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Ataluren · STAR

Study of Ataluren in Participants With Nonsense Mutation Aniridia

Ensayo de PTC THERAPEUTICS, INC. en Aniridia (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

39

previstos

Centros

3

Fin del objetivo primario

ene 2021

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en ene 2016.

Qué mide

Percent Change From Baseline in Maximum Reading Speed of Oculus Unitas (OU) (Both Eyes) at Week 48, as Measured Using the Minnesota Low Vision Reading Test (MNREAD) Acuity Charts (del registro, en inglés) (inicio y semana 48)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study is designed to evaluate the effect of ataluren on Maximum Reading Speed as measured using the Minnesota Low Vision Reading Test (MNREAD) Acuity Charts in participants with nonsense mutation aniridia. This study involves a 4-week screening period, a 144-week treatment period (Stage 1: Weeks 1 to 48 \[double-masked treatment\] and Stage 2: Weeks 49 to 144 \[open label treatment\]), an optional 96-week open label extension sub-study, and a 4-week post-treatment follow-up period (either study completion or early termination). Participants that choose not to participate in the sub-study will be required to complete the post-treatment follow-up visit at the end of the Stage 2 open-label extension.

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Ficha completa en ClinicalTrials.gov (NCT02647359), actualizada en may 2022.