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

NCT01584440 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2021-11-26

Study results available
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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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Avanir Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-13
Primary Completion
2014-07-30
Completion
2014-07-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01584440 on ClinicalTrials.gov