Ignite Creation Date:
2024-05-06 @ 12:28 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01584440
Status:
COMPLETED
Last Update Posted:
2021-11-26
First Post:
2012-04-23
Brief Title:
Efficacy Safety and Tolerability Study of AVP-923 DextromethorphanQuinidine for Treatment of Symptoms of Agitation in Participants With Alzheimers Disease
Sponsor:
Avanir Pharmaceuticals
Organization:
Avanir Pharmaceuticals
Study Overview
Official Title:
A Phase 2 Randomized Double-dummy Double-blind Placebo-controlled Study to Assess the Efficacy Safety and Tolerability of AVP-923 DextromethorphanQuinidine for the Treatment of Symptoms of Agitation in Patients With Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2021-10
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:
The objectives of the study are to evaluate the safety tolerability and efficacy of AVP-923 compared to placebo for the treatment of symptoms of agitation in participants with Alzheimers Disease AD
Detailed Description:
Eligible participants for this study must have a diagnosis of probable AD and must have clinically meaningful agitation secondary to AD
This is a multicenter randomized double-dummy double-blind placebo-controlled study consisting of 10 weeks of treatment
Up to 200 participants will be enrolled at approximately 30-40 centers in the US
Study medication will be administered orally twice-daily from Day 1 through Day 70 Screening must occur within 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-dummy double-blind placebo-controlled study consisting of 10 weeks of treatment
Up to 200 participants will be enrolled at approximately 30-40 centers in the US
Study medication will be administered orally twice-daily from Day 1 through Day 70 Screening must occur within 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?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None