Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Alzheimer's Patients
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Purpose
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 |
|---|---|---|
|
Agitation 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. |
- Neuropsychiatric Inventory (NPI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]Primary Endpoint: Agitation/Aggression Domain of NPI
- 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 ]
| Enrollment: | 220 |
| Study Start Date: | June 2012 |
| Study Completion Date: | September 2014 |
| Primary Completion Date: | July 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 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.
Eligibility| 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 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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01584440
Show 44 Study Locations
More Information
No publications provided
| Responsible Party: | Avanir Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01584440 History of Changes |
| Other Study ID Numbers: | 12-AVR-131 |
| Study First Received: | April 23, 2012 |
| Last Updated: | September 18, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Alzheimer Disease Psychomotor Agitation Brain Diseases Central Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Dementia Dyskinesias Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodegenerative Diseases Neurologic Manifestations Psychomotor Disorders Signs and Symptoms Tauopathies |
Dextromethorphan Quinidine Adrenergic Agents Adrenergic Antagonists Adrenergic alpha-Antagonists Anti-Arrhythmia Agents Anti-Infective Agents Antimalarials Antiparasitic Agents Antiprotozoal Agents Antitussive Agents Cardiovascular Agents Central Nervous System Agents Cholinergic Agents Cholinergic Antagonists |
ClinicalTrials.gov processed this record on February 27, 2015