Optic neuritis is among the most common first symptoms of multiple sclerosis leading to significant atrophy of the optic nerve within a short period of time, thus reflecting neurodegneration.
Conditions
Interventions
Trade Name: Amilostad HCT
Product Name: Amilostad HCT tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: AMILORIDE HYDROCHLORIDE, 2 H2O
Other descriptive name: Amiloride Hydrochloride
Concentra
Sponsors
Universitätsklinik für Neurologie, Medizinische Universität Wien
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients between 18 and 50 years of age with a first episode of ON and a visual acuity decreased to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Known allergy or hypersensitivity to amilostad HCT or any of its ingrediens •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 amilorid 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary objectives are to assess the efficacy of amiloride HCT in improving latencies of visual evoked potentials and its effect on different ophthalmologic parameters (visual acuity, low contrast visual acuity, color vision, visual fields) and MRI parameters (T2 lesions, Gadolinium enhancing lesions, black holes, lesion volume of the optiv nerve region).;Primary end point(s): The question of wether change in retinal nerve fiber layer thickness (reflecting optical nerve atrophy) as measured by OCT is less prominent after 24 weeks of amiioride HCT treatment as compard to the placebo group comprises the primary objective of our study. ;Timepoint(s) of evaluation of this end point: Baseline, after 8, 12 and 24 weeks;Main Objective: The goal of our study is to determine the efficacy of amiloride hydrochlorthiazide in exerting a neuroprotective role in patients with acute autoimmune optic neuritis (i.e. reducing optic nerve atrophy) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The question of wether change in retinal ganglion cell layer as measured by optical coherence tomography is less prominent after 24 weeks of amiloride HCT treatment as compared to the placebo group comprises one of the secondary objectives of our study. Furthermore, secondary objectives are to assess the effect of amiloride hydrochlorothiazide treatment on VEP-latency, visual acuity, low contrast visual acuity, color vision, visual fields and several MRI-parameters with special attention to the optic nerve region (T2 lesions, Gadolinium enhancing lesions, black holes, lesion volume of the optiv nerve region).;Timepoint(s) of evaluation of this end point: Except for MRI, all assessments will be done at baseline, after 8, 12 and 24 weeks. MRI will be done at baseline and after 24 weeks. | — |
Countries
Austria
Contacts
Public ContactInformationsstelle
Wiener Pflege-,Patientinnen-und Patientenanwaltschaft
Outcome results
None listed