Clinical trial Recruiting at 1 site Interventional Ages 18 to 50 Women only

Immune signals and regulatory T cells in migraine

Official title: Immune System, Inflammation, Migraine - The Role of Cytokines and Regulatory T Lymphocytes in Migraine Pathophysiology

Run by University Hospital, Clermont-Ferrand · NCT06426316 · Data updated 2026-11-12

This research will test whether blood immune markers and regulatory T cells are linked to migraine in women ages 18–50 who have migraine or certain autoimmune/inflammatory conditions.

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Quick facts

Study typeInterventional
Ages18 Years to 50 Years
SexWomen only
Enrollment396 (estimated)
SponsorUniversity Hospital, Clermont-Ferrand
Academic / other
Locations1 site (Clermont-Ferrand, AURA)
StatusRecruiting
StartedJune 2, 2025
Main results expectedApril 30, 2027
Study endsApril 30, 2027
Registry record updatedNovember 20, 2025
Trial IDNCT06426316 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Women aged 18–50 who weigh at least 50 kg and either have a diagnosed autoimmune/inflammatory condition listed (MS, SLE, RA, Crohn's, T1DM, endometriosis) or have migraine with at least four headache days per month.

Probably not a fit

Men, people outside the 18–50 age or specified BMI range, those with type 2 diabetes or other excluded chronic conditions, pregnant or breastfeeding women, and patients on excluded hormone treatments or with recent transplants are not eligible and unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-site study enrolls women aged 18–50 in two main groups: those with specified autoimmune or inflammatory diagnoses (MS, SLE, RA, Crohn's disease, type 1 diabetes, or endometriosis) and those with migraine (at least four headache days per month). Participants provide blood samples that will be analyzed for cytokines, neuropeptides and regulatory T cell numbers/function. Results will compare immune marker patterns between groups and explore correlations with migraine frequency and characteristics. The protocol involves only blood sampling and laboratory assays, with no therapeutic intervention.

Why it matters

Potential benefit: If successful, the findings could identify immune-related biomarkers or targets that help guide development of new migraine therapies.

How similar studies have gone: Previous work linking peptides like CGRP to migraine produced effective anti-CGRP treatments, but applying cytokine and regulatory T cell measurements to explain or treat migraine remains exploratory.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* female
* 18 - 50 years of age
* at least 50 kg
* autoimmune/inflammatory disease groups : with a diagnosis of multiple sclerosis, systemic lupus erythematous, rheumatoid arthritis, Crohn's disease, type 1 diabetes or endometriosis
* migraine group : with a diagnosis of migraine with at least 4 headache days per month

Exclusion Criteria:

* BMI \< or = 17 ou \> or = 30kg/m²
* type 2 diabetes, immune deficit, other chronic autoimmune or inflammatory disease
* non-migraine headache, except for tension type headache of less than 4 days/month
* pregnancy, delivery, miscarriage, breast-feeding, participation in a medically assisted human reproduction program (ovary stimulation/hormone therapy) \< 3 months before blood sampling
* Menopause, hysterectomy, or bilateral oophorectomy
* Hormone therapy (besides contraception and treatment of endometriosis)
* bone marrow or solid organ transplant
* guardianship, curatorship, safeguard of justice or deprivation of liberty
* for patients : diagnosis of several autoimmune or inflammatory diseases
* for controls : diagnosis of an autoimmune or inflammatory disease
* for non-migraine participants : migraine

Where it's running

  • CHU de Clermont-Ferrand - Service de Neurologie
    Clermont-Ferrand, Aura, France
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.