Migraine Clinical Trial
— MADRE-MIAOfficial title:
Monoclonal Antibody Duration of REsponse in MIgraine After Treatment Interruption: A Prospective National Study
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | August 15, 2024 |
Est. primary completion date | February 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Patients diagnosed with episodic or chronic migraine according to criteria of the International Classification of Headache Disorders, 3rd Edition. 2. 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. 3. Patients who experienced a positive therapeutic response to mAbs. 4. Patients that received the treatment for a minimum of 3 months. 5. Age between 18 and 65 years. 6. Participants must be capable to describe his/her clinical situation and the characteristics of his/her headache. 7. Participants must have signed the informed consent and have sufficient understanding of Spanish language. Exclusion Criteria: 1. 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. 2. 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. 3. 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. 4. Pregnancy or breastfeeding. 5. Patients who discontinued treatment with the monoclonal antibody due to an adverse effect and not to an efficacy response. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clínico Universitario de Valladolid | Valladolid |
Lead Sponsor | Collaborator |
---|---|
Hospital Clínico Universitario de Valladolid |
Spain,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Return to the baseline | The needed number of months elapsed until the patient has a number of headache days per month that equals the situation at the moment of the monoclonal antibody onset, or the need of other prophylactic medication. | Through study completion, an average of 3 months | |
Secondary | Worsening within the first three months | Determine the percentage of patients who have returned to their previous situation, or require preventive treatment once again between 15 and 90 days (3 months). | Through study completion, an average of 3 months | |
Secondary | Worsening between three and six months | Determine the percentage of patients who have returned to their previous situation, or require preventive treatment once again between 91 and 180 days (6 months). | Through study completion, an average of 6 months | |
Secondary | Worsening between six and nine months | Determine the percentage of patients who have returned to their previous situation, or require preventive treatment once again between 181 and 270 days (9 months). | Through study completion, an average of 9 months | |
Secondary | Worsening between nine and twelve months | Determine the percentage of patients who have returned to their previous situation, or require preventive treatment once again between 271 and 365 days (12 months). | Through study completion, an average of 12 months | |
Secondary | Explore predictors of a more prolonged response | Determine which demographic and clinical variables are associated with a more prolonged benefit over time. | Through study completion, an average of 12 months |
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