Status:
TERMINATED
[18F]PBR111 and Microglial Activation in Multiple Sclerosis
Lead Sponsor:
GlaxoSmithKline
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
20-70 years
Phase:
PHASE2
Brief Summary
This is a study aimed to characterize \[18F\]PBR111 as an in vivo marker of microglial activation in Multiple Sclerosis. Regional binding of \[18F\]PBR111 will be quantified with PET in the brain of u...
Detailed Description
Multiple Sclerosis is characterized by brain areas of focal neuroinflammation. Imaging of microglia activation in multiple sclerosis could represent a useful marker of neuroinflammation. A novel PET t...
Eligibility Criteria
Inclusion
- Male or Female, aged 20-70
- Able to read, comprehend and record information written in English.
- Capable of giving written informed consent
- Provide a venous blood sample that will be used for genetics research and the in vitro ligand binding assay.
- A female subject is eligible to participate if she is willing to follow contraception guidelines or if she is of non-childbearing potential.
- Male subjects must agree to use one of the contraception methods
- MS subjects:
- Clinical or clinical and laboratory supported diagnosis of multiple sclerosis
- EDSS score up to and including 7.5 at screening evaluation
- Healthy Volunteers:
- 1\. Healthy control subjects defined as free from clinically significant active disease as assessed by the Principal Investigator from their medical and psychiatric past and present history
- \-
Exclusion
- If female, positive urine pregnancy test
- An estimated glomerular filtration rate (eGFR) of less than 60 ml/kg/1.73m2
- History or presence of a neurological diagnosis
- Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with radiation exposure.
- Family history of cancer (one or more first-degree relative diagnosed before the age of 55).
- Subject or caregiver is an immediate family member or employee of the participating Investigator, any of the participating site staff or GSK staff.
- Any subject the investigator deems unsuitable for the study (e.g., due to either medical reasons, laboratory abnormalities or subject's unwillingness to comply with all study-related procedures).
- Contraindications to MRI scanning
- Any physical abnormality or functional disability which prevents the subject from acquiring a suitable position for scanning.
- History of or suffers from claustrophobia or feels that he will be unable to lie still on his back in the PET camera or MRI scanner for a period of at least 90mins.
- Unwillingness or inability to follow the procedures outlined in the protocol. -
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01428505
Start Date
July 1 2011
End Date
March 1 2013
Last Update
February 8 2016
Active Locations (1)
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1
GSK Investigational Site
London, London, United Kingdom, W12 0NN