The Role of Cytokines and Regulatory T Lymphocytes in Migraine Pathophysiology.
Not applicable · Testing Blood test · 1 site · University Hospital, Clermont-Ferrand
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Blood test (a biologic) to better understand how the disease works. Condition(s) listed: Migraine Disorders, Pain and Autoimmune Diseases.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 50
- Women only
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- female
- 18 - 50 years of age
- at least 50 kg
Plus 2 more requirement(s). There are also 11 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 396 participants are expected to take part.
- Start date: 2025-06-02.
- Main results expected around 2027-04-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in France.
Main thing being measured
- Treg cell levels in cell/microliter (cell/µL) and percentage (%) of white blood cells (Once, at inclusion)
In the researchers’ words
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 -…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Migraine Disorders; Pain; Autoimmune Diseases; Multiple Sclerosis; Endometriosis; Rheumatoid Arthritis; Crohn Disease; Lupus Erythematosus |
| Lead sponsor | University Hospital, Clermont-Ferrand |
| Enrollment | 396 (estimated) |
| Start date | 2025-06-02 |
| Primary completion (est.) | 2027-04-30 |
| First posted | 2024-05-23 |
| Last updated | 2025-11-20 |
| Official title | Immune System, Inflammation, Migraine - The Role of Cytokines and Regulatory T Lymphocytes in Migraine Pathophysiology |
| ClinicalTrials.gov ID | NCT06426316 |
Interventions
- Blood test (Biological)
1 blood test of maximum 40 millilitres per patient
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Clermont-Ferrand - Service de Neurologie | Clermont-Ferrand, AURA | France | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.