E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsing-remitting multiple sclerosis (RRMS) |
Esclerosis múltiple remitente recidivante (EMRR) |
|
E.1.1.1 | Medical condition in easily understood language |
Multiple Sclerosis |
Esclerosis múltiple |
|
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 | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10063399 |
E.1.2 | Term | Relapsing-remitting multiple sclerosis |
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 evaluate the long-term safety and tolerability of MT-1303 in subjects with RRMS |
Evaluar la seguridad y tolerabilidad a largo plazo de MT 1303 en pacientes con EMRR |
|
E.2.2 | Secondary objectives of the trial |
? To evaluate the long-term effects of MT-1303 on magnetic resonance imaging (MRI) parameters, clinical outcomes and health-related quality of life in subjects with RRMS ? To evaluate the pharmacodynamics of MT-1303 in subjects with RRMS |
? Evaluar los efectos a largo plazo de MT 1303 sobre los parámetros de resonancia magnética (RM), los criterios de valoración clínicos y la calidad de vida relacionada con la salud en pacientes con EMRR. ? Evaluar la farmacodinamia de MT 1303 en pacientes con EMRR. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Completion of the 24-week Treatment Period in MT-1303-E04 as per protocol |
Finalización del periodo de tratamiento de 24 semanas del estudio MT 1303 E04 según el protocolo. |
|
E.4 | Principal exclusion criteria |
1. Permanent discontinuation of study medication prior to the End of Treatment (EOT) Visit in MT-1303-E04 2. Newly diagnosed diabetes mellitus during MT-1303-E04 |
1. Suspensión permanente de la medicación del estudio antes de la visita de final del tratamiento (FDT) del estudio MT 1303 E04. 2. Diabetes mellitus recién diagnosticada durante el estudio MT 1303 E04. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety Assessments ? Adverse events (AEs) ? Vital signs ? 12-lead electrocardiogram (ECG) ? 3-lead Holter ECG monitoring ? Routine safety laboratory assessments ? Physical examination ? Optical coherence tomography (OCT) |
Evaluaciones de la seguridad ? Acontecimientos adversos (AA). ? Constantes vitales. ? Electrocardiograma (ECG) de 12 derivaciones. ? Monitorización electrocardiográfica con Holter de 3 derivaciones. ? Evaluaciones analíticas de seguridad habituales. ? Exploración física. ? Tomografía de coherencia óptica (TCO). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Various timepoints throughout the study - please refer to the detailed Time and Events Schedule in the protocol for full details |
Varios momentos durante el estudio - por favor, consulte el calendario detallado y calendario de eventos en el protocolo para obtener más detalles |
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E.5.2 | Secondary end point(s) |
Clinical Efficacy Endpoints: ? Annualised Relapse Rate (ARR) ? Time to first confirmed relapse ? Proportion of subjects who remain relapse-free at End of Treatment (EOT) ? Change from baseline in total Expanded Disability Status Scale (EDSS) score at EOT ? Change from baseline in total Multiple Sclerosis Functional Composite (MSFC) score at EOT
MRI Endpoints: ? Number of MRI Gd-enhanced T1-weighted lesions ? Number and volume of new or enlarged T2-weighted lesions ? Change and percent change in brain volume at EOT ? Magnetisation Transfer Ratio (MTR) related endpoints will be explored. Details to be specified in the Statistical Analysis Plan (SAP) (selected centres only)
Pharmacodynamic Endpoints: ? Lymphocyte counts ? Lymphocyte subsets (selected centres only)
Subject-reported Endpoints: ? Change from baseline in MSQOL-54 at EOT. |
Criterios de valoración clínicos ? Tasa anualizada de recidivas (TAR). ? Tiempo transcurrido hasta la primera recidiva confirmada. ? Proporción de pacientes que permanezcan sin recidivas al fin de tratamiento (FDT). ? Variación con respecto al momento basal de la puntuación EDSS (Escala ampliada del estado de discapacidad) total al FDT.
Criterios de valoración basados en la RM ? Número de lesiones ponderadas en T1 con captación de gadolinio en la RM. ? Número y volumen de lesiones ponderadas en T2 nuevas o que hayan aumentado de tamaño. ? Variación y variación porcentual del volumen cerebral al FDT. ? Criterios de valoración relacionados con el índice de transferencia de magnetización (ITM) indicados en el plan de análisis estadístico (PAE) (únicamente en centros seleccionados). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Various timepoints throughout the study - please refer to the detailed Time and Events Schedule in the protocol for full details |
Varios momentos durante el estudio - por favor, consulte el calendario detallado y calendario de eventos en el protocolo para obtener más detalles |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 |
Tolerability |
Tolerabilidad |
|
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
This study is a parallel group 2 part study. Part 1 of the study is double-blind and Part 2 of the s |
|
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 | 3 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 63 |
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 |
Belgium |
Bosnia and Herzegovina |
Bulgaria |
Canada |
Croatia |
Czech Republic |
Finland |
Germany |
Hungary |
Italy |
Latvia |
Lithuania |
Poland |
Russian Federation |
Serbia |
Spain |
Sweden |
Switzerland |
Turkey |
Ukraine |
United Kingdom |
|
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
|
LSLV |
Última visita, último paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 2 |