Multiple Sclerosis, Acute Relapsing5-HTSEPNCT04546698
5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
An observational study of Multiple Sclerosis, Acute Relapsing and Multiple Sclerosis, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Acute Relapsing, Multiple Sclerosis
- What is being tested?
- blood sampling
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- 7 Sep 2020to 19 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Man and Woman 18 to 50 years old
Who may be able to join
- 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)
Who cannot join
- without social security
- HIV positive serology
- infectious status in the past month
- corticosteroid therapy in the past month
- dementia
- pregnant or breastfeeding woman
Show all 9Show fewer
- previous participation in the study
- under judicial protection
- non-cooperating patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 5-HTSEP: Serotonin 5-HT7 Receptor Implication in the Inflammatory Mechanisms in Multiple Sclerosis
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.
Read more
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.
Read the detailed description
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)
- 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.
- 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.
- 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.
- 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.
- 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.
- Being tested
- blood sampling
- Keywords
- Multiple sclerosis, serotonin, 5-HT7 receptor, inflammation, lymphocytes, cytokines
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis patients with an acute relapse | Multiple Sclerosis diagnosed according to Mc Donald's criteria with an acute relapse Receives: Other: blood sampling | |
| Multiple sclerosis pataients treated with Natalizumab | Multiple Sclerosis patients diagnosed according to Mc Donald's criteria and treated with Natalizumab since 6 cures Receives: Other: blood sampling | |
| Healthy people | Not described Receives: Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
5HT7 Serotonin receptor expression on circulating leukocyte cells
To analyze the 5-HT7 expression on circulating leukocyte cells, we will perform flow cytometry studies from the whole blood of the three groups mentioned above. In a first step, we 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, we will precise which cell type, among the lymphocytes implicated in the MS pathology, express the 5-HT7 receptor. We will use antibodies against each population: Thelper 1 cell, Thelper 2 cell, Thelper 17 cell and Treg. We will also perform immunostaining on Cytospin (thin layer of blood cells on coverslips) to visualize co-labeling and confirm the results of flow cytometry.
Measured: Baseline
5-HT7 Serotonin receptor mRNA quantity
For the three groups, we will determine the 5-HT7 mRNA quantity on circulating leukocyte cells. In a first step, we 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, we will perform cell sorting to isolate Thelper 1 cell, Thelper 2 cell , Thelper 17 cell and Treg cells and specifically extract 5-HT7 mRNA.
Measured: Baseline
Immunological context on blood samples
We will identify the immune context by ELISA dosage from serum samples. We will investigate on pro-inflammatory markers like Interleukin 1b, IFNg, IL17 and anti-inflammatory markers like Interleukin 10 and Interluekin 4.
Measured: Baseline
5-HT7 receptor role on lymphocyte functions in vitro
From blood samples of the three groups mentioned above, we will isolate peripheral blood mononuclear cells (PBMC) in vitro, to evaluate the 5-HT7 receptor role on their function to produce and release cytokines. We will stimulate PBMC with one or more 5-HT7 ligands, and we 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.
Measured: Baseline
5-HT7 receptor isoforms 5-HT7 receptor isoforms
There are three forms of 5-HT7 receptor (5-HT7a, 5-HT7b, 5-HT7d). We 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start7 Sep 2020
- Primary completion19 Jul 2021
- Study completion19 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Acute RelapsingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Collaborators
- National Scientific Research Centre
- Responsible party
- Sponsor
- Investigators
- Maud PALLIX, MD, Principal investigator, CHR ORLEANS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546698
- Sponsor's protocol ID
- CHRO-2020-01
- Acronym
- 5-HTSEP
- Status last verified
- Feb 2022
- First submitted
- 31 Aug 2020
- Last updated
- 17 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, Correale J, Fazekas F, Filippi M, Freedman MS, Fujihara K, Galetta SL, Hartung HP, Kappos L, Lublin FD, Marrie RA, Miller AE, Miller DH, Montalban X, Mowry EM, Sorensen PS, Tintore M, Traboulsee AL, Trojano M, Uitdehaag BMJ, Vukusic S, Waubant E, Weinshenker BG, Reingold SC, Cohen JA. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2. Epub 2017 Dec 21.
PubMed 29275977Sacramento PM, Monteiro C, Dias ASO, Kasahara TM, Ferreira TB, Hygino J, Wing AC, Andrade RM, Rueda F, Sales MC, Vasconcelos CC, Bento CAM. Serotonin decreases the production of Th1/Th17 cytokines and elevates the frequency of regulatory CD4+ T-cell subsets in multiple sclerosis patients. Eur J Immunol. 2018 Aug;48(8):1376-1388. doi: 10.1002/eji.201847525. Epub 2018 Jun 6.
PubMed 29719048Yuan XQ, Qiu G, Liu XJ, Liu S, Wu Y, Wang X, Lu T. Fluoxetine promotes remission in acute experimental autoimmune encephalomyelitis in rats. Neuroimmunomodulation. 2012;19(4):201-8. doi: 10.1159/000334095. Epub 2012 Mar 21.
PubMed 22441536Quintero-Villegas A, Valdes-Ferrer SI. Role of 5-HT7 receptors in the immune system in health and disease. Mol Med. 2019 Dec 31;26(1):2. doi: 10.1186/s10020-019-0126-x.
PubMed 31892309
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5-HTSEP: Serotonin 5-HT7 Receptor Implication in the Inflammatory Mechanisms in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04546698
- Acronym / sponsor ID
- 5-HTSEP / CHRO-2020-01
- Keywords
- Multiple sclerosis, serotonin, 5-HT7 receptor, inflammation, lymphocytes, cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Collaborators
- National Scientific Research Centre
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 19 Jul 2021 (actual)
- Study completion
- 19 Jul 2021 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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)
- 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.
- 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.
- 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.
- 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.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis patients with an acute relapse | – | Other: blood samplingMultiple Sclerosis diagnosed according to Mc Donald's criteria with an acute relapse |
| Multiple sclerosis pataients treated with Natalizumab | – | Other: blood samplingMultiple Sclerosis patients diagnosed according to Mc Donald's criteria and treated with Natalizumab since 6 cures |
| Healthy people | – | Other: blood sampling |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Man and Woman 18 to 50 years old
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- without social security
- HIV positive serology
- infectious status in the past month
- corticosteroid therapy in the past month
- dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingAnalyse 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 | Other | Healthy people, Multiple Sclerosis patients with an acute relapse, Multiple sclerosis pataients treated with Natalizumab |
Primary outcome
5HT7 Serotonin receptor expression on circulating leukocyte cells
Time frame: Baseline
To analyze the 5-HT7 expression on circulating leukocyte cells, we will perform flow cytometry studies from the whole blood of the three groups mentioned above. In a first step, we 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, we will precise which cell type, among the lymphocytes implicated in the MS pathology, express the 5-HT7 receptor. We will use antibodies against each population: Thelper 1 cell, Thelper 2 cell, Thelper 17 cell and Treg. We will also perform immunostaining on Cytospin (thin layer of blood cells on coverslips) to visualize co-labeling and confirm the results of flow cytometry.
5-HT7 Serotonin receptor mRNA quantity
Time frame: Baseline
For the three groups, we will determine the 5-HT7 mRNA quantity on circulating leukocyte cells. In a first step, we 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, we will perform cell sorting to isolate Thelper 1 cell, Thelper 2 cell , Thelper 17 cell and Treg cells and specifically extract 5-HT7 mRNA.
Immunological context on blood samples
Time frame: Baseline
We will identify the immune context by ELISA dosage from serum samples. We will investigate on pro-inflammatory markers like Interleukin 1b, IFNg, IL17 and anti-inflammatory markers like Interleukin 10 and Interluekin 4.
5-HT7 receptor role on lymphocyte functions in vitro
Time frame: Baseline
From blood samples of the three groups mentioned above, we will isolate peripheral blood mononuclear cells (PBMC) in vitro, to evaluate the 5-HT7 receptor role on their function to produce and release cytokines. We will stimulate PBMC with one or more 5-HT7 ligands, and we 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-HT7 receptor isoforms 5-HT7 receptor isoforms
Time frame: Baseline
There are three forms of 5-HT7 receptor (5-HT7a, 5-HT7b, 5-HT7d). We 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Background: PubMed 29275977Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, Correale J, Fazekas F, Filippi M, Freedman MS, Fujihara K, Galetta SL, Hartung HP, Kappos L, Lublin FD, Marrie RA, Miller AE, Miller DH, Montalban X, Mowry EM, Sorensen PS, Tintore M, Traboulsee AL, Trojano M, Uitdehaag BMJ, Vukusic S, Waubant E, Weinshenker BG, Reingold SC, Cohen JA. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2. Epub 2017 Dec 21.
- Results publication: PubMed 29719048Sacramento PM, Monteiro C, Dias ASO, Kasahara TM, Ferreira TB, Hygino J, Wing AC, Andrade RM, Rueda F, Sales MC, Vasconcelos CC, Bento CAM. Serotonin decreases the production of Th1/Th17 cytokines and elevates the frequency of regulatory CD4+ T-cell subsets in multiple sclerosis patients. Eur J Immunol. 2018 Aug;48(8):1376-1388. doi: 10.1002/eji.201847525. Epub 2018 Jun 6.
- Results publication: PubMed 22441536Yuan XQ, Qiu G, Liu XJ, Liu S, Wu Y, Wang X, Lu T. Fluoxetine promotes remission in acute experimental autoimmune encephalomyelitis in rats. Neuroimmunomodulation. 2012;19(4):201-8. doi: 10.1159/000334095. Epub 2012 Mar 21.
- Results publication: PubMed 31892309Quintero-Villegas A, Valdes-Ferrer SI. Role of 5-HT7 receptors in the immune system in health and disease. Mol Med. 2019 Dec 31;26(1):2. doi: 10.1186/s10020-019-0126-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maud PALLIX, MD principal investigator
CHR ORLEANS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, Acute Relapsing and Multiple Sclerosis, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5HT7 Serotonin receptor expression on circulating leukocyte cells (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04546698, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.