E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Parkinson's Disease |
Enfermedad de Parkinson |
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E.1.1.1 | Medical condition in easily understood language |
Parkinson's Disease |
Enfermedad de Parkinson |
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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 | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061536 |
E.1.2 | Term | Parkinson's disease |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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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 assess the local and systemic safety and tolerability of ABBV-951 delivered as a CSCI for 24 hours daily for up to 52 weeks. |
Evaluar la seguridad local y sistémica y la tolerabilidad de ABBV-951 administrado diariamente mediante ISCC de 24 horas de duración durante un máximo de 52 semanas. |
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E.2.2 | Secondary objectives of the trial |
To assess the efficacy of ABBV-951 as measured by patient-reported and rater-measured efficacy endpoints. |
Evaluar la eficacia de ABBV-951 mediante criterios de evaluación comunicados por el paciente y valorados por un evaluador. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adult male or female subjects, 30 years of age or older at the time of screening, with a diagnosis of idiopathic PD that is levodopa-responsive. |
Hombres y mujeres adultos, de, al menos, 30 años de edad en el momento de la selección, con un diagnóstico de Enfermedad de Parkinson Idiopática que responda a Levodopa. |
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E.4 | Principal exclusion criteria |
Subjects judged by the investigator to be adequately controlled by current therapy, that don't have recognizable/identifiable "Off" and "On" states (motor fluctuations), and have less than 2.5 hours of "Off" time per day. |
Sujetos evaluados por el investigador como adecuadamente controlados con la terapia actual, que no tienen estados “ON” y “OFF” reconocibles/identificados (fluctuaciones motoras), y que están menos de 2.5 horas al día en estado “OFF”. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Percentage of subjects with adverse events (AEs) and serious adverse events (SAEs) during the study 2. Percentage of subjects with AEs of special interest (AESI) during the study 3. Percentage of subjects with numeric grade equal to or higher than 5 and percentage of subjects with letter grade equal to or higher than D on the Infusion Site Evaluation Scale at any time during the study 4. Change in clinical laboratory test data from Baseline to end of study 5. Change in vital sign measurements from Baseline to end of study 6. Change in electrocardiograms (ECGs) from Baseline to end of study |
1. Porcentaje de sujetos con eventos adversos (AEs) y eventos adversos serios (SAEs) durante el estudio. 2. Porcentaje de sujetos con AEs de especial interés (AESI) durante el estudio. 3. Porcentaje de sujetos con una valoración numérica igual o mayor que 5 y proporción de sujetos con una valoración alfabética igual o superior a D en la Escala de Evaluación del Sitio de Infusión en cualquier momento del estudio. 4. Cambios en análisis de laboratorio desde la visita Basal hasta el final del estudio. 5. Cambios en las medidas de signos vitales desde la visita Basal hasta el final de estudio. 6. Cambios en Electrocardiograma (ECG) desde la visita Basal hasta el final de estudio. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Screening Visit 1, Enrollment Day 1, Day 2, Week 1, Week 2, Week 3, Week 4, Week 6, Week 13, Week 26, Week 39, Week 52/Premature Discontinuation, Unscheduled visits. 2. Screening Visit 1, Enrollment Day 1, Day 2, Week 1, Week 2, Week 3, Week 4, Week 6, Week 13, Week 26, Week 39, Week 52/Premature Discontinuation, Unscheduled visits. 3. Enrollment Day 1, Day 2, Week 1, Week 2, Week 3, Week 4, Week 6, Week 13, Week 26, Week 39, Week 52/Premature Discontinuation, Unscheduled visits. 4. Enrollment Day 1, Week 6, Week 26, Week 39, Week 52/Premature Discontinuation. 5. Enrollment Day 1, Day 2, Week 1, Week 2, Week 3, Week 4, Week 6, Week 13, Week 26, Week 39, Week 52/Premature Discontinuation, Unscheduled visits. 6. Enrollment Day 1, Week 6, Week 52/Premature Discontinuation. |
1. Visita selección 1, Inclusión Día 1, Día 2, Sem 1, Sem 2, Sem 3, Sem 4, Sem 6, Sem 13, Sem 26, Semana 39, Sem 52/Discontinuación Prematura, Visitas No Programadas. 2. Visita selección 1, Inclusión Día 1, Día 2, Sem 1, Semana 2, Semana 3, Semana 4, Semana 6, Semana 13, Semana 26, Semana 39, Semana 52/Discontinuación Prematura, Visitas No Programadas. 3. Inclusión Día 1, Día 2, Sem 1, Sem 2, Sem 3, Sem 4, Sem 6, Sem 13, Sem 26, Sem 39, Sem 52/Discontinuación Prematura, Visitas No Programadas. 4. Inclusión Día 1, Sem 6, Sem 26, Sem 39, Sem 52/Discontinuación Prematura. 5. Inclusión Día 1, Día 2, Sem 1, Sem 2, Sem 3, Sem 4, Sem 6, Sem 13, Sem 26, Sem 39, Sem 52/Discontinuación Prematura, Visitas No Programadas. 6. Inclusión Día 1, Sem 6, Sem 52/Discontinuación Prematura. |
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E.5.2 | Secondary end point(s) |
Change from Baseline to end of study for the following: 1. Average normalized daily "Off" time and "On" times as assessed by the PD Diary 2. PD symptoms as assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-IV (or the UPDRS Parts I-V in countries where a validated translation of the MDS-UPDRS is not available) 3. Sleep symptoms as assessed by the PD Sleep Scale-2 (PDSS-2) 4. Quality of life as assessed by the PD Questionnaire-39 items (PDQ-39) 5. Health-related quality of life as assessed by the EuroQol 5-dimensions questionnaire (EQ-5D-5L) |
Cambio desde la visita Basal hasta el final del estudio en los siguientes aspectos: 1. Tiempos medios normalizados diarios en estados “OFF” y “ON” evaluados por el Diario de EP. 2. Síntomas EP evaluados por las Partes I-IV de la Escala unificada de valoración de la Enfermedad de Parkinson de la Movement Disorder Society (MDS-UPDRS)(o las Partes I-IV de la UPDRS en países donde la traducción validada de la MDS-UPDRS no esté disponible). 3. Síntomas de EP evaluados por la Escala de Sueño de EP 2 (PDSS-2). 4. Calidad de vida evaluada por el Cuestionario para EP de 39 apartados (PDQ-39) 5. Calidad de vida relacionada con la salud evaluada por el Cuestionario EuroQol de 5 dimensiones (EQ-5D-5L) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Enrollment Day 1 (V3), Week 1 (V5), Week 6 (V9), Week 26 (V11), Week 39 (V12), Week 52 (V13)/Premature Discontinuation 2. Enrollment Day 1 (V3), Day 2 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), Week 4 (V8), Week 6 (V9), Week 13 (V10), Week 26 (V11), Week 39 (V12), Week 52 (V13)/Premature Discontinuation 3. Enrollment Day 1 (V3), Week 6 (V9), Week 13 (V10), Week 26 (V11), Week 39 (V12), Week 52 (V13)/Premature Discontinuation 4. Enrollment Day 1 (V3), Week 6 (V9), Week 13 (V10), Week 26 (V11), Week 39 (V12), Week 52 (V13)/Premature Discontinuation 5. Enrollment Day 1 (V3), Week 6 (V9), Week 13 (V10), Week 26 (V11), Week 39 (V12), Week 52 (V13)/Premature Discontinuation |
1. Día 1 de Inclusión (V3), Semana 1 (V5), Semana 6 (V9), Semana 26 (V11), Semana 39 (V12), Semana 52 (V13)/Discontinuación Prematura. 2. Día 1 de Inclusión (V3), Día 2 (V4), Semana 1 (V5), Semana 2 (V6), Semana 3 (V7), Semana 4 (V8), Semana 6 (V9), Semana 13 (V10), Semana 26 (V11), Semana 39 (V12), Semana 52 (V13)/Discontinuación Prematura. 3. Día 1 de Inclusión (V3), Semana 6 (V9), Semana 13 (V10), Semana 26 (V11), Semana 39 (V12), Semana 52 (V13)/Discontinuación Prematura. 4. Día 1 de Inclusión (V3), Semana 6 (V9), Semana 13 (V10), Semana 26 (V11), Semana 39 (V12), Semana 52 (V13)/Discontinuación Prematura. 5. Día 1 de Inclusión (V3), Semana 6 (V9), Semana 13 (V10), Semana 26 (V11), Semana 39 (V12), Semana 52 (V13)/Discontinuación Prematura. |
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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 | No |
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 | Yes |
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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 28 |
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 |
Australia |
Canada |
Japan |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
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 |