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

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Status: Enrolling

Conditions: Migraine

Treatments: Other: Headache record; Other: Scales; Drug: Monoclonal antibody anti-CGRP

Study type: Observational

Funder types: Other

Identifiers

NCT06459648

PI 23- 3054

Details and patient eligibility

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.

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

350 participants in 1 patient group

Patients with migraine under treatment with monoclonal antibodies against CGRP

Description:

Patients with diagnosis of episodic or chronic migraine who, under the criteria of their neurologist and according to the clinical practice guidelines and standard of care, receive treatment with monoclonal antibodies against CGRP (Galcanezumab, Fremanezumab, Eptinezumab) or else its receptor (Erenumab) will be included.

Treatment:

Drug: Monoclonal antibody anti-CGRP

Other: Scales

Other: Headache record