Amiloride Clinical Trial In Optic Neuritis

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Collaborator: Multiple Sclerosis Society of Great Britain and Northern Ireland
• Treatments: Amiloride

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.