Suppressive Functions of Regulatory T Cells in Migraine
Launched by UNIVERSITY HOSPITAL, CLERMONT-FERRAND · Jul 4, 2025
Trial Information
Current as of July 22, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how certain immune cells called regulatory T cells (or Treg cells) work in women who have chronic migraine. Migraines are severe headaches that happen often and can be very disabling. Researchers believe that inflammation and the way the immune system behaves may play a role in why migraines become chronic, or long-lasting. Specifically, this study will explore whether these Treg cells, which usually help control inflammation and pain, are not working properly in people with migraines.
Women between the ages of 18 and 50 who experience chronic migraine (at least 15 headache days per month) may be eligible to join the study. To participate, they should not have other serious health conditions like diabetes, immune diseases, or certain types of headaches. If accepted, participants will likely undergo blood tests to help researchers understand how their immune cells function. This study is not yet recruiting, but it aims to provide new insights into migraine causes, which could help develop better treatments in the future.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Females
- • 18 to 50 years old
- • Chronic migraine participants : chronic migraine (at least 15 days of headache/month, according to the International Classification of Headache Disorders, 3rd edition criteria
- Exclusion Criteria:
- • BMI \< or = 17kg/m² or \> or = 30kg/m²
- • Diagnosis or suspicion of type 2 diabetes, auto-immune or inflammatory diseases, immunodeficiency diseases
- • Diagnosis of headache of non-migraine origin, except for tension type headache \< or = 4 days per month (i.e.: cluster headache, post-traumatic headache, cerebral tumour...)
- • Pregnancy, delivery, miscarriage, breastfeeding, participation in a medically assisted human reproduction program (ovary stimulation/hormone therapy) \< 3 months before blood sampling
- • Menopause, hysterectomy, or bilateral oophorectomy
- • Flare of the autoimmune/inflammatory disease of interest \< 1 month before blood sampling
- • Modification of maintenance therapy for the autoimmune/inflammatory disease of interest (start, change of molecule, interruption) \< 3 months before blood sampling
- • Modification of prophylactic anti-migraine therapy (start, change of molecule, interruption) \< 3 months before blood sampling (for migraine participants)
- • Hormone therapy (besides contraception and treatment of endometriosis)
- • Transplantation (solid organ or bone marrow)
- • Cancer (active or remitting) \< 1 year before blood sampling (solid organ or blood)
- • Haematologic disease (benign or malignant) of the lymphoid lineage
- • Guardianship, curatorship, safeguard of justice or deprivation of liberty
- • For controls : diagnosis of migraine
About University Hospital, Clermont Ferrand
The University Hospital of Clermont-Ferrand is a leading academic medical institution dedicated to advancing healthcare through innovative research and clinical trials. Renowned for its multidisciplinary approach, the hospital integrates cutting-edge scientific inquiry with patient care, fostering an environment that promotes collaboration among healthcare professionals, researchers, and academic partners. With a strong commitment to improving patient outcomes, the institution actively engages in a wide array of clinical studies, ranging from early-phase trials to large-scale interventions, aimed at addressing critical health challenges and enhancing treatment modalities. Its state-of-the-art facilities and expertise make it a pivotal contributor to clinical research in the region and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Clermont Ferrand, , France
Patients applied
Trial Officials
Xavier MOISSET
Principal Investigator
University Hospital, Clermont-Ferrand
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported