Ignite Creation Date:
2024-05-06 @ 2:59 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04480476
Status:
WITHDRAWN
Last Update Posted:
2021-11-01
First Post:
2020-07-10
Brief Title:
A Retrospective Natural History Study in Children With CLN2
Sponsor:
REGENXBIO Inc
Organization:
REGENXBIO Inc
Study Overview
Official Title:
A Retrospective Chart Review Study to Evaluate Ocular Disease Progression in Children With Late-infantile Neuronal Ceroid Lipofuscinosis Type 2 CLN2
Status:
WITHDRAWN
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study stopped due to company decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi center retrospective chart review study to document the evolution of ocular disease progression in pediatric patients with CLN2
Detailed Description:
CLN2 is a rare disease with limited available ocular natural history data While current standard of care slows motor degeneration it is not known to treat the ocular manifestations of disease This study is planned to document through retrospective data collection ocular disease progression in children with a clinical presentation consistent with CLN2 No investigational product is administered in this retrospective chart review study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None