NCT01879527

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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2013

Completed
9 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 12, 2015

Status Verified

May 1, 2015

Enrollment Period

2.1 years

First QC Date

June 13, 2013

Last Update Submit

May 8, 2015

Conditions

Optic; Neuritis, With Demyelination

Outcome Measures

Primary Outcomes (1)

  • Change in thickness of retinal nerve fiber layer (RNFL)

    Baseline versus follow-up at 24 weeks

Study Arms (2)

Amiloride hydrochlorothiazide

ACTIVE COMPARATOR

5,68 mg Amiloridhydrochloride 2H20 (analogue 4,32 mg Amilorid) und 50 mg Hydrochlorothiazid. Trade name of the agent: Amilostad HCT 5/50mg tablets Manufacturer: Stada initial dose: 1 x 5/50mg once daily target dose: 2 x 5/50mg once daily Patients will be provided with capsules (size 00) containing one tablet of study medication 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

Drug: Amiloride hydrochlorothiazide

Sugar pill

PLACEBO COMPARATOR

Patients will be provided with capsules (size 00) containing sugar and instructed to take these capsules once daily in the morning together with breakfast.

Drug: Sugar pill

Interventions

Amiloride hydrochlorothiazideDRUG

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.

Also known as: Marketing Authorisation number: 1-22734, Trade name: Amilostad HCT
Amiloride hydrochlorothiazide
Sugar pillDRUG

containing placebo

Also known as: placebo
Sugar pill

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • 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
  • Use of any immunomodulatory or immunosuppressive agents anytime in the past
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Department of Neurology

Vienna, Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Neuritis

Interventions

amiloride, hydrochlorothiazide drug combinationSugars

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

  • Fritz Leutmezer, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fritz Leutmezer, MD

CONTACT

+43140400fritz.leutmezer@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 13, 2013

First Posted

June 18, 2013

Study Start

March 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 12, 2015

Record last verified: 2015-05

Locations

AU(1)