NCT06426316Recruiting
The Role of Cytokines and Regulatory T Lymphocytes in Migraine Pathophysiology.
Immune System, Inflammation, Migraine - The Role of Cytokines and Regulatory T Lymphocytes in Migraine Pathophysiology
Source: ClinicalTrials.gov · Last updated 20 Nov 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 396 (estimated)
- First submitted
- 30 Apr 2024
- Start date
- 2 Jun 2025
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- University Hospital, Clermont-Ferrand
- NCT number
- NCT06426316
What you commit to
- Study type: Interventional
- Planned participants: 396
- From 2 Jun 2025 to the primary completion date, 30 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 50 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Clermont-Ferrand - Service de Neurologie Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.