NCT06426316 The Role of Cytokines and Regulatory T Lymphocytes in Migraine Pathophysiology.
| NCT ID | NCT06426316 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Clermont-Ferrand |
| Condition | Migraine Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 396 participants |
| Start Date | 2025-06-02 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 396 participants in total. It began in 2025-06-02 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Migraine is a frequent and debilitating neurologic disorder. It is more frequent in women, and more prevalent in patients with autoimmune and/or inflammatory diseases such as multiple sclerosis (MS), rheumatoid arthritis (RA), Crohn's disease (CD), systemic lupus erythematosus (SLE) and endometriosis, whereas patients with long standing type 1 diabetes mellitus (T1DM) - an autoimmune but non inflammatory disease - seem to be less affected compared to the general population. Despite new migraine prevention treatments, a large number of patients remain unresponsive to currently available anti-migraine therapy and migraine pathophysiology remains unclear. Several peptides (calcitonin gene-related peptide (CGRP), pituitary adenylate cyclase activating peptide-38 (PACAP-38), vasoactive intestinal polypeptide (VIP)) and hormones (estrogens, prolactin) and the immune system play an important role in migraine pathophysiology. Among T lymphocytes, regulatory T (Treg) cells suppress inflammation. Studies have evidenced higher levels of inflammatory molecules (cytokines) in migraine patients and have suggested decreased proportions of Treg cells in migraine, as well as in MS, RA, CD and SLE, whereas inflammation declines and Treg levels seem increased in long-standing T1DM. Inflammation, which participates in migraine pain, seems to be a common factor for migraine and these diseases. However, these studies display conflicting results and further investigation is required to better understand the mechanisms behind migraine. In this study, the investigators will compare Treg levels, as well as identify Treg subpopulations and measure cytokine levels in migraine and migraine-free participants with and without an autoimmune/inflammatory disorder (MS, RA, CD, SLE, T1DM and endometriosis).
Eligibility 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
Contact & Investigator
Xavier MOISSET
PRINCIPAL INVESTIGATOR
University Hospital, Clermont-Ferrand
Frequently Asked Questions
Who can join the NCT06426316 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Migraine Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06426316 currently recruiting?
Yes, NCT06426316 is actively recruiting participants. Contact the research team at promo_interne_drci@chu-clermontferrand.fr for enrollment information.
Where is the NCT06426316 trial being conducted?
This trial is being conducted at Clermont-Ferrand, France.
Who is sponsoring the NCT06426316 clinical trial?
NCT06426316 is sponsored by University Hospital, Clermont-Ferrand. The principal investigator is Xavier MOISSET at University Hospital, Clermont-Ferrand. The trial plans to enroll 396 participants.
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