Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
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|ClinicalTrials.gov Identifier: NCT03393520|
Recruitment Status : Recruiting
First Posted : January 8, 2018
Last Update Posted : October 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Agitation in Patients With Dementia of the Alzheimer's Type||Drug: Placebo Drug: AVP-786||Phase 3|
Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||550 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type|
|Actual Study Start Date :||October 13, 2017|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
Placebo Comparator: Placebo
Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.
Experimental: AVP-786; Dose 1
Participants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.
Experimental: AVP-786; Dose 2
Participants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.
- Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score [ Time Frame: Baseline; Week 12 ]
- Change from Baseline to Week 12 in the Clinical Global Impression of Severity (CGIS)-Agitation Domain Score [ Time Frame: Baseline; Week 12 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393520
|Contact: Fred Ledon||+1 949 389-6724||FLedon@avanir.com|
|Contact: Caroline Mason||+44 (00) 7551 125 782||CMason@Otsuka-Europe.com|