CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Oxcarbazepine +1 moredrug
Likely dose
Oxcarbazepine 150mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02104661
NCT02104661Phase 2Completed

OxCarbazepine as a Neuroprotective Agent in MS: A Phase 2a Trial

Queen Mary University of London·interventional·Posted Apr 4, 2014·Updated Apr 18, 2018

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

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 4, 2014
Enrollment StartOct 1, 2014
Primary CompletionJan 31, 2018
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 12.2 years ago

Interventions

Oxcarbazepinedrug

Oxcarbazepine 150mg tablet, over encapsulated and back-filled with Microcrystalline Cellulose/Magnesium Stearate 1%.

Placebodrug

Placebo in a matched capsule containing Microcrystalline Cellulose/Magnesium Stearate 1%.