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AVP-786 for the Treatment of Agitation in Alzheimer's

Recruiting

This Phase III clinical trial will evaluate the efficacy, safety, and tolerability of the drug AVP-786 as a treatment for agitation in people with Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 90 Years All No
October 13, 2017
June 2021
412

  • Diagnosis of probable Alzheimer's disease
  • Moderate to severe agitation that interferes with daily routine (and for which medication could be prescribed) for at least 2 weeks
  • A Clinical Global Impression Scale for Agitation score of 4 (moderately ill) at screening and baseline
  • Caregiver who spends at least 2 hours per day, 4 days per week with the person with Alzheimer's and can reliably assess changes in participant's condition during the study

  • Dementia predominantly of non-Alzheimer's type, such as vascular dementia, frontotemporal dementia, Parkinson's disease, or substance-induced dementia
  • Agitation not related to Alzheimer's disease, such as a psychiatric disorder or delirium
  • Clinically significant or unstable systemic diseases that could interfere with study results (for example, malignancy; poorly controlled diabetes or high blood pressure; unstable lung, kidney, or liver disease; unstable ischemic heart disease; dilated heart muscle disease; or unstable valvular heart disease)
  • Myasthenia gravis

Participants will be randomly assigned to take one of two doses of the study drug or a placebo as a capsule twice a day for 12 weeks. AVP-786 is an investigational drug product consisting of a combination of dextromethorphan, a central nervous system agent that has been approved to temporarily relieve cough, and quinidine, an antiarrhythmic that is approved to treat abnormal heart rhythms. When combined with dextromethorphan, quinidine works by increasing the amount of dextromethorphan in the body.

For more information about this study or study sites, contact Fred Ledon at 949-389-6724 or fledon@avanir.com.

Name City State Zip Status Primary Contact
Liv Generations of Ahwatukee / CCT
Phoenix Arizona 85048 Recruiting

Perseverance Research Center
Scottsdale Arizona 85254 Recruiting

Clinical Trials Inc.
Little Rock Arkansas 72205 Terminated

Paradigm Clinical Research Centers, Inc.
La Mesa California 91942 Active, not recruiting

Havana Research Institute
Pasadena California 91105 Recruiting

SFM Clinical Research, LLC
Boca Raton Florida 33487 Recruiting

Helix Biomedics LLC
Boynton Beach Florida 33436 Terminated

Alzheimer's Research and Treatment Center
Lake Worth Florida 33449 Recruiting

Meridien Research - Lakeland Site
Lakeland Florida 33805 Terminated

Zynak Clinical Services
Lauderdale Lakes Florida 33313 Terminated

City Medical Group RC
Miami Florida 33126 Terminated

Finlay Medical Research Corp
Miami Florida 33126 Active, not recruiting

Miami Jewish Health Systems, Inc.
Miami Florida 33137 Recruiting

Clinical Research Associates of South Florida
Miami Florida 33172 Active, not recruiting

Pharmax Research of South Florida
Miami Florida 33175 Recruiting

Research Institute of West Kendall
Miami Florida 33186 Terminated

Crystal Biomedical Research, LLC
Miami Lakes Florida 33014 Active, not recruiting

Bayside Clinical Research
New Port Richey Florida 34655 Recruiting

Academic Alliance in Dermatology
Tampa Florida 33617 Recruiting

NeuroStudies. Net, LLC
Decatur Georgia 30033 Active, not recruiting

Onyx Clinical Research, LLC
Caro Michigan 48723 Terminated

Galen Research
Chesterfield Missouri 63005 Recruiting

Bio Behavioral Health
Toms River New Jersey 08755 Recruiting

Nathan S. Kline Institute for Psychiatric Research
Orangeburg New York 10962 Recruiting

Insight Clinical Trials LLC
Beachwood Ohio 44122 Recruiting

Valley Medical Research
Centerville Ohio 45459 Recruiting

Onyx Clinical Research, LLC
Youngstown Ohio 44505 Recruiting

Newton Clinical Research
Oklahoma City Oklahoma 73102 Active, not recruiting

Keystone Clinical Studies, LLC
Norristown Pennsylvania 19403 Recruiting

InSite Clinical Research
DeSoto Texas 75115 Recruiting

Northwest Clinical Research Center
Bellevue Washington 98007 Recruiting

IPC Research
Waukesha Wisconsin 53188 Recruiting

Avanir Pharmaceuticals

Name Phone Email
Fred Ledon 949-389-6724 fledon@avanir.com

NCT03393520

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 Pati