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

Migraine Clinical Trial

— PREDI-CGRP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06459648
• Other study ID #: PI 23- 3054
• Status: Recruiting
• Start date: April 26, 2023
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
• Contact: Ana Beatriz Gago Veiga
• Phone: +34 915202416
• Email: anabeatriz.gago[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron Research Institute	Barcelona	Cataluña
Spain	Hospital Universitario Donostia	Donostia	País Vasco
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital Universitario Politécnico La Fe	Valencia	Comunidad Valenciana
Spain	Hospital Clínico Universitario de Valladolid	Valladolid	Castilla Y León
Spain	Hospital Clínico Universitario Lozano Blesa	Zaragoza	Aragón

Sponsors (1)

Lead Sponsor	Collaborator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers of positive initial response to monoclonal antibodies	Establish clinical, demographic, transcriptomic, genetic, molecular and/or radiological characteristics that allow predicting a positive initial response to monoclonal antibodies (biomarkers of therapeutic response).	From the beginning of treatment, which is the initial visit, to 18 months of follow-up
Secondary	Sustained response factors	To analyze sustained response factors at the sociodemographic, clinical, transcriptomic, genetic, molecular and/or radiological level after the suspension of anti-CGRP drugs.	From the beginning of treatment, which is the initial visit, to 18 months of follow-up
Secondary	Sustained response after discontinuation of the anti-CGRP antibody	To quantify the proportion of patients who present a sustained response after discontinuation of the anti-CGRP antibody.	From the beginning of treatment, which is the initial visit, to 18 months of follow-up
Secondary	Non-maintained pharmacological response relation with biomarkers	To characterize whether the non-maintained pharmacological response is related to the variables previously characterized as predictors of chronicity.	From the beginning of treatment, which is the initial visit, to 18 months of follow-up
Secondary	Time until relapse after discontinuation of the anti-CGRP antibody	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.	From the beginning of treatment, which is the initial visit, to 18 months of follow-up
Secondary	Biomarkers of patients with high-frequency episodic migraine and chronic migraine	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.	From the beginning of treatment, which is the initial visit, to 18 months of follow-up