Ignite Creation Date:
2024-05-06 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03420222
Status:
TERMINATED
Last Update Posted:
2022-05-24
First Post:
2018-01-19
Brief Title:
Study to Assess the Efficacy Safety and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder
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 Intermittent Explosive Disorder IED
Status:
TERMINATED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to limited enrollment N10 this clinical trial was terminated by the Sponsor
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 double-blind placebo-controlled study to evaluate AVP-786 for the treatment of Intermittent Explosive Disorder IED
Detailed Description:
Eligible participants for this study must have a diagnosis of current IED
This is a multicenter randomized double-blind placebo-controlled study consisting of up to 12 weeks of treatment
This is a multicenter randomized double-blind 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