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New treatment option for Multiple Sclerosis
Official title Validation of the 18 kiloDalton Translocator Protein (TSPO) as a Novel Neuroimmunodulatory Target
ClinicalTrials.gov ID: NCT03850301
What this study is testing
What is XBD173?
XBD173 is an investigational medicine, being studied as a potential treatment for multiple sclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Aged 35-65 years old
- A female subject is eligible to participate if she is a) of non-childbearing potential, defined as pre-menopausal females with a documented tubal...
- Male subject must agree to use one of the contraception methods listed above.
- Willing to abstain from alcohol for the duration of dosing.
You likely can't join if
- History of active neurological disease other than migraine or MS
- Clinically meaningful abnormalities in routine bloods including:
- eGFR \< 60ml/min
- Elevation of liver enzymes/bilirubin
- Prolonged prothrombin time
- Thrombocytopenia
See the full eligibility criteria
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Aged 35-65 years old
- 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...
- Male subject must agree to use one of the contraception methods listed above.
- Willing to abstain from alcohol for the duration of dosing.
- Expanded Disability Status Scale (EDSS) \>3.5 \<6.5 (SPMS patients only)
- History of active neurological disease other than migraine or MS
- Clinically meaningful abnormalities in routine bloods including:
- eGFR \< 60ml/min
- Elevation of liver enzymes/bilirubin
- Prolonged prothrombin time
- Thrombocytopenia
- 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
- Currently breastfeeding
- Any clinical significant medical conditions that in the opinion of the investigator would compromise people' safety or compliance with study procedures.
- 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...
- Unwillingness or inability to follow the procedures outlined in the protocol
- Subject is mentally or legally incapacitated
- Contraindication to XBD173 use:
- Hypersensitivity to the active substance or to any of the excipients
- Contraindication to etifoxine use:
- Myasthenia gravis
- syndromes of glucose and galactose malabsorption or lactose deficiency
The study team makes the final eligibility decision.
Where it's taking place
- London, England, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 35 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, England, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.