Study for Prevent Chronification Migraine Through Prediction of Response to Treatment With Anti-CGRP Antibodies
Recruiting · NCT06459648 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
View the official record on ClinicalTrials.gov →Interventions studied
Headache recordMonoclonal antibody anti-CGRPScales
What this trial is about
Being able to predict each patients response to a specific treatment can mean a significant improvement in socioeconomic costs, but above all in their quality of life. With the present study, the investigators aim to analyze in a combined way different clinical, biological and neuroimaging variables, which allow the clinical staff to anticipate the response to treatment with anti-CGRP monoclonal antibodies in patients with migraine.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
7 locations listed.
- Hospital Clínico Universitario Lozano Blesa - Zaragoza, Aragon, Spain
- Hospital Universitario Donostia - Donostia / San Sebastian, Basque Country, Spain
- Hospital Universitario Marqués de Valdecilla - Santander, Cantabria, Spain
- Hospital Clínico Universitario de Valladolid - Valladolid, Castille and León, Spain
- Hospital Universitari Vall d'Hebron Research Institute - Barcelona, Catalonia, Spain
- Hospital Universitario de La Princesa - Madrid, Madrid, Spain
- Hospital Universitario Politécnico La Fe - Valencia, Valencia, Spain