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natalizumab · ASCEND in SPMS
A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Participants With Secondary Progressive Multiple Sclerosis
Ensayo de BIOGEN INC. en Esclerosis multiple secundaria progresiva.
- Fase
- Fase 3
- Estado
- Interrumpido
- Participantes
- 889
- Centros
- 161
- Fin del objetivo primario
- jul 2015
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, triple ciego. Comenzó en sep 2011.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «The ASCEND Study did not achieve statistical significance on the primary or secondary endpoints.».
Qué mide
Parte 1: Porcentaje de participantes con progresion confirmada de la discapacidad en una o mas de la Escala Expandida del Estado de Discapacidad (EDSS), la Prueba de Marcha Cronometrada de 25 Pies (T25FW), o la Prueba de Clavijas de 9 Agujeros (9HPT) (Up to 96 weeks (2 years)) (del registro, en inglés)
Qué se prueba
Se investiga si natalizumab ralentiza la acumulación de discapacidad no relacionada con recaídas en participantes con esclerosis múltiple progresiva secundaria, y se evalúan cambios en movilidad, capacidad manual, calidad de vida y volumen cerebral medido por resonancia magnética.
Lo que dice el documentoThe primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in participants with secondary progressive multiple sclerosis (SPMS). The secondary objectives of Part 1 of this study are to determine the proportion of participants with consistent improvement in Timed 25-Foot Walk (T25FW), the change in participant-reported ambulatory status as measured by the 12-item MS Walking Scale (MSWS-12), the change in manual ability based on the ABILHAND Questionnaire, the impact of natalizumab on participant-reported quality of life using the Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical), the change in whole brain volume between the end of study and Week 24 using magnetic resonance imaging (MRI) and the proportion of participants experiencing progression of disability as measured by individual physical Expanded Disability Status Scale (EDSS) system scores.
Traducción automática (claude-haiku-4-5-20251001). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis is a Phase 3b, multicenter, international study conducted in 2 parts. Upon completion of the placebo-controlled period (Part 1), participants will have the option of enrolling in a 2-year open-label extension (Part 2). Part 1: The primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in participants with secondary progressive multiple sclerosis (SPMS). The secondary objectives of Part 1 of this study are to determine the proportion of participants with consistent improvement in Timed 25-Foot Walk (T25FW), the change in participant-reported ambulatory status as measured by the 12-item MS Walking Scale (MSWS-12), the change in manual ability based on the ABILHAND Questionnaire, the impact of natalizumab on participant-reported quality of life using the Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical), the change in whole brain volume between the end of study and Week 24 using magnetic resonance imaging (MRI) and the proportion of participants experiencing progression of disability as measured by individual physical Expanded Disability Status Scale (EDSS) system scores. Part 2: The primary objective of Part 2 of the study is to evaluate the safety profile of natalizumab in participants with SPMS. The secondary objectives of Part 2 of the study are to investigate long-term disability (based on clinical or participant-reported assessments) in participants with SPMS receiving natalizumab treatment for approximately 4 years and to assess change in brain volume and T2 lesion volume.
Más ensayos de BIIB
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Diranersen · CELIA | Fase 2 | En marcha, sin reclutar | mar 2026 (real) |
| BIIB142 | Fase 1 | Reclutando pacientes | ago 2026 (prevista, ya pasada: sin actualizar en el registro) |
| Litifilimab · TOPAZ-2 | Fase 3 | En marcha, sin reclutar | sep 2026 (prevista, ya pasada: sin actualizar en el registro) |
| Litifilimab · TOPAZ-1 | Fase 3 | En marcha, sin reclutar | sep 2026 (prevista, ya pasada: sin actualizar en el registro) |
| Litifilimab · AMETHYST | Fase 2/3 | En marcha, sin reclutar | oct 2026 (prevista) |
| Natalizumab | no aplica | En marcha, sin reclutar | oct 2026 (prevista) |
Todos los de BIIB, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01416181), actualizada en ago 2017.