Actively Recruiting
Validation of the 18 kiloDalton Translocator Protein (TSPO) as a Novel Neuroimmunodulatory Target
Led by Imperial College London · Updated on 2024-10-15
44
Participants Needed
1
Research Sites
369 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Validation of the 18 kiloDalton Translocator Protein (TSPO) as a Novel Neuroimmunodulatory Target
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give written informed consent
- Aged between 35 and 65 years old
- Females must be either of non-childbearing potential or use approved contraception if of childbearing potential
- Males must agree to use approved contraception
- Willing to abstain from alcohol during dosing
- Expanded Disability Status Scale (EDSS) score greater than 3.5 and less than 6.5 (SPMS patients only)
You will not qualify if you...
- History of active neurological diseases other than migraine or MS
- Blood abnormalities, including low eGFR, elevated liver enzymes/bilirubin, prolonged prothrombin time, or thrombocytopenia
- Use of immunosuppressive or immunomodulatory drugs within the last 6 months
- Prior treatment with alemtuzumab or stem cell therapy
- Use of central nervous system depressants, P450 CY3A4 inducers/inhibitors, oral contraceptives, oral anticoagulants (except low dose aspirin), or levothyroxine
- Currently breastfeeding
- Any medical condition that compromises safety or study compliance
- Any clinical condition threatening the scientific integrity of the study
- Unwillingness or inability to follow study procedures
- Mentally or legally incapacitated
- Hypersensitivity to XBD173 or its ingredients
- Contraindications to etifoxine including myasthenia gravis or certain sugar metabolism disorders
AI-Screening
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Trial Site Locations
Total: 1 location
1
Imperial College Healthcare NHS Trust
London, England, United Kingdom, W12 0NN
Actively Recruiting
Research Team
D
David Owen, PhD
CONTACT
L
Lina Aimola, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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