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NCT06692088Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 18 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
216 (estimated)
First submitted
14 Nov 2024
Start date
1 Mar 2025
Primary completion date
1 Jul 2026
Lead sponsor
Fundación Marques de Valdecilla
Diseases
Migraine
NCT number
NCT06692088

What you commit to

  • Study type: Observational
  • Planned participants: 216
  • From 1 Mar 2025 to the primary completion date, 1 Jul 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • Younger than 18 years old

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.