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    The EU Clinical Trials Register currently displays   41225   clinical trials with a EudraCT protocol, of which   6755   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-005630-60
    Sponsor's Protocol Code Number:TOZ-CL05
    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:2015-10-05
    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 number2014-005630-60
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-
    Controlled Study with an Open-Label Phase to Determine the
    Efficacy and Safety of Tozadenant as Adjunctive Therapy in
    Levodopa-Treated Patients with Parkinson´s Disease
    Experiencing End-of-Dose "Wearing-Off" (TOZ-PD)
    Estudio de fase III, multicéntrico, aleatorizado, doble ciego y controlado con placebo, con una fase en abierto para determinar la eficacia y la seguridad de tozadenant como tratamiento complementario en pacientes con enfermedad de Parkinson tratados con levodopa que experimentan esfumación de la respuesta ("wearing-off") (TOZ-PD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-
    Controlled Study with an Open-Label Phase to Determine the
    Efficacy and Safety of Tozadenant as Adjunctive Therapy in
    Levodopa-Treated Patients with Parkinson´s Disease
    Experiencing End-of-Dose "Wearing-Off" (TOZ-PD)
    Estudio de fase III, multicéntrico, aleatorizado, doble ciego y controlado con placebo, con una fase en abierto para determinar la eficacia y la seguridad de tozadenant como tratamiento complementario en pacientes con enfermedad de Parkinson tratados con levodopa que experimentan esfumación de la respuesta ("wearing-off") (TOZ-PD)
    A.3.2Name or abbreviated title of the trial where available
    TOZ-PD
    A.4.1Sponsor's protocol code numberTOZ-CL05
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02453386
    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 SponsorBiotie Therapies Inc.
    B.1.3.4CountryUnited States
    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 supportBiotie Therapies Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiotie Therapies Corp.
    B.5.2Functional name of contact pointAntero Kallio
    B.5.3 Address:
    B.5.3.1Street AddressJoukahaisenkatu 6
    B.5.3.2Town/ cityTurku
    B.5.3.3Post code20520
    B.5.3.4CountryFinland
    B.5.4Telephone number+3491432 26 30
    B.5.5Fax number+35822748910
    B.5.6E-mailAntero.Kallio@biotie.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 nameTozadenant
    D.3.2Product code SYN115
    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 INNTozadenant
    D.3.9.1CAS number 870070-55-6
    D.3.9.2Current sponsor codeSYN115
    D.3.9.3Other descriptive nameTOZADENANT
    D.3.9.4EV Substance CodeSUB130095
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    Parkinson´s Disease
    Enfermedad de Parkinson
    E.1.1.1Medical condition in easily understood language
    Parkinson´s Disease
    Enfermedad de Parkinson
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary efficacy objective of this study is to demonstrate the efficacy of the A2a receptor antagonist tozadenant in the treatment of levodopa-treated PD patients experiencing end-of-dose "wearing-off", based on the change from Baseline to Week 24 in the number of hours per day spent in the OFF state.
    Demostrar la eficacia del antagonista del receptor de A2a tozadenant en el tratamiento de pacientes con EP tratados con levodopa que experimenten esfumación de la respuesta, a través del cambio producido desde el momento inicial hasta la semana 24 en el número de horas al día transcurridas en estado sin efecto (OFF).
    E.2.2Secondary objectives of the trial
    The key secondary efficacy objectives of this study are:
    1. To evaluate the effect of tozadenant on good ON time (defined as the sum of ON time without dyskinesia and ON time with non-troublesome dyskinesia).
    2. To evaluate the effect of tozadenant on UPDRS Parts II (Activities of Daily Living [ADL] subscale) + III (motor subscale) total scores.
    Objetivos secundarios claves de eficacia (parte A):
    1. Evaluar el efecto del tozadenant sobre el tiempo bueno con efecto (ON) (definido como la suma del tiempo ON sin discinesia y el tiempo ON con discinesia no problemática).
    2. Evaluar el efecto del tozadenant sobre las puntuaciones totales en la escala unificada para la evaluación de la enfermedad de Parkinson (Unified Parkinson's Disease Rating Scale, UPDRS), partes II (subescala de Actividades de la vida cotidiana [AVC]) + III (subescala motora).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Patient understands study requirements and has given his/her written informed consent on an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved consent form.
    ? Parkinson's disease diagnosis consistent with UK Parkinson's Disease Society Brain Bank Diagnostic criteria
    ? Minimum of 3 years since diagnosis.
    ? Meet Hoehn and Yahr PD stage
    ? Good response to levodopa
    ? Stable regimen of anti-PD medications
    ? Patients must have been taking a levodopa-containing anti-PD medication continuously for at least the previous 12 months
    ? Patient has documented a minimum amount of Off time.
    ? If of childbearing potential (male and female) must use an acceptable method of contraception
    ? El paciente entiende los requisitos del estudio y ha otorgado su consentimiento informado en un formulario de consentimiento aprobado por la junta de revisión institucional (JRI) o el comité de ética de investigación clínica (CEIC).
    ? Diagnóstico de enfermedad de Parkinson de acuerdo con los criterios diagnósticos del Banco de Cerebros de la Sociedad de la Enfermedad de Parkinson del Reino Unido.
    ? Mínimo de 3 años desde el diagnóstico.
    ? Cumplir el estadio de Hoehn y Yahr para EP.
    ? Buena respuesta a levodopa.
    ? Pauta estable de medicamentos antiparkinsonianos.
    ? Los pacientes deben haber tomado de forma continua medicación antiparkinsoniana que contenga levodopa, al menos durante los 12 meses anteriores.
    ? Verificación de que el paciente tiene una cantidad mínima de tiempo en Off.
    ? Los pacientes (hombres y mujeres) en edad fértil deben utilizar un método anticonceptivo aceptable.
    E.4Principal exclusion criteria
    ? Previous tozadenant study participation
    ? Current or recent participation in another study.
    ? Secondary or atypical parkinsonism
    ? Neurosurgical intervention for PD
    ? Patient is taking apomorphine, budipine, istradefylline, tolcapone, or DUOPA?/Duodopa®
    ? Treatment with excluded medications
    ? Untreated or uncontrolled hyperthyroidism or hypothyroidism
    ? Clinically significant out-of-range laboratory
    ? MMSE out of range
    ? Current episode of major depression (stable treatment for depression is permitted).
    ? Recent suicide attempt or suicidal ideation type 4 or type 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS)
    ? Women lactating or pregnant
    ? Hypersensitivity to any components of tozadenant or excipients
    ? Abnormal findings on the physical or neurological examination, or medical history that would make the patient unsuitable for the study
    ? History of hepatitis or cholangitis
    ? Participación en el estudio anterior de tozadenant.
    ? Participación actual o reciente en otro estudio.
    ? Parkinsonismo secundario o atípico.
    ? Intervención neuroquirúrgica por EP.
    ? El paciente está tomando apomorfina, budipina, istradefilina, tolcapona o DUOPA?/Duodopa®.
    ? Tratamiento con medicamentos excluidos.
    ? Hipertiroidismo o hipotiroidismo no tratado o no controlado.
    ? Parámetros analíticos de importancia clínica fuera de su rango.
    ? MMSE fuera de rango.
    ? Episodio actual de depresión grave (se permite el tratamiento estable de la depresión).
    ? Intento reciente de suicidio o ideas de suicidio de tipo 4 o tipo 5 en la escala de valoración de la gravedad del suicidio de Columbia (C-SSRS).
    ? Mujeres embarazadas o en periodo de lactancia.
    ? Hipersensibilidad a cualquier componente de tozadenant o a los excipientes.
    ? Hallazgos anómalos en la exploración física o neurológica o antecedentes médicos que hagan que el paciente no sea adecuado para el estudio.
    ? Antecedentes de hepatitis o de colangitis.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint (Part A):
    The primary efficacy endpoint will be the change from Baseline to Week 24 in the number of hours per day spent in the OFF state, as assessed by patient-completed PD diaries and averaged over 3 consecutive days.
    Criterio de valoración principal de la eficacia (parte A):
    El criterio de valoración principal de la eficacia será el cambio producido entre el momento inicial y la semana 24 en el número de horas al día transcurridas en estado OFF, evaluado mediante diarios de la EP rellenados por el paciente y hallando la media de 3 días consecutivos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Analysis of the Primary Efficacy Variable
    The primary efficacy variable will be the change from Baseline to Week 24 in the number of hours per day spent in the OFF state, as assessed by patient-completed PD diaries and averaged over 3 consecutive days.
    Análisis de la variable principal de eficacia
    La variable principal de eficacia será el cambio producido entre el momento inicial y la semana 24 en el número de horas al día transcurridas en estado OFF, evaluado mediante diarios de la EP rellenados por el paciente y hallando la media de 3 días consecutivos
    E.5.2Secondary end point(s)
    Key Secondary Efficacy Endpoints (Part A):
    1. Change from Baseline to Week 24 in the number of hours per day spent in good ON time, defined as the sum of ON time without dyskinesia and ON time with non-troublesome dyskinesia.
    2. Change from Baseline to Week 24 on UPDRS Parts II (ADL subscale) + III (motor subscale) total scores.
    Criterios de valoración de la eficacia secundarios claves (parte A):
    1. Cambio producido entre el momento inicial y la semana 24 en el número de horas transcurridas al día con tiempo bueno ON, definido como la suma del tiempo ON sin discinesia y el tiempo ON con discinesia no problemática.
    2. Cambio producido entre el momento inicial y la semana 24 en las puntuaciones totales de las partes II (subescala AVC) + III (subescala motora) de la UPDRS.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Analysis of the key Secondary Efficacy Endpoints (Part A):
    1. Change from Baseline to Week 24 in the number of hours per day spent in good ON time, defined as the sum of ON time without dyskinesia and ON time with non-troublesome dyskinesia.
    2. Change from Baseline to Week 24 on UPDRS Parts II (ADL subscale) + III (motor subscale) total scores.
    Análisis de los criterios de valoración de la eficacia secundarios claves
    (parte A):
    1. Cambio producido entre el momento inicial y la semana 24 en el número de horas transcurridas al día con tiempo bueno ON, definido como la suma del tiempo ON sin discinesia y el tiempo ON con discinesia
    no problemática.
    2. Cambio producido entre el momento inicial y la semana 24 en las puntuaciones totales de las partes II (subescala AVC) + III (subescala motora) de la UPDRS.
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 trial3
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    European Union
    United States
    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
    The end of the study is defined as the date of the last visit of the last patient in the study.
    El final del estudio se define como la fecha de la última visita del último paciente en el estudio.
    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 days15
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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) Yes
    F.1.2.1Number of subjects for this age range: 158
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 292
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 450
    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 trial participation, the patients will receive the most appropriate treatment from their physician.
    Tras la participación en el estudio, los pacientes recibirán el tratamiento más adecuado de parte de su médico.
    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 Decision2015-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-01-12
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