Amiloride Clinical Trial in Optic Neuritis Version 1.0

• Research type

  Research Study

• Full title

  A double blind randomised controlled trial on neuroprotection of amiloride in optic neuritis

• IRAS ID

  115145

• Contact name

  Matthew Craner

• Sponsor organisation

  University of Oxford

• Eudract number

  2012-004980-39

• ISRCTN Number

  n/a

• Research summary

  Multiple sclerosis (MS), an inflammatory condition of the nervous system, is the most common cause of disability in people of working age in the western world. MS can cause loss of nerve cells, and this loss of nerve cells is closely linked to the amount of disability caused by MS. Optic neuritis (ON) is a common event in MS, and causes significant loss of nerve cells in the eye, resulting in poor vision. ON also provides a sensitive way of testing the effectiveness of drugs that may help protect from loss of nerve cells in ON and therefore in MS.We have identified through laboratory and early clinical research in humans that amiloride (a water tablet already used in the UK) may be a drug that can be of benefit in ON by protecting from loss of nerves cells (a neuroprotective drug). We propose a combination of simple eye scanning techniques along with magnetic resonance imaging of the brain and measures of visual function to determine if amiloride is effective as a neuroprotective drug. This will be a randomised control trial, funded by the MS society, for people with their first episode of optic neuritis, with or without a previous diagnosis of MS. Participants will receive either amiloride or an identical placebo tablet for 5 months, followed 4 times over a total of 12 months. The study is being conducted in the John Radcliffe hospital in Oxford but will also be recruiting patients from Stoke Mandeville hospital, Frimley park hospital, Royal Berkshire Hospital (Reading) and King Edward VII Hospital (Windsor).Should this trial show a significant benefit from amiloride in ON, it will be an important first step in developing neuroprotective therapies in ON and MS and potentially this could have a significant impact on people with MS and their carers.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  13/SC/0022

• Date of REC Opinion

  21 Jan 2013

• REC opinion

  Further Information Favourable Opinion