Ignite Creation Date:
2024-05-06 @ 10:56 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03393520
Status:
COMPLETED
Last Update Posted:
2024-04-04
First Post:
2018-01-03
Brief Title:
Assessment of the Efficacy Safety and Tolerability of AVP-786 Deudextromethorphan Hydrobromide d6-DMQuinidine Sulfate Q for the Treatment of Agitation in Patients With Dementia of the Alzheimers Type
Sponsor:
Otsuka Pharmaceutical Development Commercialization Inc
Organization:
Otsuka Pharmaceutical Development Commercialization Inc
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Double-blind Placebo-controlled Parallel-design Study to Assess the Efficacy Safety and Tolerability of AVP-786 Deudextromethorphan Hydrobromide d6-DMQuinidine Sulfate Q for the Treatment of Agitation in Patients With Dementia of the Alzheimers Type
Status:
COMPLETED
Status Verified Date:
2023-08
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 study will be conducted to evaluate the efficacy safety and tolerability of AVP-786 compared to placebo for the treatment of agitation in participants with dementia of the Alzheimers type
Detailed Description:
Eligible participants for this study must have a diagnosis of probable Alzheimers disease AD and must have clinically significant moderatesevere agitation secondary to AD
This is a multicenter randomized double-blind placebo-controlled parallel-design study consisting of 12 weeks of treatment
Approximately 550 participants will be enrolled at approximately 90 centers worldwide
Study medication will be administered orally twice-daily from Day 1 through Day 85 Screening will occur within approximately 4 weeks prior to randomization Following screening procedures for assessment of inclusion and exclusion criteria eligible participants will be randomized into the study
This is a multicenter randomized double-blind placebo-controlled parallel-design study consisting of 12 weeks of treatment
Approximately 550 participants will be enrolled at approximately 90 centers worldwide
Study medication will be administered orally twice-daily from Day 1 through Day 85 Screening will occur within approximately 4 weeks prior to randomization Following screening procedures for assessment of inclusion and exclusion criteria eligible participants will be randomized into the study
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 |
|---|---|---|---|
| 2017-001339-38 | EUDRACT_NUMBER | None | None |