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Methodology Study of Novel Outcome Measures to Assess Progression of ALS
Ensayo de BIOGEN INC. en Esclerosis lateral amiotrofica.
Más ensayos de: Esclerosis lateral amiotrófica.
- Fase
- no aplica
- Estado
- Completado
- Participantes
- 138
- Centros
- 21
- Fin del objetivo primario
- jul 2018
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio observacional. Comenzó en ene 2016.
Qué mide
Longitudinal standardized mean change in electrophysiological measures as assessed by electrical impedance myography (EIM) (Baseline to Month 6 and Baseline to Month 12) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe primary objectives of the study are to estimate and rank-order the longitudinal standardized mean changes over 6 months and over 12 months, for a set of outcome measures administered to participants with amyotrophic lateral sclerosis (ALS), in order to identify measures that are more sensitive to disease progression than Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R). The secondary objectives of this study are: To evaluate the test-retest reproducibility of each outcome measure; To determine correlations between 6 and 12-month changes in all exploratory measures with 18 and 24-month changes in ALSFRS-R and survival; To assess correlations between/among the various measures; To obtain biological samples in order to identify molecular correlates to the clinical measures and to further characterize previously identified and novel molecular biomarkers of disease progression for incorporation into future clinical studies.
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 (NCT02611674), actualizada en oct 2019.