E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Parkinson's Disease |
Enfermedad de Parkinson |
|
E.1.1.1 | Medical condition in easily understood language |
Parkinson's Disease |
Enfermedad de Parkinson |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10034005 |
E.1.2 | Term | Parkinson's disease and parkinsonism |
E.1.2 | System Organ Class | 100000004852 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the long-term clinical benefit and safety of AP-CD/LD in subjects with advanced PD who completed the core study IN 11 004. |
Determinar el beneficio clínico a largo plazo y la seguridad terapéutica de AP-CD/LD en pacientes con EP avanzada que hayan completado el estudio principal IN 11 004. |
|
E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Men or women with PD and who successfully completed the core study IN 11 004 2. Subjects for whom, in the opinion of the Investigator, the PD diagnosis is still valid and subjects remain eligible for LD therapy 3. Subjects able to understand and sign written informed consent to participate in the study |
1. Hombres o mujeres con EP que hayan completado correctamente el estudio principal IN 11 004 2. Pacientes para quienes, en opinión del investigador, el diagnóstico de EP siga siendo válido y continúen siendo idóneos para el tratamiento con LD 3. Pacientes capaces de entender y firmar un consentimiento informado por escrito para participar en el estudio |
|
E.4 | Principal exclusion criteria |
1. Participation in another clinical trial and receipt of an investigational medication within 28 days prior to the planned start of treatment (prior participation in IN 11 004 clinical trial is required) 2. Previous or planned functional neurosurgical treatment for PD (e.g., procedures including ablation or deep brain stimulation) during study participation 3. Concomitant non-steroidal anti-inflammatory drugs (NSAID?s) and oral steroids within 90 days prior to Baseline Visit or planned concomitant administration during study participation 4. Non-selective monoamine oxidase (MAO) inhibitors within 28 days prior to Baseline Visit or planned administration during study participation. 5. Catechol-O-methyltransferase (COMT) inhibitors within 14 days prior to Baseline Visit or planned administration during study participation 6. Opioids within 7 days prior to Baseline Visit or planned administration during study participation 7. In the opinion of the Investigator, subject should not participate in the study |
1. Participación en otro ensayo clínico y recepción de un medicamento en investigación dentro de los 28 días anteriores al inicio planeado del tratamiento (se requiere la participación previa en el ensayo clínico IN 11 004) 2. Antecedentes o planificación de tratamiento neuroquirúrgico funcional para EP (p. e., procedimientos que incluyan ablación o estimulación cerebral profunda) durante la participación en el estudio 3. Uso concomitante de fármacos antinflamatorios no esteroideos (AINE) y corticosteroides orales en los 90 días anteriores a la visita de referencia o planificación de administración concomitante durante la participación en el estudio. 4. Inhibidores no selectivos de la monoamino oxidasa (MAO) en los 28 días anteriores a la visita de referencia o administración planificada durante la participación en el estudio. 5. Inhibidores de la catecol-o-metiltransferasa (COMT) en los 14 días anteriores a la visita de referencia o administración planificada durante la participación en el estudio. 6. Opioides en los 7 días anteriores a la visita de referencia o administración planificada durante la participación en el estudio. 7. En opinión del investigador, el paciente no debe participar en el estudio |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1. Change from Baseline to End of Study (Week 53) in Unified Parkinson's Disease Rating Scale (UPDRS) scale (with Part III to be evaluated in on state. 2. Change from baseline to End of Study in Parkinson?s disease Questionnaire-39 items (PDQ-39). 3. Improvement as recorded on Clinical Global Impression-Improvement (CGI-I) scale-patient and physician |
1. Cambio desde la referencia hasta el final del estudio (semana 53) en la Escala de valoración unificada de la enfermedad de Parkinson (UPDRS) (con la parte III evaluada en estado de conexión. 2. Cambio desde la referencia hasta el final del estudio en el Cuestionario de enfermedad de Parkinson: 39 elementos (PDQ-39). 3. Mejora registrada en la escala de Impresión clínica global-mejora (CGI-I)-paciente y médico. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
End of Study (Week 53) |
Fin de ensayo (semana 53) |
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E.5.2 | Secondary end point(s) |
Safety and Tolerability Outcome Measures 1. Adverse Events 2. Safety laboratory 3. Vital signs 4. Electrocardiogram (ECG) 5. Physical examination 6. Orthostatic hypotension evaluation 7. Withdrawal rates, days and reason to withdrawals |
Criterios de valoración de la seguridad terapéutica y la tolerabilidad 1. Acontecimientos adversos 2. Pruebas analíticas de seguridad terapéutica 3. Constantes vitales 4. Electrocardiograma (ECG) 5. Exploración física 6. Evaluación de la hipotensión ortostática 7. Índices de retirada, días y motivo de las mismas |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
On an ongoing basis. |
A lo largo del ensayo. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | 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 | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 13 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 74 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Bulgaria |
Germany |
Hungary |
Israel |
Italy |
Poland |
Russian Federation |
Slovakia |
Spain |
Ukraine |
United Kingdom |
United States |
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E.8.7 | Trial 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 paciente. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 6 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 18 |