Amiloride Hydrochlorothiazide as Treatment of Acute Inflammation of the Optic Nerve.

• Register: EUCTR
• Last refreshed on: 22 April 2013
• Main ID: EUCTR2012-005113-39-AT
• Date of registration: 18/02/2013
• Prospective Registration: Yes
• Primary sponsor: Universitätsklinik für Neurologie, Medizinische Universität Wien
• Public title: Amiloride Hydrochlorothiazide as Treatment of Acute Inflammation of the Optic Nerve.
• Scientific title: A Randomized, Placebo-Controlled, Double-Blind, Phase IIa Study of Amiloride in the Treatment of Acute Autoimmune Optic Neuritis - Amiloride Hydrochlorothiazide in acute autoimmune optic neuritis
• Date of first enrolment: 08/04/2013
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005113-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Austria

Contacts

• Name: Informationsstelle
• Affiliation: Wiener Pflege-,Patientinnen-und Patientenanwaltschaft

• Name: Informationsstelle
• Affiliation: Wiener Pflege-,Patientinnen-und Patientenanwaltschaft

Key inclusion & exclusion criteria

Inclusion criteria:
Patients between 18 and 50 years of age with a first episode of 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 ophtalmologist. Onset of symptoms has to be within 10 days prior to inclusion into the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 78
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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.

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

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
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5.68-
INN or Proposed INN: hydrochlorothiazide
Other descriptive name: HYDROCHLOROTHIAZIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)

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 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).

Secondary Outcome(s)

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.

Secondary ID(s)

SSP-2

Source(s) of Monetary Support

Universitätsklinik für Neurologie, Medizinische Universität Wien