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    Summary
    EudraCT Number:2012-005113-39
    Sponsor's Protocol Code Number:SSP-2
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-02-18
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2012-005113-39
    A.3Full title of the trial
    A Randomized, Placebo-Controlled, Double-Blind, Phase IIa Study of Amiloride in the Treatment of Acute Autoimmune Optic Neuritis
    Amilorid Hydrochlorothiazid bei akuter, autoimmun-vermittelter Optikusneuritis. Eine randomisierte, placebo-kontrollierte, doppel-blinde, Phase IIa Studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Amiloride Hydrochlorothiazide as Treatment of Acute Inflammation of the Optic Nerve.
    Amilorid Hydrochlorothiazid als Therapie bei akuter Sehnerventzündung.
    A.3.2Name or abbreviated title of the trial where available
    Amiloride Hydrochlorothiazide in acute autoimmune optic neuritis
    Amilorid Hydrochlorothiazid bei akuter autoimmun-vermittelter Optikusneuritis
    A.4.1Sponsor's protocol code numberSSP-2
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversitätsklinik für Neurologie, Medizinische Universität Wien
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUniversitätsklinik für Neurologie, Medizinische Universität Wien
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWiener Pflege-,Patientinnen-und Patientenanwaltschaft
    B.5.2Functional name of contact pointInformationsstelle
    B.5.3 Address:
    B.5.3.1Street AddressSchönbrunner Strasse 108, Eingang Sterkgasse
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1050
    B.5.3.4CountryAustria
    B.5.4Telephone number+43 1587 12 04
    B.5.5Fax number+431586 36 99
    B.5.6E-mailpost@wpa.wien.gv.at
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Amilostad HCT
    D.2.1.1.2Name of the Marketing Authorisation holderStada Arzneimittel, Wien
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAmilostad HCT tablets
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMILORIDE HYDROCHLORIDE, 2 H2O
    D.3.9.3Other descriptive nameAmiloride Hydrochloride
    D.3.9.4EV Substance CodeSUB30034
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.68
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNhydrochlorothiazide
    D.3.9.3Other descriptive nameHYDROCHLOROTHIAZIDE
    D.3.9.4EV Substance CodeSUB08062MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    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.
    Die Optikusneuritis tritt häufig als Erstmanifestation von Multipler Sklerose auf und führt als Ausdruck der Neurodegeneration relativ rasch zu einer Atrophie des N. opticus.
    E.1.1.1Medical condition in easily understood language
    Acute inflammation of the optic nerve is among the most common first symptoms of multiple sclerosis leading to loss of optic nerve tissue.
    Die akute Sehnerventzündung triff häufig als Erstsymptom bei Multipler Sklerose auf und führt relativ rasch zum Abbau von Sehnervengewebe.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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)
    Die Studie soll untersuchen, ob bei eine Behandlung mit Amilorid HCT bei akuter Optikusneuritis neuroprotektiv wirkt, also ob das Ausmass der Atrophie nach Optikusneuritis verringert werden kann.
    E.2.2Secondary objectives of the trial
    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).
    Die Studie soll weiters untersuchen, ob sich eine Behandlung mit Amilorid HCT auf die Latenzen der visuell evozierten Potentiale auswirkt sowie auf verschiedene ophthalmologische (Sehschärfe, Niedrig Kontrast Sehschärfe, Farbsehen, Gesichtsfeld) und MR-Parameter (
    T2 Läsionen, Kontrastmittelspeichernde Läsionen, black holes, Läsionsvolumen des N. opticus)
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    Alter zwischen 18-50 Jahre, erstmalige Optikusneuritis mit Visus <0.6 am betroffenen Auge, Diagnose einer Optikusneuritis muss augenärztlich bestätigt sein, Beginn der Symptome innerhalb von 10 Tagen vor Studieneinschluss.
    E.4Principal 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
    •Bekannte Allergie oder Unverträglichkeit von Amilostad HCT Tabletten oder einem der Bestandteile
    •Bekannte Allergie oder Unverträglichkeit von Sulphonamiden
    •Eingeschränkte Nierenfunktion oder jegliche bekannte Nierenerkrankung
    •Einnahme anderer Kalium sparender Diuretika
    •Einnahme von Kalium-Nahrungsergänzungsmittel oder eine spezielle Kalium reiche Diät
    •Einnahme von Spironolacton oder Triamteren
    •Moderate bis schwere Leberfunktionsstörung
    •Morbus Addison
    •Bekannte Hypercalcämie
    •Einnahme von Lithium
    •Blut Harnstoff >10mmol/l
    •Bekannter Diabetes mellitus
    •anamnestisch bereits durchgemachte Optikusneuritis oder jegliche andere Augenerkrankung sowohl am betroffenen als auch am kontralateralen Auge
    •Schwangerschaft und Stillzeit
    •Behandlung mit Kortikosteroiden oder Amilorid innerhalb von 30 Tagen vor Studieneinschluss
    •Immunmodulatorische oder immunsuppressive Therapie in der Vergangenheit.
    • Auffällige Natrium oder Kaliumwerte im Labor

    E.5 End points
    E.5.1Primary 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.
    Änderung der Dicke der retinalen Nervenzellschicht (gemessen mittels optischer Kohärenztomographie)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, after 8, 12 and 24 weeks
    Baseline, nach 8, 12 und 24 Wochen
    E.5.2Secondary 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).
    Änderung der Dicke der retinalen Ganglienzellschicht (gemessen mittels optischer Kohärenztomographie), Änderung der Latenz der visuell evozierten Potentiale, Verbesserung von Sehschärfe, Niedrig-Kontrast Sehschärfe, Farbsehen, Gesichtsfeld
    Änderung von MR-Parametern (Anzahl black holes, T2 Läsionen und kontrastmittelspeichernde Läsionen sowie Läsionsvolumen im Bereich des N. opticus)
    E.5.2.1Timepoint(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.
    Mit Ausnahme der MRT Untersuchung (nur zur Baseline und nach 24 Wochen) werden alle Untersuchungen zur Baseline, nach 8, 12 und 24 Wochen stattfinden.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    •LVLP
    •If adverse events occur which are so serious that the risk-benefit ratio is not acceptable.
    •If the number of dropouts is so high that proper completion of the trial cannot realistically be expected.
    •If recruitment problems are so severe that proper completion of the trial cannot realistically be expected.
    •LVLP
    •Bei Auftreten von schweren Nebenwirkungen, sodass das Nutzen-Risiko Profil nicht mehr akzeptabel ist.
    •Bei einer unerwartet hohen Drop-out Quote, sodass die Studie realistischerweise nicht zu Ende geführt werden kann.
    •Bei massiven Rekrutierungsproblemen, odass die Studie
    realistischerweise nicht zu Ende geführt werden kann.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 78
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state78
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After end of study and unblinding, treatment with amiloride HCT will be finished because according to previously published data on the development of optic nerve atrophy, an additional positive neuroprotective effect of a longer treatment period is not to be expected.
    Nach dem Abschluss der Studie ist eine weitere Therapie mit Amilorid HCT nicht geplant, da bei längerdauernder Therapie laut bisher publizierten Daten nicht mit einem zusätzlichen neuroprotektiven Effekt zu rechnen ist.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-08
    P. End of Trial
    P.End of Trial StatusOngoing
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