SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03850301

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

An Experimental Medicine Study to Validate the 18 kiloDalton Translocator Protein (TSPO) as a Novel Neuroimmunodulatory Target in Multiple Sclerosis

In multiple sclerosis (MS) cells of the immune system attack the brain causing tissue damage. In secondary progressive MS (SPMS) these repeated immune attacks have stopped but despite this new damage continues to appear. TSPO is a protein found in the brain and cells of the immune system, whose levels increase during MS. The investigators would like to know whether drugs that bind TSPO could dampen the immune responses in patients with SPMS. The investigators will be testing two drugs that affect TSPO; etifoxine and XBD173. Subjects with SPMS will be recruited from neurology clinics at hospitals associated with Imperial College Healthcare NHS Trust. Healthy volunteers will also be recruited in order to provide a comparison to these patients. The volunteers recruited will be invited to the clinical research facility (CRF) at Hammersmith Hospital. The volunteers will take one of the two drugs every day for 7 days. The researchers will perform blood tests before the first dose and after the last dose to investigate the effects of the drugs, including the expression of genes and immune cell activity. This will allow the researchers to explore which of the two drugs produces the greatest changes in the amount of TSPO in the blood in MS patients relative to healthy controls.

NCT03850301 Multiple Sclerosis
MeSH: Sclerosis Multiple Sclerosis

2 Interventions

Name: XBD173

Description: 7 days treatment

Type: Drug

Etifoxine then XBD173 XBD173 then Etifoxine

Name: Etifoxine

Description: 7 days treatment

Type: Drug

Etifoxine then XBD173 XBD173 then Etifoxine


Primary Outcomes

Description: Plasma cytokine concentrations

Measure: Monocyte phenotye - Tissue necrosis factor-α

Time: 7 days

Description: Plasma cytokine concentrations

Measure: Monocyte phenotye - Interferon-γ

Time: 7 days

Description: Plasma cytokine concentrations

Measure: Monocyte phenotype - Interleukins- 1β

Time: 7 days

Description: Plasma cytokine concentrations

Measure: Monocyte phenotype - Interleukins- 16

Time: 7 days

Description: Plasma cytokine concentrations

Measure: Monocyte phenotype - Interleukins- 17

Time: 7 days

Description: Plasma cytokine concentrations

Measure: Monocyte phenotype - Interleukins- 23

Time: 7 days

Description: Transforming growth factor-β

Measure: Immunomodulatory factor -Transforming growth factor-β

Time: 7 days

Description: Interleukins -4

Measure: Immunomodulatory factor - Interleukins -4

Time: 7 days

Description: Interleukins - 10

Measure: Immunomodulatory factor - Interleukins - 10

Time: 7 days

Description: Flow

Measure: Relative proportions of WBC subsets

Time: 7 days

Secondary Outcomes

Description: Genome, proteome, metabolome

Measure: Monocyte phenotype - 'omic analyses

Time: 7 days

Description: Plasma levels of neurofilament

Measure: Neurofilament

Time: 7 days

Purpose: Other

Allocation: Randomized

Crossover Assignment


There is one SNP

SNPs


1 rs6971

b To explore the potential dependence of these pharmacodynamic responses on variation at rs6971 (a common polymorphism influencing ligand binding affinities in the TSPO protein) in the TSPO gene.



HPO Nodes