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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 50 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Man and Woman.
  • - 18 to 50 years old.
  • - Multiple Sclerosis diagnosed according to Mc Donald's criteria (Thompson et al.
2018)
  • - With an acute relapse (group 1) - Stable with Natalizumab treatment (group 2), minimum 6 Natalizumab cures.
  • - Healthy Volunteers (group 3)

    Exclusion Criteria:

    - without social security.
  • - HIV positive serology.
  • - infectious status in the past month.
  • - corticosteroid therapy in the past month.
  • - dementia.
  • - pregnant or breastfeeding woman.
  • - previous participation in the study.
  • - under judicial protection.
- non-cooperating patient

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04546698
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Centre Hospitalier Régional d'Orléans
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Maud PALLIX, MD
Principal Investigator Affiliation CHR ORLEANS
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Sclerosis, Acute Relapsing, Multiple Sclerosis
Additional Details

The expression modulation of 5-HT7 receptor will be investigate in correlation with the immunological context, in different group of MS patients:

  • - Group 1: MS patients with an acute relapse.
  • - Group 2: MS stable patients treated with Natalizumab.
  • - Group 3: Healthy people (from Etablissement Français du Sang) 1.
5-HT7 receptor expression evaluation on circulating leukocyte cells Each group presents a different inflammatory context. The investigator wish to determine the immunological context influence on the 5-HT7 receptor expression and which cells express it. To analyze the 5-HT7 expression on circulating leukocyte cells, The investigator will perform flow cytometry studies from the whole blood of the three groups mentioned above. In a first step, the investigator will analyze the overall rate of 5-HT7 circulating positive cells by the use of an antibody against 5-HT7 receptor whose specificity was validated in our research team. In a second step, the investigator will precise which cell type, among the lymphocytes implicated in the MS pathology, express the 5-HT7 receptor. The investigator will use antibodies against each population t helper cell: Th1 , Th2, Th17 and Treg. The investigator will also perform immunostaining on Cytospin (thin layer of blood cells on coverslips) to visualize co-labeling and confirm the results of flow cytometry. 2. Correlation between 5-HT7 receptor expression and mRNA quantity In addition, a correlation has been shown between an increase of 5-HT7 positive cells and an mRNA quantity up regulated. For the three groups, the investigator will determine the 5-HT7 mRNA quantity on circulating leukocyte cells. In a first step, the investigator will check correlation between the 5-HT7 receptor expression rate and the mRNA quantity on circulating leukocyte cells, using quantitative Polymerase Chain Reaction (qPCR). In a second step, the investigator will perform cell sorting to isolate Th1, Th2, Th17 and Treg cells and specifically extract 5-HT7 mRNA. In this way, the investigator can address the 5-HT7 receptor role on one or more specific cell types on the MS. 3. 5-HT7 receptor modulation according to the immunological context In order to understand the 5-HT7 receptor potential role on immune response moderation, the investigator will identify the immune context by ELISA dosage from serum samples. The investigator will investigate on pro-inflammatory markers like IL1b, IFNg, IL17 and anti-inflammatory markers like IL10 and IL4. These results will be correlated with the previous results concerning the 5-HT7 receptor expression/quantity for each patient groups. 4. 5-HT7 receptor role on lymphocyte functions in vitro From blood samples of the three groups mentioned above, the investigator will isolate peripheral blood mononuclear cells (PBMC) in vitro, to evaluate the 5-HT7 receptor role on their function to produce and release cytokines. The investigator will stimulate PBMC with one or more 5-HT7 ligands, and will perform ELISA dosage from supernatant with pro-inflammatory markers like IL1b, IFNg, IL17 and anti-inflammatory markers like IL10 and IL4. The cell immunolabelling will be perform to visualize 5-HT7 receptor on the cell surface. 5. Identification of 5-HT7 receptor isoforms There are three forms of 5-HT7 receptor (5-HT7a, 5-HT7b, 5-HT7d). However, no difference has yet been described for their pharmacological function. The investigator propose to identify these different isoforms by qPCR. As previously described, in a first step, on circulating leukocyte cells and in a second step, after cell sorting to isolate Th1, Th2, Th17 and Treg cells.

Arms & Interventions

Arms

: Multiple Sclerosis patients with an acute relapse

Multiple Sclerosis diagnosed according to Mc Donald's criteria with an acute relapse

: Multiple sclerosis pataients treated with Natalizumab

Multiple Sclerosis patients diagnosed according to Mc Donald's criteria and treated with Natalizumab since 6 cures

: Healthy people

Interventions

Other: - blood sampling

Analyse of expression modulation of 5-HT7 receptor in correlation with the immunological context, in 3 differents groups : 2 with multiple sclerosis patients, one healthy volunteers group

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHR Orléans, Orléans, France

Status

Recruiting

Address

CHR Orléans

Orléans, , 45067

Site Contact

MAUD PALLIX-GUYOT, MD

[email protected]

33238514444

Nearest Location

Site Contact

MAUD PALLIX-GUYOT, MD

[email protected]

33238514444


Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

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NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

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Visit NARCOMS

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If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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