Amiloride Hydrochlorothiazide as Treatment of Acute Inflammation of th
A Randomized, Placebo-Controlled, Double-Blind, Phase IIa Study of Amiloride in the Treatment of Acute Autoimmune Optic Neuritis
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Amiloride hydrochlorothiazide
- Amiloride
Placebo
- Sugar pill
What it measured
Main measures
Change in thickness of retinal nerve fiber layer (RNFL)
Baseline versus follow-up at 24 weeks
Retina scans (OCT)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.
Brain volume lossRetina scans (OCT)
Other measures (1)
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
MRI lesionsMyelin repairRetina scans (OCT)VisionThinking and memory
Who could take part
MS (type not specified) · 18 to 50
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Mar 2014
Main results due
Apr 2016
Finished
Apr 2016