Evaluating how long migraine relief lasts after stopping monoclonal antibody treatment
Monoclonal Antibody Duration of REsponse in MIgraine After Treatment Interruption: A Prospective National Study
This study is testing how long people with migraines can stay pain-free after stopping a specific treatment and what factors might affect that time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hospital Clínico Universitario de Valladolid Academic / other |
| Drugs / interventions | erenumab, galcanezumab, fremanezumab, eptinezumab |
| Locations | 1 site (Valladolid) |
| Trial ID | NCT05232942 on ClinicalTrials.gov |
What this trial studies
This observational study analyzes the duration of response in patients with episodic and chronic migraines who have previously responded to monoclonal antibodies targeting CGRP or its receptor. Participants will maintain a headache diary to track their symptoms after discontinuing treatment. The primary goal is to determine the time it takes for patients to revert to their pre-treatment migraine status. Additionally, the study will explore factors that may influence the sustainability of treatment benefits.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with episodic or chronic migraines who have previously responded positively to monoclonal antibody treatments.
Not a fit: Patients with other chronic headache disorders or those who have not responded to monoclonal antibody treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness of monoclonal antibody treatments for migraine, guiding future treatment decisions.
How similar studies have performed: While there have been studies on the effectiveness of monoclonal antibodies for migraine, this specific focus on the duration of response after treatment interruption is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Valladolid
- Hospital Clínico Universitario de Valladolid — Valladolid, Spain (Recruiting)
Study contacts
- Principal investigator: David García Azorín, MD, PhD — Research coordinator
- Study coordinator: David Garcia Azorin, MD, PhD
- Email: davilink@hotmail.com
- Phone: +34 665872228
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.