Headache (Migraine)FASTNCT06674772
Molecular Phenotyping of Migraine Patients According to Sex and Age Through CGRP Quantification
An observational study of Headache (Migraine) and Migraine, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache (Migraine), Migraine, Migraine Headache
- What is being tested?
- Saliva test
- How many people
- 440 participants
- Where
- 1 siteSpain
- Study dates
- 29 Nov 2022to May 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Vall d'Hebron University Hospital
Barcelona, Barcelona, 08035
Patricia Pozo-Rosich, MD, PhD, (+34)934893000, ppozo@vhebron.net
About this study
Official title: Fenotipado Molecular De Pacientes Con Migraña Según Edad Y Sexo a Través De La Cuantificación De CGRP En Saliva Para Realizar Medicina De Precisión: Estudio FAST
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.
Read the 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.
- Conditions
- Headache (Migraine), Migraine, Migraine Headache, Migraine with Aura, Migraine Without Aura, Episodic Migraine
- Being tested
- Saliva test
- Keywords
- Migraine, CGRP, saliva
- Medical subject headings
- Migraine Disorders, Migraine with Aura, Migraine without Aura, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva testDiagnostic test
Also called Blood test
Sampling of CGRP in saliva and DNA blood test and sex hormones blood test.
| Study group | Role | What they receive |
|---|---|---|
| Migraine Patients | Patients, male and female, with Episodic migraine, all ages. Receives: Diagnostic Test: Saliva test | |
| Control group | Male and female without migraine or headache Receives: Diagnostic Test: Saliva test |
What is being measured
The primary outcome is the main question the study is designed to answer.
CGRP level
Measure of CGRP in saliva
Measured: 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.
Measured: Through study completion, an average of 1 year
DNA test
DNA testing for CGRP or its receptor related genes (CALCA, CALCB, CALCRL and RAMP1)
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start29 Nov 2022
- Primary completion30 Apr 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache (Migraine)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 440 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674772
- Sponsor's protocol ID
- PR(AG)350/2022
- Acronym
- FAST
- Status last verified
- Nov 2024
- First submitted
- 24 Oct 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided