E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute ischemic stroke |
Ictus isquémico agudo |
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E.1.1.1 | Medical condition in easily understood language |
Blockage of blood vessels in the brain resulting in damage to brain. |
Bloqueo de vasos sanguíneos en el cerebro, causante de daño cerebral. |
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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 | 22.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061256 |
E.1.2 | Term | Ischaemic stroke |
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 |
Evaluate the efficacy of MultiStem on functional outcome in subjects with ischemic stroke. |
Evaluar la eficacia de MultiStem en el resultado funcional en pacientes con ictus isquémico. |
|
E.2.2 | Secondary objectives of the trial |
- To evaluate the efficacy of MultiStem on functional, neurological, mortality, secondary infection, and hospitalization outcomes in subjects with ischemic stroke; and - To evaluate the safety of MultiStem in subjects with ischemic stroke. |
- Evaluar la eficacia de MultiStem sobre variables funcionales, neurológicas, de mortalidad, de infección secundaria y de hospitalización en pacientes con ictus isquémico; y - Evaluar la seguridad de MultiStem en pacientes con ictus isquémico. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Male or female subjects ≥18 years of age •Clinical diagnosis of ischemic stroke involving cerebral cortex •Occurrence of a moderate to moderately severe stroke with a persistent neurologic deficit documented by a NIHSS score of 8 to 20 (inclusive) that does not change by ≥4 points during the initial screening period •A mRS score of 0 or 1 prior to the onset of symptoms of the current stroke |
•Varones o mujeres mayores de 18 años •Diagnóstico clínico de ictus isquémico con afectación de la corteza cerebral •Aparición de un ictus moderado o moderadamente grave con un déficit neurológico persistente documentado mediante una puntuación de 8 a 20 (inclusive) en la Escala de ictus de los Institutos Nacionales de Salud de EE. UU. (National Institutes of Health Stroke Scale - NIHSS) que no varíe en ≥4 puntos durante el periodo de selección inicial •Puntuación en la Escala de Rankin modificada (mRS) de 0 o 1 antes de la aparición de los síntomas del ictus actual |
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E.4 | Principal exclusion criteria |
•Presence of a lacunar or a brainstem infarct •Comatose state •Brain hemorrhage •Major neurological event such as stroke or clinically significant head trauma within 6 months of enrollment into the study |
•Presencia de un infarto lagunar o del tronco encefálico •Coma •Hemorragia cerebral •Episodio neurológico importante, como ictus o traumatismo craneoencefálico clínicamente significativo, en los 6 meses previos a la incorporación al estudio |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1.proportion of subjects achieving an excellent functional outcome at Day 365 defined by all of the following criteria: mRS score = 0 to 1 [scale range 0 to 6]; and NIHSS score = 0 to 1 [scale range 0 to 42]; and Barthel Index score = greater than or equal to 95 [scale range 0 to 100] 2.proportion of subjects achieving an excellent functional outcome at Day 90 defined by all of the following criteria: mRS score = 0 to 1 [scale range 0 to 6]; and NIHSS score = 0 to 1 [scale range 0 to 42]; and Barthel Index score = greater than or equal to 95 [scale range 0 to 100] 3.proportion of subjects with a mRS score of less than or equal to 2 [scale range 0 to 6] demonstrating the ability to function independently at Day 90 |
1.Proporción de sujetos que alcanzan un resultado funcional excelente al día 365 definido por la totalidad de los siguientes criterios: puntuación mRS = 0 a 1 [rango de la escala 0 a 6]; y puntuación NIHSS = 0 a 1 [rango de la escala 0 a 42]; puntuación del Índice de Barthel = mayor o igual a 95 [rango de la escala 0 a 100]; 2.Proporción de sujetos que alcanzan un resultado funcional excelente al día 90 definido por la totalidad de los siguientes criterios: puntuación mRS = 0 a 1 [rango de la escala 0 a 6]; y puntuación NIHSS = 0 a 1 [rango de la escala 0 a 42]; puntuación del Índice de Barthel = mayor o igual a 95 [rango de la escala 0 a 100]; 3.Proporción de sujetos con una puntuación mRS menor o igual a 2 [rango de la escala 0 a 6] que demuestra la capacidad de funcionar en forma independiente al día 90 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. 365 days 2. 90 days 3. 90 days |
1. 365 días 2. 90 días 3. 90 días |
|
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
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 |
United States |
Netherlands |
Spain |
Germany |
Portugal |
United Kingdom |
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E.8.7 | Trial 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
|
LVLS |
Última visita del último paciente |
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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 | 11 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 5 |