Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04644549
Status:
TERMINATED
Last Update Posted:
2022-04-11
First Post:
2020-10-27
Brief Title:
Natural History Study of Batten Disease
Sponsor:
Amicus Therapeutics
Organization:
Amicus Therapeutics
Study Overview
Official Title:
Natural History Study of Batten Disease
Status:
TERMINATED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study terminated following strategic portfolio and RD alignment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter international study to assess the natural history data from people with Batten disease by collecting both retrospective and prospective information about the motor behavioral and functional capabilities of patients The study initially has 2 cohorts Cohort 1 n 75 includes subjects with CLN6 Batten disease Cohort 2 n 120 includes subjects with juvenile CLN3 Batten disease Additional cohorts for other Batten disease subtypes may be added in the future
Detailed Description:
None
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