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Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Alzheimer's Patients
| Tracking Information | |||
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| First Received Date ICMJE | April 23, 2012 | ||
| Last Updated Date | September 18, 2014 | ||
| Start Date ICMJE | June 2012 | ||
| Primary Completion Date | July 2014 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Neuropsychiatric Inventory (NPI) [ Time Frame: 10 weeks ] Primary Endpoint: Agitation/Aggression Domain of NPI |
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| Original Primary Outcome Measures ICMJE |
Neuropsychiatric Inventory (NPI) [ Time Frame: 10 weeks ] | ||
| Change History | Complete list of historical versions of study NCT01584440 on ClinicalTrials.gov Archive Site | ||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||
| Original Other Outcome Measures ICMJE | 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. |
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| Study Type ICMJE | Interventional | ||
| Study Phase | Phase 2 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Intervention ICMJE |
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| 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. | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Enrollment ICMJE | 220 | ||
| Completion Date | September 2014 | ||
| 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. |
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| Ages | 50 Years to 90 Years (Adult, Senior) | ||
| Accepts Healthy Volunteers | 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 | 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 | September 2014 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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