Status:
COMPLETED
Amiloride Clinical Trial In Optic Neuritis
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Multiple Sclerosis Society of Great Britain and Northern Ireland
Conditions:
Optic Neuritis
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief 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 testi...
Detailed Description
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. In addition to the inflammatory episodes...
Eligibility Criteria
Inclusion
- 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;
- Not had a previous episode of optic neuritis,
- A duration of disease of ≤10 years
- An EDSS (Expanded Disability Status Scale) of ≤3.
- 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
- 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.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01802489
Start Date
February 1 2013
End Date
November 1 2015
Last Update
May 17 2018
Active Locations (1)
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1
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU