Amiloride Hydrochlorothiazide as Treatment of Acute Inflammation of the Optic Nerve

• Status: Unknown status
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Following acute inflammation of the optic nerve region, as commonly seen in multiple sclerosis patients, the optic nerve often undergoes atrophy, thus representing permanent damage. Data from animal studies suggest that amiloride may prevent this process. The aim of this study is to assess a potential neuroprotective effect of amiloride in acute autoimmune inflammation of the optic nerve region.

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

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Amiloride; Amiloride, hydrochlorothiazide drug combination; Hydrochlorothiazide

Criteria

Inclusion Criteria:

Patients between 18 and 50 years of age with a first episode of optic neuritis (ON) and a visual acuity decreased to <0,6 will be eligible for inclusion in the study. Diagnosis of ON has to be confirmed by an ophthalmologist. Onset of symptoms has to be within 10 days prior to inclusion into the study

Exclusion Criteria:

• Known allergy or hypersensitivity to amilostad HCT or any of its ingredients

• Known allergy or hypersensitivity to other sulphonamide-derived drugs

• Impaired renal function or any known renal disease

• Intake of other potassium-conserving diuretics

• Intake of potassium supplements or a special potassium rich diet

• Intake of spironolactone or triamterene

• Moderate to severe hepatic failure

• Morbus Addison

• Known hypercalcaemia

• Intake of lithium therapy

• Blood urea > 10mmol/l

• Diabetes mellitus

• History of ON or any other ocular disease (affected as well as unaffected eye)

• Pregnancy or lactation period

• Treatment with corticosteroids or amiloride within 30 days prior to the inclusion into the study

• Use of any immunomodulatory or immunosuppressive agents anytime in the past

• Dearrangement of serum sodium or potassium levels on the lab