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

This study is currently recruiting participants.
Verified January 2014 by Avanir Pharmaceuticals
Information provided by (Responsible Party):
Avanir Pharmaceuticals Identifier:
First received: April 23, 2012
Last updated: January 7, 2014
Last verified: January 2014

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 patients with Alzheimer's Disease (AD).

Condition Intervention Phase
Alzheimer's Disease
Drug: AVP-923 (dextromethorphan/quinidine)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by Avanir Pharmaceuticals:

Primary Outcome Measures:
  • Neuropsychiatric Inventory (NPI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and Tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Standard Measurements (e.g. AEs, ECG, Labs, PE and Neuro Exam)

  • ADCS-CGIC (Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change Rating) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • QoL-AD (Quality of Life - Alzheimer's Disease measure) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • ADCS-ADL (Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • CSI (Caregiver Strain Index) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo capsules administered twice a day over a 10-week period
Experimental: AVP-923 Drug: AVP-923 (dextromethorphan/quinidine)
AVP-923 capsules administered twice a day over a 10-week period

Detailed Description:

Eligible patients 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 patients will be enrolled at approximately 40 centers in the US.

Study medication will be administered orally twice-daily from Day 1 through Day 70. Screening must occur within 2 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible patients will be randomized into the study.


Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

Diagnosis of probable Alzheimer's disease (AD).

The patient has clinically significant symptoms of agitation secondary to AD, that interfere 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 26(inclusive).

Caregiver who is able and willing to comply with all required study procedures, ensuring that the patient attends all study visits and takes the study medication as instructed. Caregiver must spend time with the patient a minimum of 4 times per week on 4 separate days.

Key Exclusion Criteria:

Patient has other type of dementia (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia).

Patients with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g. malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, certain cardiac conduction abnormalities including QTc prolongation, or unstable valvular heart disease).

Patients with myasthenia gravis.

  Contacts and Locations
Please refer to this study by its identifier: NCT01584440

Contact: Paul Shin 949.268.5930
Contact: Joao Siffert, MD 949.268.1174

  Hide Study Locations
United States, Arizona
Phoenix, Arizona, United States, 85006
Sun City, Arizona, United States, 85351
United States, California
Fresno, California, United States, 93720
Los Angeles, California, United States, 90095
San Diego, California, United States, 92103
San Francisco, California, United States, 94109
Sherman Oaks, California, United States, 91403
United States, Florida
Deerfield Beach, Florida, United States, 33064
Miami, Florida, United States, 33137
Sunrise, Florida, United States, 33351
Tampa, Florida, United States, 33613
West Palm Beach, Florida, United States, 33407
West Palm Beach, Florida, United States, 33409
Weston, Florida, United States, 33331
United States, Illinois
Elk Grove Village, Illinois, United States, 60007
United States, Nevada
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Summit, New Jersey, United States, 07902
Toms River, New Jersey, United States, 08757
United States, New York
Orangeburg, New York, United States, 10962
Rochester, New York, United States, 14620
United States, Ohio
Centerville, Ohio, United States, 45459
Cleveland, Ohio, United States, 44195
Columbus, Ohio, United States, 43221
Lakewood, Ohio, United States, 44107
United States, South Carolina
North Charleston, South Carolina, United States, 29406
United States, Texas
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78238
United States, Utah
Salt Lake City, Utah, United States, 84106
United States, Vermont
Bennington, Vermont, United States, 05201
Sponsors and Collaborators
Avanir Pharmaceuticals
  More Information

No publications provided

Responsible Party: Avanir Pharmaceuticals Identifier: NCT01584440     History of Changes
Other Study ID Numbers: 12-AVR-131
Study First Received: April 23, 2012
Last Updated: January 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psychomotor Agitation
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Quinidine gluconate
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antitussive Agents
Central Nervous System Agents
Therapeutic Uses
Respiratory System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents processed this record on April 15, 2014