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BIIB092 · PASSPORT

Study of BIIB092 in Participants With Progressive Supranuclear Palsy

Ensayo de BIOGEN INC. en Supranuclear Palsy, Progressive (del registro, en inglés).

Fase

Fase 2

Estado

Interrumpido

Participantes

490

previstos

Centros

86

Fin del objetivo primario

sep 2019

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en jun 2017.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «251PP301(PASSPORT) primary endpoint was not met;Biogen decision to close the study early. There were no safety concerns with the PASSPORT study.».

Qué mide

Change From Baseline in Progressive Supranuclear Palsy Rating Scale (PSPRS) at Week 52 (del registro, en inglés) (inicio y semana 52)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe Primary objective of the study is to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change from baseline in the PSP Rating Scale (PSPRS) at Week 52 and to assess the safety and tolerability of BIIB092, relative to placebo, by measuring the frequency of deaths, SAEs, AEs leading to discontinuation, and Grade 3 \& 4 laboratory abnormalities. The Secondary objective of the study is to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change in baseline in the Movement Disorder Society (MDS)-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II at Week 52, to evaluate the efficacy of BIIB092, compared to placebo, as measured by the Clinical Global Impression of Change (CGI-C) at Week 52, to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change in baseline in the Repeatable Battery for the Assessment of Neuropsychological Disease Severity (RBANS) at Week 52 and to assess the impact of BIIB092 on quality of life, relative to placebo, as measured by change from baseline on the Progressive Supranuclear Palsy Quality of Life scale (PSP-QoL) at Week 52.

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Todos los de BIIB, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03068468), actualizada en nov 2020.