Amiloride Clinical Trial In Optic Neuritis

A Double Blind Randomised Control Trial on Neuroprotection of Amiloride in Optic Neuritis

CompletedPhase 2Relapsing MSNCT018024892012-004980-39ISRCTN99153976

What it found

Missed its main goal

The main measure did not show a significant benefit.

“No significant differences were found in GDx ( p = 0.840).”
Read by software from the paper's abstract

Scanning laser polarimetry (GDx) at 6 months · 6 months

p = 0.840

Total participants: 48

Read by software from the paper's abstract

What was tested

Treatment tested

  • Amiloride

Placebo

  • Placebo

What it measured

Main measures

  • Scanning laser polarimetry determined retinal nerve fibre layer thickness

    Baseline, 6 and 12 months

    Retina scans (OCT)

  • Scanning laser polarimetry (GDx) determined difference in retinal nerve fibre layer (RNFL) thickness at 6 months between affected eye and non-affected fellow eye at baseline between the amiloride and placebo group

    Retina scans (OCT)

  • Scanning Laser Polarimetry determined retinal fibre layer thickness measured at baseline, 6 and 12 months.

Other measures (7)

  • Optical coherence tomography determined difference in retinal nerve fibre layer thickness.

    Baseline, 6 and 12 months

    Retina scans (OCT)

  • Differences between the amiloride and placebo groups in non-conventional MRI surrogate marker of white matter and grey matter injury and connectivity by 3T scanning.

    Baseline, 6 and 12 months

    MRI lesionsBrain volume lossMyelin repairNerve conduction tests

  • Visual Function

    Baseline, 6 and 12 months

    Vision

  • Visual Electrophysiology

    0 and 6 months

    Myelin repairVision

  • Quality of life questionnaires

    Baseline, 6 and 12 months

    VisionQuality of life (reported by participants)

  • a) Optical Coherence Tomography (OCT) determined difference in RNFL thickness at 6 months and 12 between affected eye and non-affected fellow eye at baseline between the amiloride and placebo group b) GDX difference in RNFL thickness at 126 months between affected eye and non-affected fellow eye at baseline between the amiloride and placebo group c) Differences between the amiloride and placebo

    MRI lesionsMyelin repairRetina scans (OCT)VisionQuality of life (reported by participants)

  • 1. Colour Vision measured at baseline, and 6 months 2. Non-conventional surrogate marker of white matter and grey matter injury and connectivity by 3T MRI measured at baseline, 6 and 12 months 3. Optical Coherence Tomography - determined difference in retinal nerve fibre layer thickness measured at baseline, 6 and 12 months 4. Quality of Life Questionnaires measured at baseline, 6 and 12 months 5.

    MRI lesionsRetina scans (OCT)VisionNerve conduction testsQuality of life (reported by participants)

Who could take part

Relapsing MS · 18 to 55

Show the full criteria

Inclusion criteria

* Participants with a first episode of unilateral optic neuritis * Participants with an existing diagnosis of relapsing remitting MS and new onset of ON are eligible if they have; 1. Not had a previous episode of optic neuritis, 2. A duration of disease of ≤10 years 3. An EDSS (Expanded Disability Status Scale) of ≤3. 4. No immune modulating treatment other than β-Interferon or glatiramer acetate at time of recruitment * Able to be randomised within 28 days of onset of visual symptoms * Visual acuity of ≤6/9 * Participant is willing and able to give informed consent for participation in the study and able to comply with study visits * Male or Female, aged between18 - 55 years. * Stable dose of current regular medication for at least 4 weeks prior to study entry. * Participant has clinically acceptable urea and electrolytes and estimated glomerular filtration rate (eGFR) >60 * Able and willing to comply with all study requirements. * Willing to allow his or her General Practitioner to be notified of participation in the study.

Exclusion criteria

* Previous diagnosis of optic neuritis * Any concomitant immune suppressing or immune modulating therapy excluding β-interferon or glatiramer acetate. * Female participants who are pregnant, lactating or planning pregnancy during the course of the study. * Concomitant potassium supplements, angiotensin converting enzyme inhibitors, angiotensin II antagonists, cyclosporine, tacrolimus or lithium * Any contra-indication to MRI - severe claustrophobia, metal implant, pacemaker, etc. * Participant who is terminally ill or is inappropriate for placebo medication * Impaired renal function : eGFR ≤60, anuria, acute or chronic renal insufficiency and evidence of diabetic nephropathy * Raised serum potassium (K+ >5.5mmol/l) * Diabetes * Significant concomitant eye disease in either eye that may affect diseased or fellow eye results. * Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. * Participants who have participated in another research study involving an investigational product in the past 12 weeks.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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

Papers

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History

    1. Started

      Feb 2013

    2. Main results due

      Nov 2015

    3. Finished

      Nov 2015

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