E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsing Remitting Multiple Sclerosis |
Esclerosis múltiple remitente recurrente |
|
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 | 19.0 |
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 |
|
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 |
1) to evaluate the long-term safety and tolerability of ALKS 8700 for up to 96 weeks of treatment in adult subjects with RRMS |
1) evaluar la seguridad y la tolerabilidad a largo plazo de ALKS 8700 durante un máximo de 96 semanas de tratamiento en sujetos adultos con EMRR |
|
E.2.2 | Secondary objectives of the trial |
2) to evaluate treatment effect over time in adult subjects with RRMS treated with ALKS 8700. |
2) evaluar el efecto del tratamiento en el tiempo en sujetos adultos con EMRR tratados con ALKS 8700. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Has a confirmed diagnosis of RRMS - Neurologically stable with no evidence of relapse within 30 days prior to Visit 2 - Additional criteria may apply |
- Diagnóstico confirmado de EMRR - Neurológicamente estables, sin pruebas de recidiva en los 30 días previos a la Visita 2 - Pueden aplicar criterios adicionales |
|
E.4 | Principal exclusion criteria |
- Subject is pregnant or breastfeeding or plans to become pregnant or begin breastfeeding at any point during the study and for 30 days after any study drug administration - Diagnosis of primary progressive secondary progressive, or progressive relapsing MS - History of clinically significant cardiovascular, pulmonary, gastrointestinal (inflammatory bowel disease [IBD]; Crohn's disease, ulcerative colitis), dermatologic, psychiatric, neurologic (other than MS), and/or other major disease that would preclude participation in a clinical trial - History of a myocardial infarction, including a silent myocardial infarction identified on ECG, or unstable angina - Additional criteria may apply |
- La sujeto está embarazada o en período de lactancia o planea quedarse embarazada o comenzar la lactancia en cualquier momento durante el estudio y durante 30 días después de la administración de cualquier fármaco del estudio. - Diagnóstico de EM primaria progresiva, secundaria progresiva o recurrente progresiva - Antecedentes de enfermedad cardiovascular, pulmonar, gastrointestinal (enfermedad inflamatoria intestinal [EII]; enfermedad de Crohn, colitis ulcerosa), dermatológica, psiquiátrica, neurológica (que no sea EM) y/u otras graves que impedirían la participación en un ensayo clínico - Antecedentes de infarto de miocardio, como infarto de miocardio silente identificado en el ECG o angina inestable - Pueden aplicar criterios adicionales |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Safety will be demonstrated by incidence of Adverse Events - All enrolled subjects who receive at least one dose of ALKS 8700 will be used in the safety and tolerability analysis |
- La seguridad se demonstrará por la incidencia de Acontecimientos Adversos - Se emplearán para el análisis de seguridad y tolerabilidad todos los sujetos que hayan recibido al menos una dosis de ALKS 8700 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
various study visits |
varias visitas del estudio |
|
E.5.2 | Secondary end point(s) |
N/A |
Otros criterios de valoración ?SF-12 (puntuación del dominio) ?Puntuaciones en la escala analógica visual EQ-5D-5L |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
N/A |
varias visitas del estudio |
|
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 | No |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 43 |
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 |
Bulgaria |
Canada |
Germany |
Poland |
Russian Federation |
Serbia |
Spain |
Ukraine |
United States |
|
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
|
LPLV |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 7 |
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 | 8 |
E.8.9.2 | In all countries concerned by the trial days | 4 |