Clinical trial
Prediction Study or Response to Treatment With Anti-CGRP Monoclonal Antibodies in Migraine
Name
PI 23- 3054
Description
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.
Trial arms
Trial start
2023-04-26
Estimated PCD
2025-06-01
Trial end
2025-12-01
Status
Recruiting
Treatment
Headache record
The patient will keep a record of the presence/absence of headache, average intensity, and need for acute medication.
Arms:
Patients with migraine under treatment with monoclonal antibodies against CGRP
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.
Arms:
Patients with migraine under treatment with monoclonal antibodies against CGRP
Monoclonal antibody anti-CGRP
Erenumab, Galcenazumeb, Fremanezumab, Eptinezumab
Arms:
Patients with migraine under treatment with monoclonal antibodies against CGRP
Size
350
Primary endpoint
Biomarkers of positive initial response to monoclonal antibodies
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '18 Months', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The samples collected from the patients in the study are blood and neuroimaging samples, specifically, brain MRIs without contrast. Thanks to the blood samples, serum, plasma as well as peripheral blood mononuclear cells (PBMCs) will be analyzed. This analysis will allow measurement of CGRP levels in blood, genome sequencing to obtain the genotype of each participant and estimate their polygenic risk of disease, methylome sequencing to obtain the methylation profile of the CpG islands described in human chips and finally data of transcriptomics, specifically miRNA.'}, 'enrollmentInfo': {'count': 350, 'type': 'ESTIMATED'}}
Updated at
2024-06-14
1 organization
1 product
1 indication
Indication
Migraine