Molecular Phenotyping of Migraine Patients According to Sex and Age Through CGRP Quantification

Recruiting

• Conditions: Headache (Migraine); Migraine; Migraine Headache; Migraine with Aura; Migraine Without Aura; Episodic Migraine; Chronic Migraine Headache; Chronic Migraine, Headache; Episodic Migraine Headache

• Registration Number: NCT06674772
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

Patients will be asked to visit the study center 2 times, the first time for clinical assessment and a second time for sample collection. Healthy controls will only be asked to visit the study center for sample collection. A sample of blood and saliva will be collected in order to measure CGRP levels and DNA and hormone testing.

Detailed Description

CGRP is a neuropeptide related to migraine pathophysiology, which can be found in human saliva in both patients and healthy controls. The differences in CGRP levels may help us explain the differences in the treatment response.

A sample of saliva will be collected in order to measure CGRP levels and a blood sample will be collected in order to conduct a DNA test and hormones test.

Study Timeline

• Study Start: 2022-11-29
• Study First Submitted: 2024-10-24
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-03
• Study First Posted: 2024-11-05
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13
• Primary Completion: 2025-04-30
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

• Migraine patients according to ICHD-3 criteria
• Healthy controls paired to patient age and sex, without headache and without first degree family history of headache.

Exclusion Criteria

• Presence of any major medical or neurological illness.
• Presence of any salivary gland malfunction.
• Abuse or dependence to tobacco, alcohol or any drug in the previous 12 months before the enrollment.
• Active migraine preventive treatment.
• Pregnant or breastfeeding female.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CGRP level	Through study completion, an average of 1 year	Measure of CGRP in saliva
Hormone levels	Through study completion, an average of 1 year	Blood test to quantify female hormones (FSH, LH, estradiol, progesterone, prolactin) and male hormones (testosterone) in all participants except for prepubertal children.
DNA test	Through study completion, an average of 1 year	DNA testing for CGRP or its receptor related genes (CALCA, CALCB, CALCRL and RAMP1)

Trial Locations

Locations (1)

Vall d'Hebron University Hospital; 🇪🇸 Barcelona, Spain