At a glance
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OxCarbazepine as a Neuroprotective Agent in MS: A Phase 2a Trial
In Brief
A Phase 2 clinical trial evaluating Oxcarbazepine and Placebo for Multiple Sclerosis. Completed, enrolled 30 participants across 1 site.
Detailed 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 it is now possible to 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. The investigators will 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.
Study Details
Timeline
Interventions
Oxcarbazepine 150mg tablet, over encapsulated and back-filled with Microcrystalline Cellulose/Magnesium Stearate 1%.
Placebo in a matched capsule containing Microcrystalline Cellulose/Magnesium Stearate 1%.