NCT07177885

Brief Summary

Migraine is a leading cause of disability, and while triptans are commonly used to treat migraine attacks, over 20% of patients don't respond well to them. This study aims to understand why some people don't benefit from triptans. One key focus is tryptophan, an amino acid that plays a role in migraine and is involved in producing serotonin, which affects pain and inflammation. The study will compare levels of tryptophan and its by-products in patients who respond well to triptans versus those who don't. It will also look at how conditions like inflammatory bowel disease may affect tryptophan absorption. The goal is to improve migraine treatments tailored to different patient needs, though participants may not experience immediate personal benefits.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
22mo left

Started Mar 2026

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

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Study Timeline

Key milestones and dates

Study Progress9%
Mar 2026Mar 2028

First Submitted

Initial submission to the registry

September 10, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 17, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

March 5, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

September 10, 2025

Last Update Submit

March 6, 2026

Conditions

Migraine

Keywords

TriptanTryptophaninflammatory diseases

Outcome Measures

Primary Outcomes (1)

  • Plasma tryptophan levels

    Variation in plasma tryptophan levels between triptan-resistant and triptan-responsive migraine patients.

    Baseline

Secondary Outcomes (7)

  • Serotonin levels

    Baseline

  • Kynurenine levels

    Baseline

  • Levels of neutral amino acids

    Baseline

  • Levels of cytokines (IL-6, IL-10, IL-1α, IL-1β)

    Baseline

  • Dietary tryptophan intake

    Baseline

  • +2 more secondary outcomes

Other Outcomes (2)

  • Hospital Anxiety and Depression Scale

    Baseline

  • Headache Impact

    Baseline

Study Arms (2)

Migraineurs responding to triptans

Blood collection

Biological: Blood collection

Migraine sufferers resistant to triptans

Blood collection

Biological: Blood collection

Interventions

Blood collectionBIOLOGICAL

Blood sampling. For patients who have had their cerebrospinal fluid sample taken as part of their treatment, a surplus sample will be used to perform the same measurements.

Migraine sufferers resistant to triptansMigraineurs responding to triptans

Eligibility Criteria

Age18 Years - 50 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details* Cisgender women, premenopausal, between 18 and 50 years old. * Cisgender men between 18 and 50 years old.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Participants in the study will be recruited from the following centers: * Centre 01: CHU de Clermont-Ferrand, Gabriel Montpied site, located at 58 Rue Montalembert, 63000 Clermont-Ferrand, France. * Centre 02: Headache Emergency Center, Hôpital Lariboisière, located at 2 Rue Ambroise Paré, 75010 Paris, France.

You may qualify if:

  • Cisgender women, premenopausal, aged 18 to 50 years.
  • Cisgender men, aged 18 to 50 years.
  • Diagnosed with migraine (according to ICHD-3 criteria).
  • Diagnosed as responders or non-responders to triptans (according to the criteria of Sacco et al., 2022).
  • Permitted comparison groups include: triptans used alone or in combination with other migraine treatments (e.g., NSAIDs, acetaminophen, ergotamine, opioids, antiemetics).
  • All routes of administration and all dosages.
  • Affiliation with a social security system.

You may not qualify if:

  • Patients under guardianship, curatorship, deprivation of liberty, or legal protection
  • Pregnant and breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Migraine Disorders

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Xavier Moisset

    CHU de Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

  • Cristina Alba-Delgado

    Université d'Auvergne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

0033473754027promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2025

First Posted

September 17, 2025

Study Start

March 5, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)