Ignite Creation Date:
2024-05-06 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03095066
Status:
COMPLETED
Last Update Posted:
2023-09-29
First Post:
2017-03-23
Brief Title:
Study to Assess the Efficacy Safety and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression Agitation and Irritability in Participants With Traumatic Brain Injury
Sponsor:
Otsuka Pharmaceutical Development Commercialization Inc
Organization:
Otsuka Pharmaceutical Development Commercialization Inc
Study Overview
Official Title:
A Phase 2 Multicenter Randomized Double-blind Placebo-controlled Study to Assess the Efficacy Safety and Tolerability of AVP-786 Deudextromethorphan Hydrobromide d6-DMQuinidine Sulfate Q for the Treatment of Neurobehavioral Disinhibition Including Aggression Agitation and Irritability in Patients With Traumatic Brain Injury TBI
Status:
COMPLETED
Status Verified Date:
2023-09
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:
This is a multicenter randomized placebo-controlled study to evaluate AVP-786 for the treatment of neurobehavioral disinhibition including aggression agitation and irritability in participants with traumatic brain injury TBI
Detailed Description:
Eligible participants for this study must have a diagnosis of neurobehavioral disinhibition including aggression agitation and irritability that persists after brain injury
This is a multicenter randomized placebo-controlled study consisting of up to 12 weeks of treatment
This is a multicenter randomized placebo-controlled study consisting of up to 12 weeks of treatment
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