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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Headache record
  The patient will keep a record of the presence/absence of headache, average intensity, and need for acute medication.
• Другое 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.
• Препарат Monoclonal antibody anti-CGRP
  Erenumab, Galcenazumeb, Fremanezumab, Eptinezumab

Первичные конечные точки

• Biomarkers of positive initial response to monoclonal antibodies [Срок оценки: From the beginning of treatment, which is the initial visit, to 18 months of follow-up]

Вторичные конечные точки (5)

• Sustained response factors [Срок оценки: From the beginning of treatment, which is the initial visit, to 18 months of follow-up]
• Sustained response after discontinuation of the anti-CGRP antibody [Срок оценки: From the beginning of treatment, which is the initial visit, to 18 months of follow-up]
• Non-maintained pharmacological response relation with biomarkers [Срок оценки: From the beginning of treatment, which is the initial visit, to 18 months of follow-up]
• Time until relapse after discontinuation of the anti-CGRP antibody [Срок оценки: From the beginning of treatment, which is the initial visit, to 18 months of follow-up]
• Biomarkers of patients with high-frequency episodic migraine and chronic migraine [Срок оценки: From the beginning of treatment, which is the initial visit, to 18 months of follow-up]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 7 центров

• Hospital Clínico Universitario Lozano Blesa — Zaragoza
• Hospital Universitario Donostia — Donostia / San Sebastian
• Hospital Universitario Marqués de Valdecilla — Santander
• Hospital Clínico Universitario de Valladolid — Valladolid
• Hospital Universitari Vall d'Hebron Research Institute — Barcelona
• Hospital Universitario de La Princesa — Madrid
• Hospital Universitario Politécnico La Fe — Valencia

Идентификаторы

NCT: NCT06459648 · PI 23- 3054

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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