NCT01584440

Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Participants With Alzheimer's Disease

A Phase 2, Randomized, Double-dummy, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of AVP-923 (Dextromethorphan/Quinidine) for the Treatment of Symptoms of Agitation in Patients With Alzheimer's Disease.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Avanir Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

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 Alzheimer's 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.

Conditions

• Agitation
• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	AVP-923-20	AVP-923-20: 20 mg of dextromethorphan and 10 mg of quinidine
DRUG	Placebo	Placebo capsule
DRUG	AVP-923-30	AVP-923-30: 30 mg of dextromethorphan and 10 mg of quinidine

Timeline

• Start date: 2012-08-13
• Primary completion: 2014-07-30
• Completion: 2014-07-30
• First posted: 2012-04-25
• Last updated: 2021-11-26
• Results posted: 2021-11-26

Locations

44 sites across 1 country: United States