Ignite Creation Date:
2024-05-06 @ 7:59 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02647359
Status:
COMPLETED
Last Update Posted:
2022-05-27
First Post:
2015-12-29
Brief Title:
Study of Ataluren in Participants With Nonsense Mutation Aniridia
Sponsor:
PTC Therapeutics
Organization:
PTC Therapeutics
Study Overview
Official Title:
A Phase 2 Multicenter Randomized Double-Masked Placebo-Controlled Study of the Safety and Efficacy of Ataluren PTC124 for the Treatment of Nonsense Mutation Aniridia
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR
Brief Summary:
This 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None