Sponsor study identifier
Secondary identifiers
OTHER_GRANT · International Headache Society
observational
216
0 countries
N/A
Study Start
March 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 14, 2024
Actual (reported)November 18, 2024
Actual (reported)March 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Circulating concentrations of Amylyn
Levels of amylin across the different time points.
Up to 6 months
Evolution of Monthly Migraine Days (MMDs)
6 months
Evolution of Monthly Headache Days (MHDs)
6 months
Evolution of medication intake
6 months
Patients diagnosed with either high frecuancy episodic or chronic migraine and prescribed with anti-CGRP/CGRPr monoclonal antibodies without having started their treatment.
Subjects without history of migraine or any other primary headache.
Our study population are patients diagnosed with either High High Frequency Episodic Migraine or Chronic Migraine who fulfil the criteria set by our institution to be prescribed an anti-CGRP/CGRPr monoclonal antibody by our body of neurology specialist.
Serum samples will be obtained from blood extractions of peripheral circulation.
First Submitted
November 14, 2024
First Posted
November 18, 2024
Study Start
March 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 1, 2026
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
November 18, 2024
Record last verified: 2024-11
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