Protective Role of Oxcarbazepine in Multiple Sclerosis

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.

Conditions

• Multiple Sclerosis

Interventions

DRUG

Oxcarbazepine

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

DRUG

Placebo

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

Sponsors & Collaborators

• National Multiple Sclerosis Society

  collaborator OTHER

• Novartis Pharmaceuticals

  collaborator INDUSTRY

• Barts & The London NHS Trust

  collaborator OTHER

• University College, London

  collaborator OTHER

• Royal Free Hospital NHS Foundation Trust

  collaborator OTHER

• Mid and South Essex NHS Foundation Trust

  collaborator OTHER

• St George's Healthcare NHS Trust

  collaborator OTHER

• Barnet and Chase Farm Hospitals NHS Trust

  collaborator OTHER

• Queen Mary University of London

  lead OTHER

Principal Investigators

• Gavin Givannoni · Queen Mary University of London

• Monica Calado Marta · Barts & The London NHS Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-31

Primary Completion

2018-01-31

Completion

2018-01-31

Countries

• United Kingdom

Study Locations