Tryptophan as a Modulating Factor in the Antimigraine Efficacy of Triptans

NCT ID: NCT07177885

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 144 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2028-11-30

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.

Detailed Description

Migraine is a leading cause of disability worldwide. Triptans are medications used to treat migraine attacks. They work mainly in two ways: by narrowing the blood vessels in the brain and by stopping the release of substances that cause pain and inflammation. Triptans help relieve migraine pain and other symptoms, like digestive problems, light sensitivity, and disability during an attack. However, more than 20% of patients do not respond well to these medications, and the reasons for this are not well understood.

Tryptophan is an essential amino acid, which means it must come from food because the body cannot produce it. Tryptophan plays an important role in migraines, especially through its by-products, such as serotonin and kynurenine. Research has shown that problems with tryptophan metabolism can make migraines worse, along with other sensory symptoms.

Although no study has directly linked tryptophan to the effectiveness of triptans, the investigators found in a preclinical study that a low-tryptophan diet could reduce the effectiveness of sumatriptan, one of the most commonly used triptans. A deficiency in tryptophan can occur when the body has trouble absorbing it from the intestines. Conditions like inflammatory bowel diseases (such as irritable bowel syndrome or Crohn's disease) or diabetes can affect this absorption, which might reduce the body's ability to process tryptophan.

This study aims to better understand how tryptophan might affect resistance to triptans in migraine patients. The investigators will compare blood levels of tryptophan and its by-products in patients who respond well to triptans versus those who do not. If participants are having a lumbar puncture as part of their regular check-up, the investigators will also examine these substances in the cerebrospinal fluid. Additionally, the investigators will explore any connection between tryptophan metabolism and inflammatory bowel disease.

Conditions

Migraine

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Migraineurs responding to triptans

Blood collection

Blood collection

Intervention Type: BIOLOGICAL

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 triptans

Blood collection

Blood collection

Intervention Type: BIOLOGICAL

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.

Interventions

Blood collection

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of the Basque Country (UPV/EHU)

OTHER

Sponsor Role: collaborator

Lariboisière Hospital

UNKNOWN

Sponsor Role: collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xavier Moisset

Role: PRINCIPAL_INVESTIGATOR

CHU de Clermont-Ferrand

Cristina Alba-Delgado

Role: PRINCIPAL_INVESTIGATOR

Université d'Auvergne

Locations

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

Central Contacts

Lise Laclautre

Role: CONTACT

promo_interne_drci@chu-clermontferrand.fr

0033473754027

Facility Contacts

Lise Laclautre

Role: primary

promo_interne_drci@chu-clermontferrand.fr

Other Identifiers

2025-A01152-47

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2025 MOISSET 4

Identifier Type: -

Identifier Source: org_study_id