Status:
UNKNOWN
Amiloride Hydrochlorothiazide as Treatment of Acute Inflammation of the Optic Nerve
Lead Sponsor:
Medical University of Vienna
Conditions:
Optic; Neuritis, With Demyelination
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief 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 s...
Detailed Description
Recent studies have shown that the acid-sensing ion channel 1 (ASIC1) contributes to the axonal degeneration in CNS lesions Physiologically, ASIC1 has been described as a postsynaptic proton receptor ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2016
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT01879527
Start Date
March 1 2014
End Date
April 1 2016
Last Update
May 12 2015
Active Locations (1)
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1
Medical University of Vienna, Department of Neurology
Vienna, Vienna, Austria, 1090