Ignite Creation Date:
2024-05-06 @ 2:55 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04464564
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2020-07-06
Brief Title:
Study to Assess the Efficacy Safety and Tolerability of AVP-786 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 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:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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 deudextromethorphan hydrobromide d6-DMquinidine sulfate Q 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 study consisting of 12 weeks of treatment
Approximately 750 participants will be enrolled at approximately 110 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 study consisting of 12 weeks of treatment
Approximately 750 participants will be enrolled at approximately 110 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 |
|---|---|---|---|
| 2020-000799-39 | EUDRACT_NUMBER | None | None |