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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06674772
- Acronym / sponsor ID
- FAST / PR(AG)350/2022
- Conditions
- Headache (Migraine), Migraine, Migraine Headache, Migraine with Aura, Migraine Without Aura, Episodic Migraine
- Keywords
- Migraine, CGRP, saliva
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Migraine Patients | – | Diagnostic Test: Saliva testPatients, male and female, with Episodic migraine, all ages. |
| Control group | – | Diagnostic Test: Saliva testMale and female without migraine or headache |
Who may qualify
- Ages
- 6 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saliva testAlso: Blood testSampling of CGRP in saliva and DNA blood test and sex hormones blood test. | Diagnostic test | Control group, Migraine Patients |
Primary outcome
CGRP level
Time frame: Through study completion, an average of 1 year
Measure of CGRP in saliva
Hormone levels
Time frame: 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
Time frame: Through study completion, an average of 1 year
DNA testing for CGRP or its receptor related genes (CALCA, CALCB, CALCRL and RAMP1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache (Migraine) and Migraine, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia Pozo-Rosich, MD, PhD ((+34)934893000, ppozo@vhebron.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CGRP level (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.