Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7292   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2008-001432-13
    Sponsor's Protocol Code Number:MRZ92579TI3004
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-01-19
    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 number2008-001432-13
    A.3Full title of the trial
    Estudio abierto de tratamiento a largo plazo para evaluar la seguridad, la tolerabilidad y la eficacia a largo plazo de neramexano en pacientes con acúfenos subjetivos

    An Open-Label, Long-Term Treatment Study to assess the Long-Term Safety and Tolerability and Efficacy of Neramexane in Patients with Subjective Tinnitus
    A.4.1Sponsor's protocol code numberMRZ92579TI3004
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerz Pharmaceuticals GmbH
    B.1.3.4CountryGermany
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameNeramexano mesilato 12,5mg comprimidos recubiertos con película de liberación inmediata
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNNeramexano mesilato
    D.3.9.1CAS number 457068-92-7
    D.3.9.3Other descriptive name1-amino-1,3,3,5,5-pentametilciclohexano mesilato
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.IMP: 2
    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 nameNeramexano mesilato 25 mg comprimidos recubiertos con película de liberación inmediata
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNNeramexano mesilato
    D.3.9.1CAS number 457068-92-7
    D.3.9.3Other descriptive name1-amino-1,3,3,5,5-pentametilciclohexano mesilato
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.IMP: 3
    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 nameNeramexano mesilato 37,5 mg comprimidos recubiertos con película de liberación inmediata para admin
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNNeramexano mesilato
    D.3.9.1CAS number 457068-92-7
    D.3.9.3Other descriptive name1-amino-1,3,3,5,5-pentametilciclohexano mesilato
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number37.5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Acúfenos subjetivos

    Long-term safety, tolerability and efficacy of Neramexane in Patients with subjective Tinnitus.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10042398
    E.1.2Term Subjective tinnitus
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal del estudio es evaluar la seguridad y la tolerabilidad a largo plazo de dosis diarias de 50 o 75 mg (dependiendo de la dosis fija del estudio previo respectivo) de neramexano mesilato en el tratamiento de los acúfenos subjetivos.
    E.2.2Secondary objectives of the trial
    El estudio también investigará la durabilidad de los efectos del tratamiento (eficacia a largo plazo).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Consentimiento informado firmado obtenido del paciente
    2) Pacientes de ambos sexos que hayan finalizado con éxito uno de los estudios doble ciego MRZ 92579 TI 3001, MRZ 92579 TI 3002 o MRZ 92579 TI 3003 y que a juicio de los investigadores se consideren aptos, en base a los criterios de inclusión/exclusión.
    3) Al inicio del estudio doble ciego el paciente cumplía los criterios diagnósticos para acúfenos subjetivos de primera aparición, persistentes, unilaterales o bilaterales.
    4) Para mujeres en edad fértil (última regla en menos de un año antes de la admisión): prueba de embarazo negativa en el momento basal; no está amamantando; quirúrgicamente estéril o acuerdo para utilizar métodos anticonceptivos médicamente aceptados y altamente eficaces durante la totalidad de la duración del estudio. Un método anticonceptivo altamente eficaz se define como aquellos que presentan un bajo índice de fracaso (es decir, menos de 1% al año) cuando se utiliza de forma sistemática y correcta, como implantes, inyectables, anticonceptivos orales combinados, algunos DIU, abstinencia sexual o cónyuge con vasectomía.
    5) El paciente debe tener la voluntad y ser capaz de cumplir con el protocolo y los procedimientos del estudio.
    E.4Principal exclusion criteria
    1) Diagnóstico clínico de acúfenos intermitentes o pulsátiles
    2) Pacientes con acúfenos como síntoma concomitante de una patología otológica/neurológica (como otitis media, enfermedad de Menière, otoesclerosis, etc.)
    3) Pacientes con signos de trastornos, clínicamente relevantes y activos
    - pulmonares
    - Sistema cardiovascular
    - renales
    - hepáticos
    - gastrointestinales
    - neurológicos (p. ej., crisis epilépticas, esclerosis múltiple, traumatismo craneoencefálico/cervical grave con secuelas)
    - psiquiátricos (p. ej., demencia, esquizofrenia, episodio depresivo mayor actual)
    - infecciosos (p. ej., infección por VIH/SIDA, tuberculosis)
    - endocrinos
    de interés u otras enfermedades sistémicas graves o no controladas que pudieran interferir con el ensayo (pueden incluirse los pacientes con diabetes controlada normoglucémicos bajo tratamiento).
    4) Presión arterial sistólica (en sedestación) > 180 mmHg o < 90 mmHg o presión arterial diastólica (en sedestación) > 105 mmHg o < 45 mmHg
    5) Pacientes con diagnóstico oncológico (hematología o tumor sólido) sometidos a tratamiento, que han finalizado el tratamiento en los últimos 6 meses, o que siguen mostrando signos de enfermedad activa. (Pueden incluirse pacientes con lesiones cutáneas benignas localizadas)
    6) Tratamiento anterior con memantina, rimantadina, amantadina
    7) Historia documentada de hipersensibilidad o intolerancia a antagonistas de NMDA
    8) Hipersensibilidad conocida al medicamento del estudio o a uno de los componentes de la formulación
    9) Absentismo laboral actual por acúfenos o solicitud o concesión de una pensión de jubilación o incapacidad por acúfenos
    10) Medicamentos y suplementos concomitantes para el tratamiento de los acúfenos y tratamientos no farmacológicos, p. ej., biofeedback, enmascaradores, generadores de ruidos, acupuntura, oxigenoterapia hiperbárica, terapia con láser de baja potencia, entrenamiento autogénico, terapia conductual o psicoterapia.
    11) Pacientes que están tomando cualquier medicación concomitante no autorizada según lo definido en el Anexo 4 del protocolo del estudio
    12) Pacientes que planean someterse a una cirugía programada con anestesia local o general durante el estudio
    13) Alcoholismo o drogodependencia conocidos o sospechados en los últimos 3 años
    14) Pacientes que han participado en un estudio clínico que no sea ninguno de los estudios doble ciego MRZ 92579/TI/3001, MRZ 92579/TI/3002 o MRZ 92579/TI/3003 en los últimos 30 días (o 5 semividas del fármaco, lo que sea más largo)
    15) Mujeres embarazadas o en período de lactancia
    16) Empleados o parientes directos de un empleado de la CRO, del centro de investigación o de Merz Pharmaceuticals
    17) Pacientes que residen legalmente en un centro de asistencia o que están en prisión
    18) La aparición de cualquier acontecimiento adverso importante que surja con el tratamiento, o cualquier enfermedad, durante el protocolo anterior (MRZ 92579/TI/3001, MRZ 92579/TI/3002 o MRZ 92579/TI/3003) que, según la opinión de los investigadores, debería excluir al paciente de participar en el estudio del tratamiento abierto a largo plazo.
    19) Cuestiones relevantes de incumplimiento con el protocolo anterior o bien antecedentes de incumplimiento crónico con las pautas posológicas
    20) Prueba o sospecha de que el paciente no desea o es incapaz de comprender la información que se le da como parte del consentimiento informado, sobre todo, en lo que respecta a los riesgos y las molestias a los que estaría dispuesto a estar expuesto.
    E.5 End points
    E.5.1Primary end point(s)
    El estudio actual está diseñado para investigar la seguridad a largo plazo de neramexano en pacientes que han finalizado uno de los estudios clínicos MRZ 92579/TI/3001, 3002 ó 3003. Además del efecto a largo plazo sobre las variables de eficacia, también se investigarán el TBF-12, la escala de valoración de acúfenos y el SF-36.
    No se pretende realizar ninguna prueba de hipótesis estadística de confirmación. El estudio se analizará sólo descriptivamente. Además de las mediciones basales del respectivo estudio de preinclusión, sólo se incluirán los datos de seguridad y eficacia del estudio OLLTT actual. Cualquier conjunto de datos de preinclusión y OLLTT estará sujeto al resumen de seguridad integrado.
    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 No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerabilidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA126
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-01-19. Yes
    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 state77
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 531
    F.4.2.2In the whole clinical trial 840
    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 Decision2009-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue May 07 07:40:04 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA