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临床试验/NCT07177885
NCT07177885招募中不适用

Tryptophan as a Modulating Factor in the Antimigraine Efficacy of Triptans

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2026年3月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
144
试验地点
1
主要终点
Plasma tryptophan levels

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

Migraineurs responding to triptans

Blood collection

干预措施: Blood collection (Biological)

Migraine sufferers resistant to triptans

Blood collection

干预措施: Blood collection (Biological)

结局指标

主要结局

Plasma tryptophan levels

时间窗: Baseline

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

次要结局

  • Blood nutritional biomarkers(Baseline)
  • 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)
  • Inflammatory bowel disorders(Baseline)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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