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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01584440
First received: April 23, 2012
Last updated: September 18, 2014
Last verified: September 2014

April 23, 2012
September 18, 2014
June 2012
July 2014   (final data collection date for primary outcome measure)
Neuropsychiatric Inventory (NPI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Primary Endpoint: Agitation/Aggression Domain of NPI
Neuropsychiatric Inventory(NPI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01584440 on ClinicalTrials.gov Archive Site
  • Safety and Tolerability [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
    Standard Measurements (e.g. AEs, ECG, Labs, PE and Neuro Exam)
  • Neuropsychiatric Inventory (NPI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Total NPI
  • Neuropsychiatric Inventory (NPI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Caregiver Distress for NPI Domains
  • Neuropsychiatric Inventory (NPI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    NPI-4A (Composite of 4 NPI Domains)
  • Neuropsychiatric Inventory (NPI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    NPI-4D (Composite of 4 NPI Domains)
  • Neuropsychiatric Inventory (NPI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Individual Domains of NPI
  • ADCS-CGIC (Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change Rating) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Agitation and Overall
  • PGIC Patient Global Impression of Change (PGI-C) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Agitation (Rated by Caregiver)
  • 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 ]
  • CSDD (Cornell Scale for Depression in Dementia) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • (MMSE) Mini-Mental State Examination [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • ADCS-ADL [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • PGIC [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • ADCS-CGIC [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • QoL-AD [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • CSDD [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • CSI [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Alzheimer's Patients
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.

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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Agitation
  • Alzheimer's Disease
  • 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
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: AVP-923
    Intervention: Drug: AVP-923 (dextromethorphan/quinidine)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
September 2014
July 2014   (final data collection date for primary outcome measure)

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.

Both
50 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01584440
12-AVR-131
Yes
Avanir Pharmaceuticals
Avanir Pharmaceuticals
Not Provided
Not Provided
Avanir Pharmaceuticals
September 2014

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