NCT04546698: 5-HTSEP

5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis

Completed Last updated 17 February 2022

What this trial tests

trial testing blood sampling in Multiple Sclerosis, Acute Relapsing in 78 participants. Completed in 19 July 2021.

Timeline

7 September 2020

Primary endpoint
19 July 2021

19 July 2021

Quick facts

Lead sponsor	Centre Hospitalier Régional d'Orléans
Status	Completed
Study type	OBSERVATIONAL
Enrollment	78
Start date	7 September 2020
Primary completion	19 July 2021
Estimated completion	19 July 2021
Sites	1 location across France

Drugs / interventions tested

• blood sampling — full drug profile →

Conditions studied

• Multiple Sclerosis, Acute Relapsing — all drugs for Multiple Sclerosis, Acute Relapsing →
• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

Centre Hospitalier Régional d'Orléans

Who can join

Adults 18 to 50, any sex, with Multiple Sclerosis, Acute Relapsing or Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Multiple Sclerosis is a chronic autoimmune disease associated with inflammatory response harmful for the Central Nervous System. Immunological imbalance is involved with Th1 and Th17 cells in correlation with a disturbance of regulators mechanisms as Treg cells. Despite years of research, the mechanisms involved remain unclear.

Serotonin (5-HT) seems to be a therapeutic target to treat multiple sclerosis. Indeed, several studies have shown the anti-inflammatory potential of this neurotransmitter and also its vulnerability in inflammatory context. Moreover, a recent study has shown that 5-HT can reduced CD4 T cells proliferation and pro-inflammatory cytokines released in vitro.

5-HT protector effects have also demonstrated in Experimental Autoimmune Encephalomyelitis mouse model (EAE) with an inflammatory response reduction and also a decreased of spinal cord lesions.

The latest receptor discovered, the 5-HT7 receptor, has been identify as a promise target to treat neurological disorders associated with inflammatory context. Present in humans and mice, this receptor spreads on the surface of a large number of cells, such as T-lymphocytes, macrophages, dendritic cells and also neurons, astrocytes and microglia.

Given the importance of the positive cells for 5-HT7 receptor, in the inflammatory context observed in multiple sclerosis, The investigator propose to study the receptor expression in blood samples from multiple sclerosis patient.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Microglia in Neuroinflammation and Neurodegeneration: From Understanding to Therapy.
   Muzio L, Viotti A, Martino G. · · 2021 · cited 413× · PMID 34630027 · DOI 10.3389/fnins.2021.742065
2. Targeting 5-HT Is a Potential Therapeutic Strategy for Neurodegenerative Diseases.
   Xing C, Chen H, Bi W, Lei T, et al · · 2024 · cited 8× · PMID 39769209 · DOI 10.3390/ijms252413446
3. T Lymphocyte Serotonin 5-HT₇ Receptor Is Dysregulated in Natalizumab-Treated Multiple Sclerosis Patients.
   Reverchon F, Guillard C, Mollet L, Auzou P, et al · · 2022 · cited 7× · PMID 36289679 · DOI 10.3390/biomedicines10102418