The Amiloride Clinical Trial in Optic Neuritis - does amiloride protect nerve cells from injury after an episode of optic nerve inflammation?

Phase 1

• Conditions: Optic Neuritis; MedDRA version: 14.1 Level: PT Classification code 10030942 Term: Optic neuritis System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-004980-39-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-22
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 46

Inclusion Criteria

• Patients with a first episode of unilateral ON • 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 ON, A duration of disease of = 10 years An EDSS (Expanded Disability Status Scale) of =3. No immune modulating treatment other than ß-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. • Female participants of child bearing potential must be willing to use two effective methods of contraception (barrier methods, hormonal methods or abstinence) during the initial 5 month treatment period of the study and for one month thereafter. • 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 46
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

• Previous diagnosis of ON • Any concomitant immune suppressing or immune modulating therapy excluding ß-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified