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

Last updated: October 29, 2021
Sponsor: Avanir Pharmaceuticals
Overall Status: Completed

Phase

2

Condition

Williams Syndrome

Memory Loss

Manic Disorders

Treatment

N/A

Clinical Study ID

NCT01584440
12-AVR-131
  • Ages 50-90
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Key Inclusion Criteria: Diagnosis of probable Alzheimer's disease (AD). The participant has clinically significant symptoms of agitation secondary to AD, thatinterfere with daily routine and for which a prescription medication is deemed indicated,in the opinion of the investigator. Either out-patients or residents of an assisted-living facility or a skilled nursing home. CGI-S score is ≥ 4 (moderately ill) at screening and baseline. Mini Mental State Examination (MMSE) score at screening between 8 and 28 (inclusive). Caregiver who is able and willing to comply with all required study procedures, ensuringthat the participant attends all study visits and takes the study medication as instructed.In order to qualify as a caregiver for this study, the individual should spend time withthe participant for a minimum of 4 hours on 4 separate days per week.

Exclusion

Key Exclusion Criteria: Participant has other type of dementia (e.g., vascular dementia, frontotemporal dementia,Parkinson's disease, substance-induced dementia). Participant with co-existent clinically significant or unstable systemic diseases thatcould confound the interpretation of the safety results of the study (e.g. malignancy,poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal orhepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, certain cardiacconduction abnormalities including QTc prolongation, or unstable valvular heart disease). Participant with myasthenia gravis.

Study Design

Total Participants: 220
Study Start date:
August 13, 2012
Estimated Completion Date:
July 30, 2014

Study 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.

Connect with a study center

  • Phoenix, Arizona 85006
    United States

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  • Sun City, Arizona 85351
    United States

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  • Fresno, California 93720
    United States

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  • Fullerton, California 92835
    United States

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  • Los Angeles, California 90073
    United States

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  • San Diego, California 92103
    United States

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  • San Francisco, California 94109
    United States

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  • Sherman Oaks, California 91403
    United States

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  • Temecula, California 92591
    United States

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  • Boynton Beach, Florida 33426
    United States

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  • Deerfield Beach, Florida 33064
    United States

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    Fort Myers, Florida 33912
    United States

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  • Hialeah, Florida 33012
    United States

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  • Miami, Florida 33122
    United States

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  • Ocala, Florida 34471
    United States

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  • Orlando, Florida 32806
    United States

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  • Sunrise, Florida 33351
    United States

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  • Tampa, Florida 33609
    United States

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  • West Palm Beach, Florida 33409
    United States

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  • Weston, Florida 33331
    United States

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  • Elk Grove Village, Illinois 60007
    United States

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    New Orleans, Louisiana 70114
    United States

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    Plymouth, Massachusetts 02360
    United States

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    Saint Louis, Missouri 63104
    United States

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  • Las Vegas, Nevada 89106
    United States

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    Marlton, New Jersey 08053
    United States

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  • Summit, New Jersey 07902
    United States

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  • Toms River, New Jersey 08757
    United States

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  • Orangeburg, New York 10962
    United States

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  • Rochester, New York 14620
    United States

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  • White Plains, New York 10605
    United States

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  • Centerville, Ohio 45459
    United States

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  • Cincinnati, Ohio 45227
    United States

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  • Cleveland, Ohio 44195
    United States

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  • Columbus, Ohio 43221
    United States

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  • Lakewood, Ohio 44107
    United States

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  • Allentown, Pennsylvania 18104
    United States

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  • Reading, Pennsylvania 19604
    United States

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  • Charleston, South Carolina 29401
    United States

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    North Charleston, South Carolina 29406
    United States

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  • Houston, Texas 77030
    United States

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  • San Antonio, Texas 78238
    United States

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  • Salt Lake City, Utah 84106
    United States

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  • Bennington, Vermont 05201
    United States

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  • Spokane, Washington 99204
    United States

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