Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04677972
Status:
COMPLETED
Last Update Posted:
2023-11-21
First Post:
2020-06-08
Brief Title:
SPI-1005 for the Treatment of Menieres Disease
Sponsor:
Sound Pharmaceuticals Incorporated
Organization:
Sound Pharmaceuticals Incorporated
Study Overview
Official Title:
A Phase 3 Randomized Double-Blind Placebo-Controlled Multi-Center Study to Evaluate the Safety and Efficacy of SPI-1005 in Menieres Disease and Open Label Extension Study to Evaluate the Chronic Safety of SPI-1005
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STOPMD-3
Brief Summary:
The study is a randomized double-blind placebo-controlled multi-center clinical trial RCT with open-label extension study OLE of SPI-1005 in adult subjects with definite Menieres disease with active symptoms within three months preceding study enrollment
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