibody therapy.
How similar studies have performed: Preliminary evidence suggests that switching between mAb-CGRP therapies may be beneficial, indicating that this approach has potential based on prior findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1. Age over 18 years old; * 2. Confirmed diagnosis of migraine, according to the International Classification of Headche Disorders, 3rd version; * 3. Treatment with a mAb-CGRP as per responsible physician criteria in routine clinical practice. Exclusion Criteria: * 1. Unavailability of information prior to the treatment use; * 2. Other painful disorders that may interfere in the evaluation of the outcomes.
Where this trial is running
Valladolid
- Hospital Clínico Universitario de Valladolid — Valladolid, Spain (Recruiting)
Study contacts
- Principal investigator: David García Azorín, MD, PhD — Research coordinator
- Study coordinator: David García-Azorín, MD, MSci
- Email: davilink@hotmail.com
- Phone: +034 665 872228
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.