Amiloride Hydrochlorothiazide as Treatment of Acute Inflammation of the Optic Nerve

This study is not yet open for participant recruitment.
Verified June 2013 by Medical University of Vienna
Information provided by (Responsible Party):
Prof. Fritz Leutmezer, Medical University of Vienna Identifier:
First received: June 13, 2013
Last updated: NA
Last verified: June 2013
History: No changes posted

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.

Condition Intervention Phase
Acute Autoimmune Optic Neuritis
Drug: Amiloride hydrochlorothiazide
Drug: Sugar pill
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Double-Blind, Phase IIa Study of Amiloride in the Treatment of Acute Autoimmune Optic Neuritis

Resource links provided by NLM:

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Change in thickness of retinal nerve fiber layer (RNFL) [ Time Frame: Baseline versus follow-up at 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 78
Study Start Date: September 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Amiloride hydrochlorothiazide Drug: Amiloride hydrochlorothiazide
Blinding will be done by over-encapsulating amiloride HCT tablets and providing corresponding placebo capsules.Patients will be provided with capsules (size 00) containing one tablet of study medication (Amilostad HCT 5/50mg tablet or placebo) and instructed to take these capsules once daily in the morning together with breakfast. Visit 2 will be scheduled one week after baseline and at visit 2 patients will be provided with capsules containing two tablets of study medication. This maintenance dose will not be changed throughout the remaining study period. Placebo will be administered in the exact same manner.
Other Names:
  • Marketing Authorisation number: 1-22734
  • Trade name: Amilostad HCT
Placebo Comparator: Sugar pill Drug: Sugar pill


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT01879527

Contact: Fritz Leutmezer, MD +43140400 ext 3120

Medical University of Vienna, Department of Neurology Not yet recruiting
Vienna, Austria, 1090
Contact: Fritz Leutmezer, MD    +43140400 ext 3120   
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided

Responsible Party: Prof. Fritz Leutmezer, MD, Medical University of Vienna Identifier: NCT01879527     History of Changes
Other Study ID Numbers: SSP-2, 2012-005113-39
Study First Received: June 13, 2013
Last Updated: June 13, 2013
Health Authority: Austria: Austrian Federal Office for Safety in Health Care

Additional relevant MeSH terms:
Optic Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
Amiloride, hydrochlorothiazide drug combination
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Antihypertensive Agents processed this record on April 16, 2014