Immune signals and regulatory T cells in migraine
Immune System, Inflammation, Migraine - The Role of Cytokines and Regulatory T Lymphocytes in Migraine Pathophysiology
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 396 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 1 site (Clermont-Ferrand, AURA) |
| Trial ID | NCT06426316 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Clermont-Ferrand, AURA
- CHU de Clermont-Ferrand - Service de Neurologie — Clermont-Ferrand, Aura, France (Recruiting)
Study contacts
- Principal investigator: Xavier MOISSET — University Hospital, Clermont-Ferrand
- Study coordinator: Lise LACLAUTRE
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 334.73.754.963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.