"Longitudinal Analysis of Amylin Levels in Migraine Patients Undergoing an Anti- CGRP/CGRPr Treatment"
2 other identifiers
observational
216
0 countries
N/A
Brief Summary
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.
Trial Health
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participants targeted
Target at P75+ for all trials
Started Mar 2025
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2024
CompletedFirst Posted
Study publicly available on registry
November 18, 2024
CompletedStudy Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
November 18, 2024
November 1, 2024
1.3 years
November 14, 2024
November 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Circulating concentrations of Amylyn
Levels of amylin across the different time points.
Up to 6 months
Other Outcomes (3)
Evolution of Monthly Migraine Days (MMDs)
6 months
Evolution of Monthly Headache Days (MHDs)
6 months
Evolution of medication intake
6 months
Study Arms (2)
Migraine
Patients diagnosed with either high frecuancy episodic or chronic migraine and prescribed with anti-CGRP/CGRPr monoclonal antibodies without having started their treatment.
Healthy controls
Subjects without history of migraine or any other primary headache.
Eligibility Criteria
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.
You may qualify if:
- Diagnosed with either: a) High Frequency Episodic Migraine or b) Chronic Migraine
- Prescribed with anti-CGRP/CGRPr monoclonal antibodies whi have not yet started his/her treatment.
- No history or migraine or any other kind of headache.
- Daily consumption of any kind of analgesic treatment.
You may not qualify if:
- Younger than 18 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
Serum samples will be obtained from blood extractions of peripheral circulation.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph.D
Study Record Dates
First Submitted
November 14, 2024
First Posted
November 18, 2024
Study Start
March 1, 2025
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
November 18, 2024
Record last verified: 2024-11