drugset / Trial / NCT01802489
Amiloride Clinical Trial In Optic Neuritis
Phase 2
Completed
46 enrolled
University of Oxford
Multiple Sclerosis Society of Great Britain and Northern Ireland · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Optic neuritis (ON) is a common event in Multiple Sclerosis (MS), and causes significant loss of nerve cells in the eye, resulting in poor vision. Optic neuritis 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. The investigators have identified through laboratory and early clinical research in humans that amiloride (a water tablet already in use) may be a drug that can be of benefit in optic neuritis by protecting from loss of nerves cells, ie a neuroprotective drug. The purpose of this study is to assess the efficacy of amiloride as a neuroprotective drug in optic neuritis
Timeline
- Start
- 2013-02
- Primary completion
- 2015-11
- Completion
- 2015-11
Publications
- McKee JB, Cottriall CL, Elston J, Epps S, Evangelou N, Gerry S, Kennard C, Kong Y, Koelewyn A, Kueker W, Leite MI, Palace J, Craner M. Amiloride does not protect retinal nerve fibre layer thickness in optic neuritis in a phase 2 randomised controlled trial. Mult Scler. 2019 Feb;25(2):246-255. doi: 10.1177/1352458517742979. Epub 2017 Nov 27.
- McKee JB, Elston J, Evangelou N, Gerry S, Fugger L, Kennard C, Kong Y, Palace J, Craner M. Amiloride Clinical Trial In Optic Neuritis (ACTION) protocol: a randomised, double blind, placebo controlled trial. BMJ Open. 2015 Nov 9;5(11):e009200. doi: 10.1136/bmjopen-2015-009200.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amiloride | Small molecule | 10 mg | — |