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NCT06459648 | RECRUITING | Migraine

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

Biomedical Research Foundation - La Princesa 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.

Condition or disease

Migraine

Intervention/treatment

Headache record

Scales

Monoclonal antibody anti-CGRP

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 350 participants
Official Title : Prediction Study or Response to Treatment With Anti-CGRP Monoclonal Antibodies in Migraine
Actual Study Start Date : 2023-04-26
Estimated Primary Completion Date : 2025-06
Estimated Study Completion Date : 2025-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Study for Prevent Chronification Migraine Through Prediction of Response to Treatment With Anti-CGRP Antibodies

Location Details

NCT06459648

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Spain, Aragon

Lozano Blesa University Clinical Hospital

Zaragoza, Aragon, Spain, 50009

RECRUITING

Spain, Cantabria

Marqués de Valdecilla University Hospital

Santander, Cantabria, Spain, 39008

RECRUITING

Spain, Castile and Leon

University Clinical Hospital of Valladolid

Valladolid, Castilla y León, Spain, 47010

RECRUITING

Spain, Catalonia

Vall d'Hebron University Hospital Research Institute

Barcelona, Catalonia, Spain, 08035

RECRUITING

Spain, Valencian Community

La Fe Polytechnic University Hospital

Valencia, Valencian Community, Spain, 46026

RECRUITING

Spain, the Basque Country

Donostia University Hospital

Donostia, The Basque Country, Spain, 20014

RECRUITING

Spain,

La Princesa University Hospital

Madrid, Spain, 28006