NCT06674772

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
440

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2022

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

November 13, 2024

Status Verified

November 1, 2024

Enrollment Period

2.4 years

First QC Date

October 24, 2024

Last Update Submit

November 11, 2024

Conditions

Headache (Migraine)MigraineMigraine HeadacheMigraine with AuraMigraine Without AuraEpisodic MigraineChronic Migraine, HeadacheEpisodic Migraine Headache

Keywords

MigraineCGRPsaliva

Outcome Measures

Primary Outcomes (3)

  • CGRP level

    Measure of CGRP in saliva

    Through study completion, an average of 1 year

  • Hormone levels

    Blood test to quantify female hormones (FSH, LH, estradiol, progesterone, prolactin) and male hormones (testosterone) in all participants except for prepubertal children.

    Through study completion, an average of 1 year

  • DNA test

    DNA testing for CGRP or its receptor related genes (CALCA, CALCB, CALCRL and RAMP1)

    Through study completion, an average of 1 year

Study Arms (2)

Migraine Patients

Patients, male and female, with Episodic migraine, all ages.

Diagnostic Test: Saliva test

Control group

Male and female without migraine or headache

Diagnostic Test: Saliva test

Interventions

Saliva testDIAGNOSTIC_TEST

Sampling of CGRP in saliva and DNA blood test and sex hormones blood test.

Also known as: Blood test
Control groupMigraine Patients

Eligibility Criteria

Age6 Years - 75 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsOnly cis-gender male and female will be included in the study due to hormone testing.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Males and females otherwise healthy with episodic and chronic migraine in different age groups will be included in the study. Controls matching age and sex will be selected for the control groups.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vall d'Hebron University Hospital

Barcelona, Barcelona, 08035, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and saliva samples will be retained.

MeSH Terms

Conditions

Migraine DisordersMigraine with AuraMigraine without AuraHeadache

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

Patricia Pozo-Rosich, MD, PhD

CONTACT

(+34)934893000ppozo@vhebron.net

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2024

First Posted

November 5, 2024

Study Start

November 29, 2022

Primary Completion

April 30, 2025

Study Completion

May 1, 2025

Last Updated

November 13, 2024

Record last verified: 2024-11

Locations

ES(1)