Status:
RECRUITING
Monoclonal Antibody Duration of REsponse in MIgraine After Treatment Interruption
Lead Sponsor:
Hospital Clínico Universitario de Valladolid
Conditions:
Migraine
Headache, Migraine
Eligibility:
All Genders
18-65 years
Brief 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 (C...
Detailed Description
Introduction: The development of new preventive treatments represents a new era in the treatment of migraine. Different drugs have shown a reduction in the number of headache days, average intensity ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 15 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05232942
Start Date
February 15 2022
End Date
August 15 2024
Last Update
April 29 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Clínico Universitario de Valladolid
Valladolid, Spain, 47010