Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-27 @ 11:19 AM
Study NCT ID:
NCT04988867
Status:
TERMINATED
Last Update Posted:
2024-09-24
First Post:
2021-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Open-Label Study of Trofinetide for the Treatment of Girls Two to Five Years of Age Who Have Rett Syndrome
Sponsor:
ACADIA Pharmaceuticals Inc.
Organization:
Study Overview
Official Title:
An Open-Label Study of Trofinetide for the Treatment of Girls Two to Five Years of Age Who Have 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:
DAFFODIL™
Brief Summary:
To investigate the safety and tolerability of long-term treatment with oral trofinetide in girls with Rett syndrome
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: