Study for Prevent Chronification Migraine Through Prediction of Response to Treatment With Anti-CGRP Antibodies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Headache record, Scales, Monoclonal antibody anti-CGRP.
- Who it may be relevant to
- Registry conditions: Migraine. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prediction Study or Response to Treatment With Anti-CGRP Monoclonal Antibodies in Migraine
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.
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.
Interventions
- 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
Primary outcome measures
- Biomarkers of positive initial response to monoclonal antibodies [Time frame: From the beginning of treatment, which is the initial visit, to 18 months of follow-up]
Secondary outcome measures (5)
- Sustained response factors [Time frame: 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 [Time frame: From the beginning of treatment, which is the initial visit, to 18 months of follow-up]
- Non-maintained pharmacological response relation with biomarkers [Time frame: 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 [Time frame: 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 [Time frame: From the beginning of treatment, which is the initial visit, to 18 months of follow-up]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 7 centers
- 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
Identifiers
NCT: NCT06459648 · PI 23- 3054