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NCT06692088

"Longitudinal Analysis of Amylin Levels in Migraine Patients Undergoing an Anti- CGRP/CGRPr Treatment"

Not yet recruiting Last updated 18 November 2024
What this trial tests

trial in High Frequency Episodic Migraine and Chronic Migraine in 216 participants. Not yet recruiting.

Timeline
1 March 2025
Primary endpoint
1 July 2026
31 December 2026

Quick facts

Lead sponsorFundación Marques de Valdecilla
StatusNot yet recruiting
Study typeOBSERVATIONAL
Enrollment216
Start date1 March 2025
Primary completion1 July 2026
Estimated completion31 December 2026

Conditions studied

Sponsor

Fundación Marques de Valdecilla

Who can join

18 and older, any sex, with High Frequency Episodic Migraine and Chronic Migraine. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Migraine, a complex and multifaceted disorder, remains only partially understood, with therapeutic strategies often limited by individual variability in response. While targeting calcitonin gene-related peptide (CGRP) has transformed migraine management, approximately half of patients with therapies targeting the CGRP pathway experience insufficient relief, suggesting other molecular players in migraine pathophysiology may be overlooked. Emerging evidence highlights amylin, a peptide of the calcitonin family, as a promising candidate with potential mechanistic overlap with CGRP. Canonical receptor of amylin is known to interact with CGRP, and both peptides are expressed in structures relevant to migraine. Preliminary clinical findings suggest that amylin might be involved in migraine pathophysiology by developing attacks and contributing to chronification of the condition; however, its exact impact and clinical relevance remain unverified. This prospective, monocentric, cross-sectional pilot study aims to deepen our understanding of the role of amylin in chronic migraine and anti-CGRP treatment outcomes. Specifically, we will (1) measure baseline interictal serum amylin levels in chronic migraine patients receiving anti-CGRP or CGRP receptor monoclonal antibody (mAb) therapy and a group of controls matched by sex and age, (2) monitor changes in amylin levels after six months of treatment, and (3) assess the correlation between amylin levels and clinical outcomes. We hypothesize that baseline amylin levels will be elevated in migraine patients and will normalize following effective treatment, aligning with improved clinical outcomes. Conversely, persistently elevated amylin levels may correlate with poorer response rates, potentially explaining the variability of treatment outcome found in the migraine population.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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