Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-03-01 @ 1:45 PM
Study NCT ID:
NCT03110458
Status:
COMPLETED
Last Update Posted:
2020-10-27
First Post:
2017-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of SENS-111 in Patients Suffering From Acute Unilateral Vestibulopathy
Sponsor:
Sensorion
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 2 Dose Regimens of Orally Administered SENS-111 (100 mg and 200 mg) Given During 4 Days in Patients Suffering From Acute Unilateral Vestibulopathy
Status:
COMPLETED
Status Verified Date:
2020-10
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:
None
Brief Summary:
A multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 2 dose-regimens of orally administered SENS-111 (100mg and 200mg) given during 4 days in patients suffering from Acute Unilateral Vestibulopathy (AUV)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: