Taking people in FranceNo phase

Blood Tests of Immune Cells and Inflammation in Migraine Patients

Compares immune cells and inflammation levels in blood of people with migraine.

Key facts

Who runs it: University Hospital, Clermont-Ferrand
Where: Clermont-Ferrand, FranceSee the site
Trial code: NCT06426316
Registry title: The Role of Cytokines and Regulatory T Lymphocytes in Migraine Pathophysiology.
Status: Recruiting
People taking part: 396 people, planned
Started: 2 Jun 2025
Expected to end: 30 Apr 2027
Type of study: Interventional, 4 groups
Treatments tested: Blood test
Record updated: 20 November 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women aged 18 to 50. Some have migraine, some have an autoimmune or inflammatory disease, and some have neither. A blood test is taken.

Age: 18 to 50 years
Sex: Women only
Disease stage: Migraine group: a migraine diagnosis with at least 4 headache days per month. Disease groups: multiple sclerosis, systemic lupus erythematous, rheumatoid arthritis, Crohn's disease, type 1 diabetes or endometriosis.
Earlier treatment: No hormone therapy, except contraception and treatment of endometriosis. No ovary stimulation or hormone therapy for medically assisted reproduction in the 3 months before blood sampling.

Main reasons for not taking part

BMI 17 or below, or 30 kg/m² or above
Type 2 diabetes, immune deficit, or another chronic autoimmune or inflammatory disease
Pregnancy, delivery, miscarriage or breast-feeding in the 3 months before blood sampling
Menopause, hysterectomy or removal of both ovaries
Bone marrow or solid organ transplant

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

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

Who cannot take part

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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 50 years old?

Where in France

CHU de Clermont-Ferrand - Service de NeurologieClermont-Ferrand, FranceContact: Xavier MOISSET (principal investigator)Taking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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).

The 4 groups in the trial

Migraine - no autoimmune/inflammatory diseaseTreatment being tested
Migraine - no autoimmune/inflammatory disease group
Treatment: Blood test
No migraine - no autoimmune/inflammatory diseaseTreatment being tested
No migraine - no autoimmune/inflammatory disease group
Treatment: Blood test
No migraine - autoimmune/inflammatory disease (MS, RA, CD, SLE, T1DM, endometriosis)Treatment being tested
No migraine - autoimmune/inflammatory disease (MS, RA, CD, SLE, T1DM, endometriosis) group
Treatment: Blood test
Migraine - autoimmune/inflammatory disease (MS, RA, CD, SLE, T1DM, endometriosis)Treatment being tested
Migraine - autoimmune/inflammatory disease (MS, RA, CD, SLE, T1DM, endometriosis) group
Treatment: Blood test