NCT06459648

Study for Prevent Chronification Migraine Through Prediction of Response to Treatment With Anti-CGRP Antibodies

Prediction Study or Response to Treatment With Anti-CGRP Monoclonal Antibodies in Migraine

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 350 (estimated)
• Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study consists of an initial visit coinciding with the start of treatment, a subsequent visit after 6 months of treatment and finally another after 12 months, coinciding with the end of treatment. In case of worsening after suspension, a clinical visit will be carried out at the time of worsening to evaluate the reintroduction of the drug and in case of reintroduction, a visit will be carried out after 3 months. If patients do not worsen, a visit will be made 6 months after completing treatment. At each visit, demographic and clinical variables will be collected. In addition, 3 blood tests will be performed corresponding to the beginning of treatment, after 6 months and a month and a half from the last infiltration. Likewise, a brain MRI will be obtained prior to the start of treatment. These blood samples and neuroimaging data will be processed for subsequent analysis.

Conditions

• Migraine

Interventions

Type	Name	Description
OTHER	Headache record	The patient will keep a record of the presence/absence of headache, average intensity, and need for acute medication.
OTHER	Scales	Each patient performs different scales that measure the impact of the migraine on their daily life as well as the disability it may be causing. In turn, each patient performs different scales that measure associated comorbidities such as depression, anxiety or insomnia.
DRUG	Monoclonal antibody anti-CGRP	Erenumab, Galcenazumeb, Fremanezumab, Eptinezumab

Timeline

• Start date: 2023-04-26
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-06-14
• Last updated: 2025-09-24

Locations

7 sites across 1 country: Spain

Regulatory

• FDA-regulated drug study