Clinical trial NCT06459648: Study for Prevent Chronification Migraine Through Prediction of Response to Treatment With Anti-CGRP Antibodies
Official title: Prediction Study or Response to Treatment With Anti-CGRP Monoclonal Antibodies in Migraine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Migraine
Keywords: Migraine
headache
antibodies
antibody
monoclonal antibody
anti-cgrp
anti cgrp
cgrp
prediction
treatmen
migraine treatment
treatment with anti-CGRP monoclonal antibodies
anti-cgrp antibodies
anti-cgrp antibody
anti-cgrp monoclonal antibodies
migraine and antibodies
migraine and cgrp
Lead sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged between 18 and 65 years with a diagnosis of episodic or chronic migraine who, at the discretion of their neurologist and according to clinical practice guidelines and standard of care, receive treatment with monoclonal antibodies against CGRP (Galcanezumab, Fremanezumab, Eptinezumab) or its receptor (Erenumab) be included. These patients will come from 7 Headache Units in Spain belonging to the following hospitals:

* La Princesa University Hospital
* Vall d'Hebron University Hospital
* Marqués de Valdecilla University Hospital
* Valladolid University Clinical Hospital
* Donostia University Hospital
* Lozano Blesa University Clinical Hospital
* La Fe Polytechnic University Hospital

Brief 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.

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.

Primary outcomes:
measure: Biomarkers of positive initial response to monoclonal antibodies
timeFrame: From the beginning of treatment, which is the initial visit, to 18 months of follow-up
Secondary outcomes:
measure: Sustained response factors
timeFrame: From the beginning of treatment, which is the initial visit, to 18 months of follow-up
measure: Sustained response after discontinuation of the anti-CGRP antibody
timeFrame: From the beginning of treatment, which is the initial visit, to 18 months of follow-up
measure: Non-maintained pharmacological response relation with biomarkers
timeFrame: From the beginning of treatment, which is the initial visit, to 18 months of follow-up
measure: Time until relapse after discontinuation of the anti-CGRP antibody
timeFrame: From the beginning of treatment, which is the initial visit, to 18 months of follow-up
measure: Biomarkers of patients with high-frequency episodic migraine and chronic migraine
timeFrame: From the beginning of treatment, which is the initial visit, to 18 months of follow-up
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
state: Aragón
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
state: Castilla Y León
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron Research Institute
state: Cataluña
city: Valencia
country: Spain
facility: Hospital Universitario Politécnico La Fe
state: Comunidad Valenciana
city: Donostia
country: Spain
facility: Hospital Universitario Donostia
state: País Vasco
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
Study officials:
affiliation: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Ana Beatriz Gago Veiga
role: PRINCIPAL_INVESTIGATOR
References: