Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05753852
Status:
RECRUITING
Last Update Posted:
2023-03-03
First Post:
2023-02-23
Brief Title:
Open Label Extension of TUDCA-ALS Study
Sponsor:
Humanitas Mirasole SpA
Organization:
Humanitas Mirasole SpA
Study Overview
Official Title:
Open Label Extension Study to Investigate Long Term Safety Tolerability and Efficacy of Tauroursodeoxycholic Acid in Patients With ALS Who Completed the TUDCA-ALS Study
Status:
RECRUITING
Status Verified Date:
2023-02
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:
TUDCA-ALS OLE
Brief Summary:
This study will provide extended access to patients and assess longer-term outcomes on patients who have completed the TUDCA-ALS study
Detailed Description:
The TUDCA-ALS Open label extension study is designed to investigate long term safety tolerability and efficacy of tauroursodeoxycholic acid in patients with ALS who completed the TUDCA-ALS 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