Clinical Trial Page

Summary
EudraCT Number:2007-001717-42
Sponsor's Protocol Code Number:P05175
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:2007-10-26
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
A. Protocol Information
A.1Member State ConcernedSpain - AEMPS
A.2EudraCT number2007-001717-42
A.3Full title of the trial
Estudio de fase II y 36 semanas de duración, abierto y no comparativo, de seguimiento de la seguridad de 5 mg de SCH 420814 d.v.d.
A.3.2Name or abbreviated title of the trial where available
N/A
A.4.1Sponsor's protocol code numberP05175
A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
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 SponsorSchering Plough Research Institute
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 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 nameSCH 420814
D.3.2Product code N/A
D.3.4Pharmaceutical form Capsule, hard
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.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number5
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
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
En pacientes con enfermedad de Parkinson moderada o grave que presentan fluctuaciones motoras y discinesias
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
Evaluar la seguridad de la dosis de 5 mg d.v.d. de SCH 420814 en pacientes con Enfermedad de Parkinson moderada o grave que reciben una pauta de tratamiento con L-dopa/inhibidores de la dopa-decarboxilasa y agosnistas dopaminérgicos mediante el análisis de la proporción de pacientes que refieren efectos adversoso y resultados de laboratorio anormales durante 36 semanas de tratamiento abierto y comparándolo con sus antecedentes.
E.2.2Secondary objectives of the trial
Valorar la duración de los periodos off durante y hasta el fin del estudio en comparación con el valor basal.
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria

Los pacientes deben haber participado en el P04501.
Los pacientes deben ser mayores de 30 años y pueden ser hombres o mujeres de cualquier raza con un diagnóstico de enfermedad de Parkinson idiopática moderada o grave de 5 años de evolución como mínimo.
Los pacientes deben haber recibido una pauta de L-dopa y un agonista dopaminérgico.
Los pacientes deben presentar una TA sistólica ≤160 mm Hg y una TA diastólica ≤90 mm Hg.
Las mujeres fértiles deben obtener resultado negativo en la prueba de embarazo en suero de la visita 1. Si la paciente es menopáusica (no por intervención quirúrgica), debe constar en su historia desde 2 años antes de su inclusión en el estudio como mínimo. En caso contrario debe utilizar un método anticonceptivo adecuado.
E.4Principal exclusion criteria
Pacientes retirados del estudio P04501 a causa de un acontecimiento adverso grave (AAG).
Pacientes retirados del estudio P04501 por elevación de las cifras de las PFH.
Pacientes con cifras de alguno de los parámetros hepáticos por encima del límite superior de normalidad (LSN) en la visita 1: alanina-aminotransferasa (ALT o GPT), aspartato-aminotransferasa (AST o GOT), γ-glutamil transferasa (GGT), fosfatasa alcalina (F Alc) o bilirrubina total (Bil T).
Se excluirá a pacientes con cualquier tipo de parkinsonismo medicamentoso o atípico, deterioro cognitivo o antecedentes de depresión mayor diagnosticada según el DSM IV o depresión o psicosis leve inestable y a los que tomen tolcapona (se podrá incluir a aquellos pacientes con depresión leve bien controlada que reciban dosis estables de un antidepresivo desde 4 semanas antes de la selección como mínimo).
Consumo medio diario de más de dos vasos de vino de 120 ml o su equivalente.
Hipertensión (TA sistólica ≥160 mm Hg O diastólica ≥90 mm Hg).
Pacientes que hayan recibido algún tratamiento no permitido con fármacos potencialmente hepatotóxicos (véase la sección 7.4.2.1.1) durante el periodo de reposo farmacológico indicado antes de la visita 1 o pacientes que tengan que continuar alguno de los tratamientos indicados en la Tabla.
Mujeres en periodo de lactancia o que estén valorando la posibilidad de lactar
E.5 End points
E.5.1Primary end point(s)
No hay una variable principal de eficacia. La variable principal de seguridad es la proporción de pacientes que refieren acontecimientos adversos durante 36 semanas de tratamiento abierto.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis Information not present in EudraCT
E.6.2Prophylaxis Information not present in EudraCT
E.6.3Therapy Information not present in EudraCT
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Information not present in EudraCT
E.6.7Pharmacodynamic Information not present in EudraCT
E.6.8Bioequivalence Information not present in EudraCT
E.6.9Dose response Information not present in EudraCT
E.6.10Pharmacogenetic Information not present in EudraCT
E.6.11Pharmacogenomic Information not present in EudraCT
E.6.12Pharmacoeconomic Information not present in EudraCT
E.6.13Others Information not present in EudraCT
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) 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 No
E.8.1.2Open Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
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 No
E.8.2.3Other No
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 No
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA8
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 years
E.8.9.1In the Member State concerned months
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial months11
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.1.3Elderly (>=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 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 state10
F.4.2 For a multinational trial
F.4.2.1In the EEA 64
F.4.2.2In the whole clinical trial 200
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 Decision2007-12-21
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2007-07-07
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2009-11-19

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