Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
NCT ID: NCT04464564
Last Updated: 2025-05-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
241 participants
INTERVENTIONAL
2020-09-11
2024-06-28
Brief Summary
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Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
NCT03393520
Detailed Description
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This was multicenter, randomized, double-blind, placebo-controlled study, consisting of 12 weeks of treatment. Screening occurred within 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants were randomized into the study.
241 participants were enrolled into the study.
Study medication was administered orally twice daily from Day 1 through Day 85.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants who were enrolled in 1-week double-blind placebo lead-in Period A, were then randomized to receive AVP-786 matching placebo capsules, twice a day, for 11 weeks in Period B.
Placebo
oral capsules
AVP-786-18
Participants who were enrolled in 1-week double-blind placebo lead-in Period A, were then randomized to receive AVP-786-18 (d6-DM 18 milligrams (mg)/Q 4.9 mg) capsules, twice a day, for 11 weeks in Period B.
AVP-786
oral capsules
AVP-786-42.63
Participants who were enrolled in 1-week double-blind placebo lead-in Period A, were then randomized to receive AVP-786-42.63 (d6-DM 42.63 mg/Q 4.9 mg) capsules, twice a day, for 11 weeks in Period B.
AVP-786
oral capsules
Interventions
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AVP-786
oral capsules
Placebo
oral capsules
Eligibility Criteria
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Inclusion Criteria
* Participants with clinically significant, moderate-to-severe agitation for at least 2 weeks prior to Screening that interferes with daily routine per the Investigator's judgment
* Participants who require pharmacotherapy for the treatment of agitation per the Investigator's judgment after an evaluation of reversible factors and a course of nonpharmacological interventions
* Diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation.
* Participants meeting an additional predetermined blinded eligibility criterion, which will remain blinded to the clinical study site Investigators and staff
* Participants with a reliable caregiver who is able and willing to comply with all study procedures, including adherence to administering study drug and not administering any prohibited medications during the course of the study, and who spends a minimum of 2 hours per day for 4 days per week with the participant
Exclusion Criteria
* Participants with symptoms of agitation that are not secondary to Alzheimer's dementia (e.g., secondary to pain, other psychiatric disorder, or delirium)
* Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy \[except skin basal-cell carcinoma\], poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
* Participants with myasthenia gravis
50 Years
90 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Research Site #840-020
Phoenix, Arizona, United States
Clinical Research Site #840-047
Anaheim, California, United States
Clinical Research Site #840-090
Costa Mesa, California, United States
Clinical Research Site #840-059
Lafayette, California, United States
Clinical Research Site #840-048
Lomita, California, United States
Clinical Research Site #840-095
Long Beach, California, United States
Clinical Research Site #840-004
Los Angeles, California, United States
Clinical Research Site #840-006
Panorama City, California, United States
Clinical Research Site
San Diego, California, United States
Clinical Research Site #840-070
Apopka, Florida, United States
Clinical Research Site #840-055
Bradenton, Florida, United States
Clinical Research Site #840-096
Cape Coral, Florida, United States
Clinical Research Site #840-077
Clermont, Florida, United States
Clinical Research Site #840-066
Coral Springs, Florida, United States
Clinical Research Site #840-039
Hallandale, Florida, United States
Clinical Research Site #840-089
Kissimmee, Florida, United States
Clinical Research Site #840-034
Lady Lake, Florida, United States
Clinical Research Site #840-037
Miami, Florida, United States
Clinical Research Site #840-092
Miami, Florida, United States
Clinical Research Site #840-041
Miami, Florida, United States
Clinical Research Site #840-007
Miami, Florida, United States
Clinical Research Site #840-103
Miami, Florida, United States
Clinical Research Site #840-042
Miami, Florida, United States
Clinical Research Site #840-051
Naples, Florida, United States
Clinical Research Site #840-087
Orlando, Florida, United States
Clinical Research Site 840-028
Pensacola, Florida, United States
Clinical Research Site # 840-105
Tampa, Florida, United States
Clinical Research Site #840-104
Tampa, Florida, United States
Clinical Research Site #840-049
West Palm Beach, Florida, United States
Clinical Research Site #840-036
Winter Park, Florida, United States
Clinical Research Site #840-065
Atlanta, Georgia, United States
Clinical Research Site #840-030
Chicago, Illinois, United States
Clinical Research Site #840-073
Boston, Massachusetts, United States
Clinical Research Site #840-014
Bloomfield Township, Michigan, United States
Clinical Research Site #840-022
Detroit, Michigan, United States
Clinical Research Site #840-024
O'Fallon, Missouri, United States
Clinical Research Site #840-031
Buffalo, New York, United States
Clinical Research Site #840-021
Manhasset, New York, United States
Clinical Research Site #840-058
New Hyde Park, New York, United States
Clinical Research Site #840-035
Cypress, Texas, United States
Clinical Research Site #840-053
Dallas, Texas, United States
Clinical Research Site #840-093
El Paso, Texas, United States
Clinical Research Site #840-072
Houston, Texas, United States
Clinical Research Site #840-057
Houston, Texas, United States
Clinical Research Site #840-086
Mesquite, Texas, United States
Clinical Research Site #840-044
Fairfax, Virginia, United States
Clinical Research Site #056-005
Alken, Limburg, Belgium
Clinical Research Site #056-004
Brussels, , Belgium
Clinical Research Site #056-003
Leuven, , Belgium
Clinical Research Site # 056-002
Liège, , Belgium
Clinical Research Site #124-003
Kelowna, British Columbia, Canada
Clinical Research Site #124-008
Québec, Quebec, Canada
Clinical Research Site #152-007
Viña Del Mar, Santiago Metropolitan, Chile
Clinical Research Site #152-002
Antofagasta, , Chile
Clinical Research Site #152-005
Independencia, , Chile
Clinical Research Site #152-001
Santiago, , Chile
Clinical Research Site #152-003
Santiago, , Chile
Clinical Research Site #152-006
Santiago, , Chile
Clinical Research Site #170-003
Bogotá, Columbia, Colombia
Clinical Research Site #170-002
Pereira, Columbia, Colombia
Clinical Research Site #170-007
Floridablanca, Santander Department, Colombia
Clinical Research Site #170-006
Bello, , Colombia
Clinical Research Site #170-001
Bogotá, , Colombia
Clinical Research Site #170-004
Bogotá, , Colombia
Clinical Research Site #191-008
Pula, Istria County, Croatia
Clinical Research Site# 191-006
Rijeka, , Croatia
Clinical Research Site# 191-001
Zagreb, , Croatia
Clinical Research Site #191-003
Zagreb, , Croatia
Clinical Research Site #191-005
Zagreb, , Croatia
Clinical Research Site #191-002
Zagreb, , Croatia
Clinical Research Site #348-002
Gyöngyös, Heves County, Hungary
Clinical Research Site #384-001
Budapest, , Hungary
Clinical Research Site #384-003
Budapest, , Hungary
Clinical Research Site #348-004
Zalaegerszeg, , Hungary
Clinical Research Site #372-002
Cork, , Ireland
Clinical Research Site #372-003
Cork, , Ireland
Clinical Research Site #372-004
Dublin, , Ireland
Clinical Research Site #372-001
Dublin, , Ireland
Clinical Research Site # 484-004
Mexico City, , Mexico
Clinical Research Site #484-008
Mérida, , Mexico
Clinical Research Site #484-006
Monterrey, , Mexico
Clinical Research Site #484-005
Monterrey, , Mexico
Clinical Research Site # 484-003
Monterrey, , Mexico
Clinical Research Site #484-010
Saltillo, , Mexico
Clinical Research Site # 484-002
Sinaloa, , Mexico
Clinical Research Site #484-009
Tlalnepantla, , Mexico
Clinical Trial Site #528-001
Amsterdam, , Netherlands
Clinical Research Site #703-009
Dubnica Nad Váhom, Bratislava Region, Slovakia
Clinical Research Site #703-104
Rimavská Sobota, Sobota, Slovakia
Clinical Research Site #703-006
Banská Bystrica, , Slovakia
Clinical Research Site #703-002
Bardejov, , Slovakia
Clinical Research Site #703-005
Košice, , Slovakia
Clinical Research Site #703-003
Trenčín, , Slovakia
Clinical Research Site #703-001
Vranov nad Topľou, , Slovakia
Clinical Research Site #705-006
Murska Sobota, Brezovica, Slovenia
Clinical Research Site #705-004
Begunje na Gorenjskem, , Slovenia
Clinical Research Site #705-003
Ljubljana, , Slovenia
Clinical Research Site #705-002
Ljubljana, , Slovenia
Clinical Research Site #705-005
Maribor, , Slovenia
Clinical Research Site #705-001
Nova Gorica, , Slovenia
Clinical Research Site #724-013
Seville, Andalusia, Spain
Clinical Research Site #724-011
Palma de Mallorca, Balearic Islands, Spain
Clinical Research Site #724-012
Alicante, Valenciana, Comunitat, Spain
Clinical Research Site # 724-007
Coslada, , Spain
Clinical Research Site #724-009
Madrid, , Spain
Clinical Research Site #724-006
Madrid, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-000799-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-504991-31-00
Identifier Type: CTIS
Identifier Source: secondary_id
20-AVP-786-307
Identifier Type: -
Identifier Source: org_study_id
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