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

Recruiting
18 - 65 years of age
Both
Phase N/A

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Overview

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.

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.

Eligibility

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.

Study details

Migraine

NCT06459648

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

24 June 2024

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