Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01584440
Recruitment Status : Completed
First Posted : April 25, 2012
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE April 23, 2012
First Posted Date  ICMJE April 25, 2012
Last Update Posted Date January 11, 2018
Study Start Date  ICMJE June 2012
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2014)
Neuropsychiatric Inventory (NPI) [ Time Frame: 10 weeks ]
Primary Endpoint: Agitation/Aggression Domain of NPI
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2012)
Neuropsychiatric Inventory (NPI) [ Time Frame: 10 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2014)
  • Safety and Tolerability [ Time Frame: 10 weeks ]
    Standard Measurements (e.g. AEs, ECG, Labs, PE and Neuro Exam)
  • Neuropsychiatric Inventory (NPI) [ Time Frame: 10 weeks ]
    Total NPI
  • Neuropsychiatric Inventory (NPI) [ Time Frame: 10 weeks ]
    Caregiver Distress for NPI Domains
  • Neuropsychiatric Inventory (NPI) [ Time Frame: 10 weeks ]
    NPI-4A (Composite of 4 NPI Domains)
  • Neuropsychiatric Inventory (NPI) [ Time Frame: 10 weeks ]
    NPI-4D (Composite of 4 NPI Domains)
  • Neuropsychiatric Inventory (NPI) [ Time Frame: 10 weeks ]
    Individual Domains of NPI
  • ADCS-CGIC (Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change Rating) [ Time Frame: 10 weeks ]
    Agitation and Overall
  • PGIC Patient Global Impression of Change (PGI-C) [ Time Frame: 10 weeks ]
    Agitation (Rated by Caregiver)
  • QoL-AD (Quality of Life - Alzheimer's Disease measure) [ Time Frame: 10 weeks ]
  • ADCS-ADL (Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory) [ Time Frame: 10 weeks ]
  • CSI (Caregiver Strain Index) [ Time Frame: 10 weeks ]
  • CSDD (Cornell Scale for Depression in Dementia) [ Time Frame: 10 weeks ]
  • (MMSE) Mini-Mental State Examination [ Time Frame: 10 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2012)
  • ADCS-ADL [ Time Frame: 10 weeks ]
  • PGIC [ Time Frame: 10 weeks ]
  • ADCS-CGIC [ Time Frame: 10 weeks ]
  • QoL-AD [ Time Frame: 10 weeks ]
  • CSDD [ Time Frame: 10 weeks ]
  • CSI [ Time Frame: 10 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Alzheimer's Patients
Official Title  ICMJE 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.
Brief 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 patients with Alzheimer's Disease (AD).
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 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 patients will be randomized into the study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Agitation
  • Alzheimer's Disease
Intervention  ICMJE
  • Drug: AVP-923 (dextromethorphan/quinidine)
    AVP-923 capsules administered twice a day over a 10-week period
  • Drug: Placebo
    Placebo capsules administered twice a day over a 10-week period
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: AVP-923
    Intervention: Drug: AVP-923 (dextromethorphan/quinidine)
Publications * Cummings JL, Lyketsos CG, Peskind ER, Porsteinsson AP, Mintzer JE, Scharre DW, De La Gandara JE, Agronin M, Davis CS, Nguyen U, Shin P, Tariot PN, Siffert J. Effect of Dextromethorphan-Quinidine on Agitation in Patients With Alzheimer Disease Dementia: A Randomized Clinical Trial. JAMA. 2015 Sep 22-29;314(12):1242-54. doi: 10.1001/jama.2015.10214.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2014)
220
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2012)
200
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 28 (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. In order to qualify as a caregiver for this study, the individual should spend time with the patient for a minimum of 4 hours on 4 separate days per week.

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01584440
Other Study ID Numbers  ICMJE 12-AVR-131
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Avanir Pharmaceuticals
Study Sponsor  ICMJE Avanir Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Avanir Pharmaceuticals
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP