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    Summary
    EudraCT Number:2014-001131-36
    Sponsor's Protocol Code Number:OS320-3005
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2014-09-03
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2014-001131-36
    A.3Full title of the trial
    A Multicenter, Randomized, Placebo-controlled, Double-blind, 16 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects with Levodopa-Induced Dyskinesias
    Estudio multicéntrico, aleatorizado, en doble ciego, controlado con placebo y de 16 semanas de duración, para evaluar la eficacia y la seguridad de la amantadina clorhidrato, comprimidos de liberación prolongada, en sujetos con enfermedad de Parkinson con discinesias inducidas por levodopa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 16 Week Clinical Study to Evaluate the Use of Long-Acting Amantadine to Treat Parkinson's Disease Patients with Abnormal Involuntary Movements caused by Levodopa
    Estudio de 16 semanas de duración, para evaluar el uso de la amantadina, comprimidos de liberación prolongada, en sujetos con enfermedad de Parkinson con movimientos involuntarios anormales causado por levodopa
    A.4.1Sponsor's protocol code numberOS320-3005
    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 SponsorOsmotica Pharmaceutical Corp.
    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 supportOsmotica Pharmaceutical Corp.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOsmotica Pharmaceutical Corp.
    B.5.2Functional name of contact pointGene Wright
    B.5.3 Address:
    B.5.3.1Street Address895 Sawyer Road
    B.5.3.2Town/ cityMarietta, Georgia
    B.5.3.3Post code30062
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34913913443
    B.5.5Fax number+1770-509-3943
    B.5.6E-mailgwright@osmotica.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 nameAmantadine HCl Extended Release
    D.3.4Pharmaceutical form Prolonged-release 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 INNAmantadine hydrochloride
    D.3.9.3Other descriptive nameAMANTADINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB00422MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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.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 nameAmantadine HCl Extended Release
    D.3.4Pharmaceutical form Prolonged-release 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 INNAmantadine hydrochloride
    D.3.9.3Other descriptive nameAMANTADINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB00422MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number240
    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.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 nameAmantadine HCl Extended Release
    D.3.4Pharmaceutical form Prolonged-release 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 INNAmantadine hydrochloride
    D.3.9.3Other descriptive nameAMANTADINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB00422MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number320
    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 placeboProlonged-release 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 placeboProlonged-release 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 placeboProlonged-release 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
    Parkinson's Disease Subjects with Levodopa-Induced Dyskinesias
    Sujetos con enfermedad de Parkinson, que presentan discinesias inducidas por levodopa
    E.1.1.1Medical condition in easily understood language
    Parkinson's Disease Subjects with Levodopa-Induced Dyskinesias
    Sujetos con enfermedad de Parkinson, que presentan discinesias inducidas por levodopa
    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 17.0
    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
    Demonstrate the efficacy of Amantadine Extended Release (ER) Tablets versus placebo on the Unified Dyskinesia Rating Scale (UDysRS) in patients with Levodopa-Induced Dyskinesia after 12 weeks of treatment at a fixed dose.
    Demostrar la eficacia de amantadina clorhidrato, comprimidos de liberación prolongada (ER), en comparación con un placebo en cuanto a la Unified Dyskinesia Rating Scale (UDysRS) con un tratamiento de mantenimiento de 12 semanas en pacientes con discinesias inducidas por levodopa
    E.2.2Secondary objectives of the trial
    - To compare the change in the percent of waking hours that subjects report being "OFF" during 12 weeks of treatment with Amantadine HCl ER Tablets versus placebo using the Mobility State Self-Assessment (Subject Diary Cards)

    - To compare the change in the percent of waking hours that subjects report having no dyskinesias during "ON" time during 12 weeks of treatment with Amantadine HCl Extended Release Tablets versus placebo using the Mobility State Self-Assessment (Subject Diary Cards)

    - To compare the change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score in Parts II and III, in Parkinson's Disease subjects with LID during 12 weeks of treatment with Amantadine HCl Extended Release Tablets versus placebo

    - To evaluate the relationship between amantadine plasma concentrations and clinical efficacy, safety and renal function during 12 weeks of treatment with Amantadine HCl Extended Release Tablets.
    - Comparar el cambio en el porcentaje de horas de vigilia en las que los sujetos declaran encontrarse en un estado "OFF" durante 12 semanas de tratamiento con amantadina HCl, comprimidos ER, frente a un placebo mediante la Mobility State Self-Assessment
    - Comparar el cambio en el porcentaje de horas de vigilia en las que los sujetos declaran no presentar discinesias durante el tiempo "ON" a lo largo de 12 semanas de tratamiento con amantadina HCl, comprimidos ER, frente a un placebo mediante la Mobility State Self-Assessment
    - Comparar el cambio en la puntuación de la (MDS-UPDRS) para las partes II y III, en sujetos con enfermedad de Parkinson que presentan DIL, a lo largo de un periodo de 12 semanas de tratamiento con amantadina HCl, comprimidos ER, frente a un placebo
    - Evaluar la relación entre las concentraciones plasmáticas de amantadina y la eficacia clínica, la seguridad y la función renal durante 12 semanas de tratamiento con amantadina HCl, comprimidos ER.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For a subject to be eligible for participation in this study, all of the following criteria must be met at screening. Subject must:
    - Sign an informed consent form (ICF) indicating that they have been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts.
    - Have been diagnosed with idiopathic Parkinson's disease as defined by the UK Parkinson's Disease Society Brain Bank criteria.
    - Be male or female 30 to 85 years old.
    - Have levodopa induced, predictable peak-effect dyskinesia that are considered by the subject to be problematic and/or disabling.
    - Have screening serum creatinine level within the normal range for the testing laboratory.
    - Have been on stable doses of all oral anti-Parkinson's medication, including any levodopa preparation, for 30 days and be willing to remain on the same doses throughout the course of the subject's participation in the trial.
    - The subject/caregiver must demonstrate the ability to complete an accurate home diary based on training and evaluation during the screening period.
    Para que un sujeto sea elegible para la participación en este estudio, deben cumplirse todos los criterios siguientes en el examen de selección. El sujeto debe:
    - Firmar un documento de consentimiento informado (ICF) que indique que ha sido informado de los procedimientos a seguir, la naturaleza experimental del tratamiento, las alternativas, los beneficios potenciales, los efectos secundarios, los riesgos y las molestias.
    - Haber sido diagnosticado de enfermedad de Parkinson idiopática según lo definido por los criterios de UK Parkinson's Disease Society Brain Bank.
    - Ser un varón o una mujer de entre 30 y 85 años de edad.
    - Presentar discinesias predecibles durante el efecto máximo inducidas por levodopa, que el sujeto considere problemáticas y/o invalidantes.
    - Presentar un nivel de creatinina en suero en el examen de selección situado dentro del rango normal del laboratorio que realiza el análisis.
    - Haber estado recibiendo tratamiento con dosis estables de toda la medicación antiparkinsoniana oral, incluidos los preparados de levodopa, durante 30 días y estar dispuesto a continuar con las mismas dosis durante todo el periodo de participación del sujeto en el ensayo.
    - El sujeto/cuidador debe demostrar su capacidad de completar un diario domiciliario de forma exacta, a juzgar por la capacitación y evaluación realizadas durante el periodo de examen de selección.
    E.4Principal exclusion criteria
    A subject will not be eligible for participation in this study if any of the following criteria apply. The subject:
    1. Is diagnosed with secondary parkinsonian syndrome, such as vascular, post-inflammatory, drug-induced, neoplastic and post-traumatic parkinsonism or any atypical parkinsonian syndrome (e.g., Progressive Supranuclear Palsy, Multi-System Atrophy, etc.)
    2. Has used amantadine in any dosage or pharmaceutical form within the past 14 days, or has previously interrupted the use of amantadine due to an adverse event
    3. Is currently using medications that would potentially interfere with the actions of the study medication or outcome variables, including neuroleptics and atypical antipsychotic agents, acetylcholinesterase inhibitors, apomorphine, rimantadine, memantine and dextromethorphan and quinidine if used in combination for treating dyskinesia.
    4. Has a history of pallidotomy or other ablative surgery for the treatment of PD, or is implanted with a uni- or bilateral deep brain stimulator
    5. Has any medical condition or past medical history that, in the Investigator's judgment, would increase the risk of exposure to Amantadine HCl Extended Release Tablets or interfere with safety and efficacy evaluations. These include:
    o seizure disorders or history of seizures other than childhood febrile convulsions
    o history of glaucoma
    o current hallucinations
    o urinary retention
    o abuse of legal or illegal drugs within the past 12 months
    6. Has a history of cancer within 5 years of screening that may compromise the life-expectancy of the subject; exceptions are adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer or in situ cervical cancer.
    7. Has a history or current diagnosis of schizophrenia or bipolar disorder
    8. Has current diagnosis of inadequately treated Major Depressive Disorder. Subjects who are on stable doses of selective serotonin reuptake inhibitors (SSRIs) or serotonin -norepinephrine reuptake inhibitors (SNRIs) for depression are eligible for the study
    9. Is at imminent risk of suicide (score of 4 or 5 on the C-SSRS) or had a suicide attempt within 6 months of the screening visit.
    10. Has a history of, or current diagnosis of Impulse Control Disorder or is judged to be at risk according to the QUIP-RS
    11. Has an estimated plasma creatinine clearance of <60 mL/min at screening using the Cockroft-Gault equation
    12. Has a history of or currently has any of the following clinically significant conditions, that in the investigator's opinion may interfere with the study procedures or compromise the subject's safety:
    o Cardiovascular disease
    o Respiratory disease
    o Renal disease
    o Hepatic disease
    o Gastrointestinal disease
    13. Upon evaluation at the screening visit, the subject has:
    o Any clinically significant vital sign, ECG, or laboratory abnormalities
    o A positive test for human immunodeficiency virus (HIV) antibody of a history of HIV
    o A positive test for hepatitis B surface antigen unless the positive test followed a recent (<28 days) vaccination for hepatitis B and the vaccination record is available
    o A positive test for hepatitis C antibody
    o A positive urine drug test
    14. The subject is female, and is pregnant or lactating (breastfeeding) at the time of screening or has a positive pregnancy test result pre-dose
    15. If a sexually active female, is not surgically sterile or at least 2 years post-menopausal, or does not agree to utilize an effective method of contraception from the screening visit to at least 4 weeks after the completion of study treatment.
    16. Has a history of alcohol or narcotic substance abuse, as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), ?1 year before the screening visit. Has dementia or another psychiatric illness that prevents provision of informed consent.
    17. Has a known hypersensitivity to the study treatment(s), based on known allergies to drugs of the same class including rimantadine HCl and memantine HCl.
    18. Has participated in other studies involving investigational drugs or surgeries within the last 30 days or investigational biologics within the last 6 months prior to the screening visit.
    19. Plans to undergo major elective surgery during the course of the study.
    20. Has received administration of Live Attenuated Influenza Vaccine (LAIV) within 2 weeks.
    21. Presence of cognitive impairment, as evidenced by a score <26 on the Montreal Cognitive Assessment (MoCA) at the screening visit.
    Un sujeto no será elegible para la participación en este estudio si se cumple cualquiera de los siguientes criterios. El sujeto:
    1. Tiene un diagnóstico de síndrome parkinsoniano secundario, como un parkinsonismo vascular, postinflamatorio, inducido por sustancias, neoplásico o postraumático, o cualquier síndrome parkinsoniano atípico
    2. Ha utilizado amantadina en cualquier dosis o forma farmacéutica en los últimos 14 días, o ha interrumpido anteriormente el uso de amantadina a causa de un AA
    3. Está utilizando actualmente medicamentos que podrían interferir en las acciones de la medicación en estudio o en las variables de valoración, como neurolépticos y antipsicóticos atípicos, inhibidores de la acetilcolinesterasa, apomorfina, rimantadina, memantina y dextrometorfano y quinidina, si se utilizan de forma combinada para tratar la discinesia
    4. Tiene antecedentes de palidotomía u otra intervención quirúrgica ablativa para el tratamiento de la EP, o se le ha implantado un estimulador cerebral profundo unilateral o bilateral
    5. Tiene trastorno médico o antecedente patológico que, a juicio del investigador, pudiera aumentar el riesgo de la exposición a amantadina HCl, comprimidos ER o interferir en las evaluaciones de la seguridad y la eficacia. Entre ellos se encuentran los siguientes: o crisis epilépticas o antecedentes de crisis epilépticas excepto las convulsiones febriles infantiles; o antecedentes de glaucoma; o alucinaciones actuales; o retención de orina; o abuso de drogas legales o ilegales en los últimos 12 meses
    6. Tiene antecedentes de cáncer en los últimos 5 años anteriores al examen de selección que puedan comprometer la esperanza de vida del sujeto; son excepciones los cánceres cutáneos no melanomatosos, el cáncer de vejiga urinaria localizado, el cáncer de próstata no metastásico o el cáncer de cuello uterino in situ, adecuadamente tratados
    7. Tiene antecedentes o un diagnóstico actual de esquizofrenia o trastorno bipolar
    8. Tiene un diagnóstico actual de trastorno depresivo mayor insuficientemente tratado. Los sujetos que estén en tratamiento con dosis estables de (ISRS) o (IRSN) para la depresión son elegibles para el estudio
    9. Tiene un riesgo inminente de suicidio o ha tenido un intento de suicidio en los 6 meses previos
    10. Tiene antecedentes o un diagnóstico actual de trastorno de control de impulsos o se considera que tiene riesgo de sufrirlo según la QUIP-RS.
    11. Tiene un aclaramiento de creatinina plasmática estimado (mediante la ecuación de Cockroft-Gault) <60 ml/min
    12. Tiene antecedentes o presenta actualmente cualquiera de los siguientes trastornos clínicamente significativos que, en opinión del investigador, pueda interferir en los procedimientos del estudio o comprometer la seguridad del sujeto: o Enfermedad cardiovascular; o Enfermedad respiratoria; o Enfermedad renal; o Enfermedad hepática; o Enfermedad gastrointestinal
    13. Tras la evaluación de la visita de examen de selección, el sujeto tiene: o Anomalía clínicamente significativa de las constantes vitales, el ECG o los análisis de laboratorio; o Prueba positiva para anticuerpos contra el virus VIH o antecedentes de VIH; o Prueba positiva para el antígeno de superficie del virus de la hepatitis B, salvo que la prueba positiva se haya producido después de una vacunación reciente (<28 días) contra la hepatitis B y se disponga de un registro de dicha vacunación; o Prueba positiva para anticuerpos contra el virus de la hepatitis C; o Prueba de sustancias en orina positiva
    14. El sujeto es una mujer que está embarazada o en periodo de lactancia en el momento del examen de selección o tiene un resultado positivo de una prueba de embarazo antes de la administración de la dosis
    15. Es una mujer sexualmente activa, que no ha sido esterilizada quirúrgicamente o no han transcurrido un mínimo de 2 años tras la menopausia, o no acepta utilizar un método de anticoncepción efectivo desde la visita de examen de selección y hasta al menos 4 semanas después de completado el tratamiento en estudio
    16. Tiene antecedentes de abuso de alcohol o de sustancias narcóticas según lo definido en el (DSM-V), ?1 año antes de la visita de examen de selección. Presenta demencia u otra enfermedad psiquiátrica que le impida dar un consentimiento informado
    17. Tiene una hipersensibilidad conocida al tratamiento o tratamientos en estudio, en función de alergias conocidas a fármacos de la misma clase, incluida rimantadina HCl y memantina HCl
    18. Ha participado en otros estudios en los que se han utilizado fármacos o intervenciones quirúrgicas en fase de investigación en los últimos 30 días o agentes biológicos en fase de investigación en los últimos 6 meses
    19. Tiene programada una intervención de cirugía mayor electiva durante el curso del estudio
    20. Se le ha administrado una vacuna antigripal de virus atenuados (LAIV) en las últimas 2 semanas
    21. Presencia de un deterioro cognitivo, evidenciado por una puntuación <26 en la (MoCA)
    E.5 End points
    E.5.1Primary end point(s)
    The change from baseline to Day 98 (Visit 7) of treatment in the sum of the items comprising the Unified Dyskinesia Rating Scale (UDysRS).
    El cambio respecto al valor inicial en el día 98 (visita 7) de tratamiento en la suma de los ítems que forman la Unified Dyskinesia Rating Scale (UDysRS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 98 (Visit 7)
    Día 98 (visita 7)
    E.5.2Secondary end point(s)
    Secondary Endpoints - Efficacy
    - The change from baseline to Day 14 (Visit 4), Day 42 (Visit 5), Day 70 (Visit 6), Day 98 (Visit 7) of treatment in the sum of the items comprising the Unified Dyskinesia Rating Scale (UDysRS).
    - The change from baseline to Day 14 (Visit 4), Day 42 (Visit 5), Day 70 (Visit 6), Day 98 (Visit 7) of treatment in the percent of waking hours that subjects report being "OFF" in the Mobility State Self-Assessment (Subject Diaries).
    - The change from baseline to Day 14 (Visit 4), Day 42 (Visit 5), Day 70 (Visit 6), Day 98 (Visit 7) of treatment in the percent of waking hours that subjects report being "ON" having no dyskinesias, non-troublesome dyskinesias, and troublesome dyskinesias in the Mobility State Self-Assessment (Subject Diaries).
    - The change from baseline to Day 14 (Visit 4), Day 42 (Visit 5), Day 70 (Visit 6), Day 98 (Visit 7) of treatment in the sum of Parts II, and III of the MDS-UPDRS.
    - The change from baseline to Day 14 (Visit 4), Day 42 (Visit 5), Day 70 (Visit 6), Day 98 (Visit 7) in the Fatigue Severity Scale (FSS);

    Secondary Endpoints - Safety
    - Safety and tolerability of Amantadine HCl Extended Release Tablets as assessed by frequency and nature of adverse events (AEs), laboratory results, vital sign measurements, physical examinations, and 12-lead electrocardiograms (ECGs);
    - Assessment of the potential occurrence of psychiatric side effects (SCOPA-PC), sleep disorders, Livedo Reticularis and orthostatic hypotension;
    - Assessment of suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS) (Baseline/Screening), (Since Last Visit);
    - Assessment of potential occurrence of Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease ? Rating Scale (QUIP-RS)
    - Relationship of plasma amantadine concentrations to clinical efficacy, safety, and renal function.
    Variables de valoración secundarias - Eficacia
    - El cambio respecto al valor inicial en el día 14 (Visita 4), el día 42 (Visita 5), el día 70 (Visita 6) y el día 98 (Visita 7) de tratamiento en la suma de los ítems que forman la Unified Dyskinesia Rating Scale (UDysRS).
    - El cambio respecto al valor inicial en el día 14 (Visita 4), el día 42 (Visita 5), el día 70 (Visita 6) y el día 98 (Visita 7) de tratamiento en el porcentaje de horas de vigilia que los sujetos declaran estar en estado "OFF" en la Mobility State Self-Assessment (diario del sujeto)
    - El cambio respecto al valor inicial en el día 14 (Visita 4), el día 42 (Visita 5), el día 70 (Visita 6) y el día 98 (Visita 7) de tratamiento en el porcentaje de horas de vigilia que los sujetos declaran estar en estado "ON" sin discinesias, con discinesias no molestas y con discinesias molestas en la Mobility State Self-Assessment (diario del sujeto)
    - El cambio respecto al valor inicial en el día 14 (Visita 4), el día 42 (Visita 5), el día 70 (Visita 6) y el día 98 (Visita 7) de tratamiento en la suma de las Partes II y III de la MDS-UPDRS
    - El cambio respecto al valor inicial en el día 14 (Visita 4), el día 42 (Visita 5), el día 70 (Visita 6) y el día 98 (Visita 7) en la Fatigue Severity Scale (FSS);

    Variables de valoración secundarias - Seguridad
    - Seguridad y tolerabilidad de amantadina clorhidrato, comprimidos de liberación prolongada, evaluadas mediante la frecuencia y la naturaleza de los acontecimientos adversos (AA), resultados de análisis de laboratorio, determinaciones de las constantes vitales, exploraciones físicas y electrocardiogramas (ECG) de 12 derivaciones;
    - Evaluación de la posible aparición de efectos secundarios psiquiátricos (SCOPA-PC), trastornos del sueño, livedo reticular e hipotensión ortostática;
    - Evaluación de las tendencias suicidas mediante la Columbia-Suicide Severity Rating Scale (C-SSRS) (inicial/examen de selección), (desde la visita final);
    - Evaluación de la posible aparición de un trastorno de control de impulsos mediante la Questionnaire for Impulsive-Compulsive Disorders in Parkinson?s Disease ? Rating Scale (QUIP-RS)
    - Relación de las concentraciones plasmáticas de amantadina con la eficacia clínica, la seguridad y la función renal.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary Endpoints - Efficacy:
    - Day 14 (Visit 4), Day 42 (Visit 5), Day 70 (Visit 6), Day 98 (Visit 7) of treatment

    Secondary Endpoints - Safety:
    - Until Day 112 (Final Visit)
    Variables de valoración secundarias - Eficacia:
    - Día 14 (Visita 4), Día 42 (Visita 5), Día 70 (Visita 6), Día 98 (Visita 7) de tratamiento

    Variables de valoración secundarias - Seguridad:
    - Hasta Día 112 (Visita final)
    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 Yes
    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 EEA25
    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
    France
    Germany
    Spain
    United States
    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
    LVLS
    Última visita del último sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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: 46
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 116
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 162
    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)
    No post-study medication will be provided. The investigator is responsible for ensuring that consideration has been given to the post-study care of the patient's medical condition.
    No se proporcionará ninguna medicación para después del estudio. El investigador es responsable de asegurarse de que se han tenido en cuenta los cuidados para después del estudio para el trastorno médico del paciente.
    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 Decision2014-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-08
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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