Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04776746
Status:
TERMINATED
Last Update Posted:
2023-08-01
First Post:
2020-11-29
Brief Title:
Open-Label Extension Study of Trofinetide for Rett Syndrome
Sponsor:
ACADIA Pharmaceuticals Inc
Organization:
ACADIA Pharmaceuticals Inc
Study Overview
Official Title:
An Open-Label Extension Study of Continuing Treatment With Trofinetide for Rett Syndrome
Status:
TERMINATED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
As a result of marketing approval of trofinetide on 10 March 2023 the study was terminated by the Sponsor with the intent of switching patients to commercially available product
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To investigate the safety and tolerability of continued long-term treatment with oral trofinetide in girls and women with Rett syndrome
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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