RecruitingNCT05232942

Monoclonal Antibody Duration of REsponse in MIgraine After Treatment Interruption

Monoclonal Antibody Duration of REsponse in MIgraine After Treatment Interruption: A Prospective National Study

Sponsor

Hospital Clínico Universitario de Valladolid

Enrollment

200 participants

Start Date

Feb 15, 2022

Study Type

OBSERVATIONAL

Conditions

Migraine Headache, Migraine

Summary

Observational analytic study with a prospective cohort design. Patients with episodic and chronic migraine that have responded to monoclonal antibodies (mAbs) versus calcitonin gene-related peptide (CGRP) or its receptor with positive response will be included. A headache diary will be completed in a daily basis. The primary outcome will be the time elapsed between the discontinuation of the monoclonal antibody and the return to the clinical situation at the moment of the mAbs onset. The potential variables that may be associated with a more sustained benefit will be explored.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria7

Patients diagnosed with episodic or chronic migraine according to criteria of the International Classification of Headache Disorders, 3rd Edition.
Patients who previously received treatment with a monoclonal antibody (mABs) against CGRP or its receptor at the discretion of their usual neurologist, according to the standard of care and local guidelines.
Patients who experienced a positive therapeutic response to mAbs.
Patients that received the treatment for a minimum of 3 months.
Age between 18 and 65 years.
Participants must be capable to describe his/her clinical situation and the characteristics of his/her headache.
Participants must have signed the informed consent and have sufficient understanding of Spanish language.

Exclusion Criteria5

Presence of another type of concomitant chronic headache, defined by frequency greater than 15 days per month in the previous three months, except for medication overuse headache.
Patients planning to start another treatment with a possible preventive effect according to the national clinical practice guidelines within the six following weeks after their inclusion in the present study for any therapeutic indication.
Patients who started another treatment with a possible preventive effect according to the national clinical practice guidelines within the previous six weeks of the evaluation of the inclusion in the present study.
Pregnancy or breastfeeding.
Patients who discontinued treatment with the monoclonal antibody due to an adverse effect and not to an efficacy response.

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERHeadache calendar completion

The patient will complete an in-paper or electronic calendar, depicting the presence/absence of headache, the median intensity and the need of acute medication.