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    Summary
    EudraCT Number:2016-002281-31
    Sponsor's Protocol Code Number:Piromelatine-IOP1
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-07-15
    Trial results View 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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-002281-31
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, study of oral treatment of piromelatine in patients with ocular hypertension (OHT) or primary open angle glaucoma (POAG).
    Estudio aleatorizado, doble ciego, controlado con placebo, del tratamiento oral con piromelatina en pacientes con hipertensión ocular (HTO) o con glaucoma primario de ángulo abierto (GPAA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    treatment of piromelatine in patients with ocular hypertension or primary open angle glaucoma.
    Tratamiento con Piromelatina en pacientes con hipertensión ocular o con glaucoma primario de ángulo abierto
    A.4.1Sponsor's protocol code numberPiromelatine-IOP1
    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 SponsorNeurim Pharmaceuticals (1991) Ltd.
    B.1.3.4CountryIsrael
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNeurim Pharmaceuticals (1991) Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQPS Austria
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressParkring 12
    B.5.3.2Town/ cityGrambach
    B.5.3.3Post code8074
    B.5.3.4CountryAustria
    B.5.4Telephone number004331625811
    B.5.5Fax number0043316258111300
    B.5.6E-mailRicarda.Cerroni@qps.com
    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 No
    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 namePiromelatine
    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 INNPiromelatine
    D.3.9.1CAS number 946846-83-9
    D.3.9.3Other descriptive namePiromelatine is also known by the laboratory code Neu-P11. Neu-P11 was used in two previous clinical trials conduct in the EU: Germany 2008 (EudraCT number 2008-002181-59) and France 2009 (EudraCT number 2009-017698-39)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboTablet
    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
    ocular hypertension
    primary open angle glaucoma
    Hipertensión ocular
    Glaucoma primario de ángulo abierto
    E.1.1.1Medical condition in easily understood language
    ocular hypertension
    primary open angle glaucoma
    Hipertensión ocular
    Glaucoma primario de ángulo abierto
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    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
    Primary Objective:
    To evaluate the safety and tolerability of 30 days piromelatine treatment vs placebo in ocular hypertension (OHT) or primary open angle glaucoma (POAG) patients.
    Objetivo Primario:
    Evaluar la seguridad y tolerancia de 30 días de tratamiento con piromelatina frente a placebo en pacientes con hipertensión ocular (HTO) o glaucoma primario de ángulo abierto (GPAA)
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    1. To compare the effect of the piromelatine treatment to that of placebo on mean intraocular pressure (IOP) after 30 days of double blind treatment
    2. To compare the effect of 30 days piromelatine treatment to that of placebo on night time IOP.
    3. To compare the effect of 30 days piromelatine treatment to that of placebo on daytime IOP.
    4. To compare the effect of 30 days piromelatine treatment to that of placebo on mean postural (supine-sitting) fluctuations (PFs) of IOP during the day
    5. To compare the effect of 30 days piromelatine treatment to that of placebo on mean diurnal variation (DV) of IOP in supine position
    Objetivos Secundarios:
    1. Comparar el efecto del tratamiento con piromelatina con el del placebo sobre la presión intraocular (PIO) media después de 30 días de tratamiento doble ciego
    2. Comparar el efecto del tratamiento durante 30 días con piromelatina con el del placebo sobre la PIO nocturna.
    3. Comparar el efecto del tratamiento durante 30 días con piromelatina con el del placebo sobre la PIO diurna.
    4. Comparar el efecto del tratamiento durante 30 días con piromelatina con el del placebo sobre las fluctuaciones posturales (FPs) medias (en decúbito supino-sedestación) de la PIO diurna
    5. Comparar el efecto del tratamiento durante 30 días con piromelatina con el del placebo sobre la variación diurna (VD) media de la PIO en decúbito supino
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Aged between 40 and 80 years, of either sex.
    2. Clinical diagnosis of either POAG or OHT in both eyes
    3. Morning IOP (09:00 am ±1h ) of 22-30 mm Hg (inclusive).
    4. POAG patients that DO NOT receive any IOP lowering therapy will be allowed in the study. OHT patients that received IOP lowering medication for a brief period of time and are free from this kind of medication in the 6 months prior to study start will be allowed in the study.
    5. Women of childbearing potential use a reliable method of contraception during the entire study duration and for at least 3 months after study drug intake.
    6. Male patients and their female spouse/partners who are of childbearing potential must agree to use highly effective methods of contraception, consisting of two forms of birth control (at least one of which must be a barrier method) starting at Screening, throughout the study and for 90 days post-last dose, OR be surgically sterile.
    7. Willing and able to attend all study-related visits and be housed overnight at clinical site for the study assessments.
    8. Must sign an Informed Consent form.
    1. Edad comprendida entre los 40 y los 80 años, de ambos sexos.
    2. Diagnóstico clínico de GPAA o HTO en ambos ojos.
    3. PIO matutina (09:00 am ±1h) de 22-30 mm Hg (ambas inclusive).
    4. Los pacientes con GPAA que NO reciben ningún tratamiento para bajar la PIO podrán participar en el estudio. Los pacientes con HTO que hayan recibido medicación para bajar la PIO durante un breve periodo de tiempo y estén sin este tipo de medicación en los 6 meses anteriores al inicio del estudio podrán participar en el estudio.
    5. Las mujeres en edad fértil que utilicen un método anticonceptivo seguro durante todo el estudio y durante al menos 3 meses después de la toma del fármaco del estudio.
    6. Los pacientes varones y sus cónyuges /de sexo femenino que estén en edad fértil deben aceptar usar métodos de contracepción altamente efectivos, consistentes en dos formas de control de natalidad (al menos uno de los cuales debe ser un método de barrera) empezando en la selección, a lo largo de todo el estudio, y durante 90 días después de la última dosis, O ser quirúrgicamente estériles.
    7. Poder y estar dispuesto a asistir a todas las visitas relacionadas con el estudio, y a ser ingresados durante toda la noche en el centro clínico para las evaluaciones del estudio.
    8. Debe firmar un formulario de Consentimiento Informado.
    E.4Principal exclusion criteria
    Major Exclusion Criteria:
    • A patient with OHT or POAG currently on treatment
    • A patient with POAG previously treated (regardless of the date treatment was discontinued), or a patient with OHT treated less than 6 months prior to study start.
    • Any other glaucoma type (including but not limited to Angle Closure Glaucoma, Secondary Glaucoma, Childhood Glaucoma), and specifically other secondary open angle glaucoma including PSX and Pigmentary glaucoma.
    • Very advanced visual field loss in either eye (see Appendix 1).
    • patients with any central defects within 5º of fixation or with a central defect within 10º of fixation defined as two or more points with a sensitivity < 20 Db
    • Chronic, recurrent or severe inflammatory eye disease.
    • Ocular trauma or ocular surgery within the past 6 months.
    • Ocular infection or ocular inflammation within the past 3 months.
    • Clinically significant or progressive retinal disease.
    • Other ocular pathology, that may in the opinion of the investigator preclude the administration of study medication.
    • Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study.
    • Pregnant, intend to become pregnant, breastfeeding.
    • Participation in other clinical research within the last 3 months
    Principales Criterios de Exclusión
     Paciente con HTO o GPAA en tratamiento actualmente.
     Paciente con GPAA tratado previamente (con independencia de la fecha en la que se haya interrumpido el tratamiento) o paciente con HTO tratado en menos de 6 meses antes de iniciar el estudio
     Cualquier otro tipo de glaucoma (incluido, a título enumerativo pero no limitativo, el glaucoma de ángulo cerrado, glaucoma secundario, glaucoma de la infancia), y específicamente otros tipos de glaucoma secundario de ángulo abierto incluyendo glaucoma pseudoexfoliativo (PSX) y glaucoma pigmentario.
     Pérdida de campo visual muy avanzada en cualquiera de los ojos (véase Apéndice 1).
     Pacientes con cualquier defecto central dentro de 5º de fijación o con un defecto central dentro de 10º de fijación definido como dos o más puntos con una sensibilidad <20 Db
     Enfermedad inflamatoria ocular crónica, recurrente o severa.
     Traumatismo ocular o cirugía ocular en los últimos 6 meses.
     Infección ocular o inflamación ocular en los últimos 3 meses.
     Enfermedad retiniana clínicamente significativa o progresiva.
     Otra patología ocular que en opinión del investigador pueda impedir la administración del medicamento del estudio.
     Cualquier otra patología, incluyendo enfermedad grave, que en opinión del investigador haga que el paciente no sea apto para el estudio.
     Embarazo, intención de quedarse embarazada, lactancia materna.
     Participación en otra investigación clínica en los últimos 3 meses
    E.5 End points
    E.5.1Primary end point(s)
    The safety parameters will be summarized using descriptive statistics: n, mean, median, standard deviation (SD), standard error of the mean (SEM), minimum, maximum, number of out-of-range values if applicable,

    Los parámetros de seguridad se resumirán mediante estadística descriptiva: n, media, mediana, desviación estándar (SD), error estándar de la media (EEM), mínimo, máximo, número de valores fuera del rango si procede.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Screening, Baseline (Visit 2), Visit 3 and Visit 4
    Selección, Visita basal (Visita 2), Visita 3 y Visita 4
    E.5.2Secondary end point(s)
    Secondary endpoints:
    • IOP – Intraocular pressure at supine and sitting position at night time and during the day
    • PF – The difference of IOP in the supine and sitting position at each time point.
    • DV – The difference between maximum and minimum IOP during the 24 h period DV for sitting and supine postures
    Exploratory endpoints
    • Sleep questionnaire items
    • Ambulatory blood pressure monitoring (ABPM)
    Variables Secundarias:
    PIO – Presión intraocular en decúbito supino y en sedestación durante la noche y durante el día
     FP – La diferencia entre la PIO en decúbito supino y en sedestación en cada punto temporal.
     VD – La diferencia entre la PIO máxima y mínima durante el periodo de 24 h (VD) para sedestación y decúbito supino
    Variables Exploratorias:
     Items del cuestionario del sueño
     Monitorización Ambulatoria de la Presión Arterial (MAPA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline (Visit 2), Visit 3 and Visit 4
    Visita basal (Visita 2), Visita 3 y Visita 4
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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 Yes
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 No
    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
    The end of the clinical study is defined as the last protocol-specified contact with a patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial 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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 47
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 47
    F.4.2.2In the whole clinical trial 47
    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)
    not different from the expected normal treatment of that condition
    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 Decision2016-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-13
    P. End of Trial
    P.End of Trial StatusCompleted
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