PROXIMUS - PRotective role of OXcabazepine In MUltiple Sclerosis
Research type
Research Study
Full title
Oxcarbazepine as a neuroprotective agent in MS: phase 2a trial
IRAS ID
139791
Contact name
Sally Burtles
Contact email
Eudract number
2013-002419-87
Duration of Study in the UK
1 years, 9 months, 29 days
Research summary
People with multiple sclerosis (MS) have nerve loss even without acute inflammatory relapses, as obvious in the progressive phase of disease. Drugs that may prevent nerve loss work better in earlier stages when it is difficult to measure progressive disability. But we can now measure the nerve loss as neurofilament light (NFL) in the cerebrospinal fluid (CSF). This is a trial of a neuroprotective drug, oxcarbazepine, which showed benefit in an animal model of multiple sclerosis. We use an innovative outcome, a reduction in the content of NFL in the CSF, as well as the usual clinical disability and imaging methods, to measure the success of the oxcarbazepine as a neuroprotective agent in MS. The use of NFL, a surrogate marker of neurodegeneration, allows a blinded and accurate outcome measure at much earlier stage than it is possible with clinical measures.
REC name
London - Harrow Research Ethics Committee
REC reference
14/LO/0185
Date of REC Opinion
18 Mar 2014
REC opinion
Further Information Favourable Opinion