MigraineTRP-TriptansNCT07177885
Tryptophan as a Modulating Factor in the Antimigraine Efficacy of Triptans
An observational study of Migraine, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Migraine
- What is being tested?
- Blood collection
- How many people
- 144 participants
- Where
- 1 siteFrance
- Study dates
- 5 Mar 2026to Mar 2028
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients under guardianship, curatorship, deprivation of liberty, or legal protection
- Pregnant and breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand
Lise Laclautre, promo_interne_drci@chu-clermontferrand.fr
Xavier Moisset
About this study
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.
Read the 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
- Being tested
- Blood collection
- Keywords
- Triptan, Tryptophan, inflammatory diseases
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Migraineurs responding to triptans | Blood collection Receives: Biological: Blood collection | |
| Migraine sufferers resistant to triptans | Blood collection Receives: Biological: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma tryptophan levels
Variation in plasma tryptophan levels between triptan-resistant and triptan-responsive migraine patients.
Measured: Baseline
Secondary outcomes (7)
Serotonin levels
Variation in plasma serotonin levels between triptan-resistant and triptan-responsive migraine patients.
Measured: Baseline
Kynurenine levels
Variation in plasma kynurenine levels between triptan-resistant and triptan-responsive migraine patients.
Measured: Baseline
Levels of neutral amino acids
Variation in plasma levels of neutral amino acids between triptan-resistant and triptan-responsive migraine patients.
Measured: Baseline
Levels of cytokines (IL-6, IL-10, IL-1α, IL-1β)
Variation in plasma levels of cytokines (IL-6, IL-10, IL-1α, IL-1β) between triptan-resistant and triptan-responsive migraine patients.
Measured: Baseline
Dietary tryptophan intake
Dietary tryptophan intake via a self-questionnaire on eating habits
Measured: Baseline
Inflammatory bowel disorders
Presence/absence of inflammatory bowel disorders
Measured: Baseline
Blood nutritional biomarkers
Variation in blood nutritional biomarkers (glycemia, cholesterol)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start5 Mar 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Cross-sectional
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- University of the Basque Country (UPV/EHU), Hopital Lariboisière
- Responsible party
- Sponsor
- Investigators
- Xavier Moisset, Principal investigator, University Hospital, Clermont-FerrandCristina Alba-Delgado, Principal investigator, Université d'Auvergne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177885
- Sponsor's protocol ID
- RBHP 2025 MOISSET 4
- Other IDs
- 2025-A01152-47
- Acronym
- TRP-Triptans
- Status last verified
- Mar 2026
- First submitted
- 10 Sep 2025
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tryptophan as a Modulating Factor in the Antimigraine Efficacy of Triptans
- ClinicalTrials.gov ID
- NCT07177885
- Acronym / sponsor ID
- TRP-Triptans / RBHP 2025 MOISSET 4
- Conditions
- Migraine
- Keywords
- Triptan, Tryptophan, inflammatory diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- University of the Basque Country (UPV/EHU), Hopital Lariboisière
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 17 Sep 2025 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Migraineurs responding to triptans | – | Biological: Blood collectionBlood collection |
| Migraine sufferers resistant to triptans | – | Biological: Blood collectionBlood collection |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (2 listed)
- Patients under guardianship, curatorship, deprivation of liberty, or legal protection
- Pregnant and breastfeeding women
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 |
|---|---|---|
| Blood collectionBlood 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. | Biological | Migraine sufferers resistant to triptans, Migraineurs responding to triptans |
Primary outcome
Plasma tryptophan levels
Time frame: Baseline
Variation in plasma tryptophan levels between triptan-resistant and triptan-responsive migraine patients.
7 secondary outcomes
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
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 9 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Xavier Moisset principal investigator
University Hospital, Clermont-Ferrand
Cristina Alba-Delgado principal investigator
Université d'Auvergne
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 Migraine, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 7 inclusion and 2 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 9 Mar 2026. 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 France. 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 Lise Laclautre (0033473754027, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma tryptophan levels (time frame: Baseline). 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 9 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.