Validation of the 18 kiloDalton Translocator Protein (TSPO) as a Novel
An Experimental Medicine Study to Validate the 18 kiloDalton Translocator Protein (TSPO) as a Novel Neuroimmunodulatory Target in Multiple Sclerosis
We could not find results for this trial
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Emapunil
Translocator protein agonist
- Etifoxine
GABA-A receptor; anion channel antagonist
What it measured
Main measures
Monocyte phenotye - Tissue necrosis factor-α
7 days
Immune responseMonocyte phenotye - Interferon-γ
7 days
Immune responseMonocyte phenotype - Interleukins- 1β
7 days
Immune responseMonocyte phenotype - Interleukins- 16
7 days
Immune responseMonocyte phenotype - Interleukins- 17
7 days
Immune responseMonocyte phenotype - Interleukins- 23
7 days
Immune responseImmunomodulatory factor -Transforming growth factor-β
7 days
Immunomodulatory factor - Interleukins -4
7 days
Immune responseImmunomodulatory factor - Interleukins - 10
7 days
Immune responseRelative proportions of WBC subsets
7 days
Other measures (2)
Monocyte phenotype - 'omic analyses
7 days
Neurofilament
7 days
Blood or spinal fluid markers
Who could take part
Progressive MS · 35 to 65
Show the full criteria
Inclusion criteria
1. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. 2. Aged 35-65 years old 3. A female subject is eligible to participate if she is a) of non-childbearing potential, defined as pre-menopausal females with a documented tubal ligation or hysterectomy, or postmenopausal defined as 12 months of spontaneous amenorrhea or b) of childbearing potential but not pregnant (as determined by urinary pregnancy test on screening and on each study day) and willing to use one of the contraception methods listed below 4. Male subject must agree to use one of the contraception methods listed above. 5. Willing to abstain from alcohol for the duration of dosing. 6. Expanded Disability Status Scale (EDSS) >3.5 \<6.5 (SPMS patients only)
Exclusion criteria
1. History of active neurological disease other than migraine or MS 2. Clinically meaningful abnormalities in routine bloods including: * eGFR \< 60ml/min * Elevation of liver enzymes/bilirubin * Prolonged prothrombin time * Thrombocytopenia 3. Use of the following medications or therapies: * Immunosuppressive or immunomodulatory drugs within the last 6 months * Alemtuzumab or haematopeotic stem cell therapy * Central nervous system depressants (including opioid analgesics, barbiturates, sleeping pills, antihistamines, antipsychotics) * P450 CY3A4 inducers or inhibitors * oral contraceptives * oral anticoagulants or antiplatelet agents other than low dose aspirin * levothyroxine 4. Currently breastfeeding 5. Any clinical significant medical conditions that in the opinion of the investigator would compromise subjects' safety or compliance with study procedures. 6. History of any clinical condition which in the opinion of the principal investigator would compromise the scientific integrity of the study, such as some chronic systemic diseases affecting blood, liver or kidneys or endocrine system 7. Unwillingness or inability to follow the procedures outlined in the protocol 8. Subject is mentally or legally incapacitated 9. Contraindication to XBD173 use: • Hypersensitivity to the active substance or to any of the excipients 10. Contraindication to etifoxine use: * Myasthenia gravis * syndromes of glucose and galactose malabsorption or lactose deficiency
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
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History
- Status changed from Recruiting to Status unknown
- Result signal changed from Ongoing to Status unknown
Started
Jan 2018
Main results due
Jan 2025
Finished
Jan 2025