Ignite Creation Date:
2024-05-06 @ 12:57 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03896945
Status:
TERMINATED
Last Update Posted:
2024-05-24
First Post:
2019-03-19
Brief Title:
Efficacy Safety and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia
Sponsor:
Otsuka Pharmaceutical Development Commercialization Inc
Organization:
Otsuka Pharmaceutical Development Commercialization Inc
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Parallel-arm Study to Assess the Efficacy Safety and Tolerability of AVP-786 Deudextromethorphan Hydrobromide d6-DMQuinidine Sulfate Q for the Treatment of Negative Symptoms of Schizophrenia
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Based on the Interim Analysis outcome and recommendation by the DMC Otsuka approved termination of the study based on futility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will be conducted to evaluate the efficacy safety and tolerability of AVP-786 as compared with placebo for the treatment of negative symptoms of schizophrenia
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-001352-33 | EUDRACT_NUMBER | None | None |