Amiloride Clinical Trial in Optic Neuritis

Phase 2

Completed

• Conditions: Topic: Eye, Neurological; Subtopic: Eye (all Subtopics), Neurological (all Subtopics); Disease: Ophthalmology, Nervous system disorders; Eye Diseases; Optic Neuritis

• Registration Number: ISRCTN99153976
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-03
• Last Update Posted: 6 February 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1. Patients with a first episode of unilateral ON
2. 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
3. A duration of disease of = 10 years
4. An EDSS (Expanded Disability Status Scale) of =3
5. No immune modulating treatment other than ß-Interferon or Glatiramer Acetate at time of recruitment
6. Able to be randomised within 28 days of onset of visual symptoms
7. Visual acuity of =6/9
8. Participant is willing and able to give informed consent for participation in the study and able to comply with study visits
9. Male or Female, aged between 18 ? 55 years.
10. Stable dose of current regular medication for at least 4 weeks prior to study entry
11. 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.
12. Participant has clinically acceptable urea and electrolytes and estimated glomerular filtration rate (eGFR) >60
13. Able and willing to comply with all study requirements.
14. Willing to allow his or her General Practitioner to be notified of participation in the study.

Exclusion Criteria

1. Previous diagnosis of ON
2. Any concomitant immune suppressing or immune modulating therapy excluding ß-interferon or glatiramer acetate.
3. Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
4. Concomitant potassium supplements, angiotensin converting enzyme inhibitors, angiotensin II antagonists, cyclosporine, tacrolimus or lithium
5. Any contra-indication to MRI ? severe claustrophobia, metal implant, pacemaker, etc.
6. Participant who is terminally ill or is inappropriate for placebo medication
7. Impaired renal function : eGFR =60, anuria, acute or chronic renal insufficiency and evidence of diabetic nephropathy
8. Raised serum potassium (K+ >5.5mmol/l)
9. Diabetes
10. Significant concomitant eye disease in either eye that may affect diseased or fellow eye results.
11. 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.
12. Participants who have participated in another research study involving an investigational product in the past 12 weeks.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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