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Recruiting NCT07177885

Tryptophan as a Modulating Factor in the Antimigraine Efficacy of Triptans

Observational Migraine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood collection.
Who it may be relevant to
Registry conditions: Migraine. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Biological 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.

Primary outcome measures

  • Plasma tryptophan levels [Time frame: Baseline]
Secondary outcome measures (7)
  • Serotonin levels [Time frame: Baseline]
  • Kynurenine levels [Time frame: Baseline]
  • Levels of neutral amino acids [Time frame: Baseline]
  • Levels of cytokines (IL-6, IL-10, IL-1α, IL-1β) [Time frame: Baseline]
  • Dietary tryptophan intake [Time frame: Baseline]
  • Inflammatory bowel disorders [Time frame: Baseline]
  • Blood nutritional biomarkers [Time frame: Baseline]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

France · 1 center
  • CHU de Clermont-Ferrand — Clermont-Ferrand

Identifiers

NCT: NCT07177885 · RBHP 2025 MOISSET 4 · 2025-A01152-47

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗