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NCT Number: NCT06459648

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

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínico Universitario Lozano Blesa, Zaragoza, Aragon, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Headache record

Other

The patient will keep a record of the presence/absence of headache, average intensity, and need for acute medication.

Scales

Other

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.

Monoclonal antibody anti-CGRP

Drug

Erenumab, Galcenazumeb, Fremanezumab, Eptinezumab

Primary outcomes

  1. 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

    Establish clinical, demographic, transcriptomic, genetic, molecular and/or radiological characteristics that allow predicting a positive initial response to monoclonal antibodies (biomarkers of therapeutic response).

Secondary outcomes

  1. Sustained response factors

    Time frame: From the beginning of treatment, which is the initial visit, to 18 months of follow-up

    To analyze sustained response factors at the sociodemographic, clinical, transcriptomic, genetic, molecular and/or radiological level after the suspension of anti-CGRP drugs.

  2. 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

    To quantify the proportion of patients who present a sustained response after discontinuation of the anti-CGRP antibody.

  3. 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

    To characterize whether the non-maintained pharmacological response is related to the variables previously characterized as predictors of chronicity.

  4. 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

    To determine the time until relapse after discontinuation of the anti-CGRP monoclonal antibody in those patients who, having presented a positive initial response, discontinue it.

  5. 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

    To validate possible transcriptomic, genetic, molecular and/or radiological characteristics that allow differentiation between patients with high-frequency episodic migraine and chronic migraine in a national multicenter cohort.

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Beatriz Gago Veiga

CONTACT

[email protected]

+34 915202416

Iris Fernández Lázaro

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Other

Registry information

Official study title

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

Acronym: PREDI-CGRP

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 14, 2024
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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