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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

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ClinicalTrials.gov Identifier: NCT04464564
Recruitment Status : Recruiting
First Posted : July 9, 2020
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals

Brief Summary:
This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.

Condition or disease Intervention/treatment Phase
Agitation in Patients With Dementia of the Alzheimer's Type Drug: AVP-786 Drug: Placebo Phase 3

Detailed Description:

Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD.

This is a multicenter, randomized, double-blind, placebo-controlled study, consisting of 12 weeks of treatment.

Approximately 750 participants will be enrolled at approximately 110 centers worldwide.

Study medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess 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
Actual Study Start Date : September 3, 2020
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AVP-786
Participants will be assigned to treatment with AVP-786 capsules administered twice a day over a 12-week period.
Drug: AVP-786
oral capsules

Placebo Comparator: Placebo
Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.
Drug: Placebo
oral capsules




Primary Outcome Measures :
  1. Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score [ Time Frame: Baseline; Week 12 ]

Secondary Outcome Measures :
  1. Change from Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGI-S) Score, as Related to Agitation [ Time Frame: Baseline; Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with a diagnosis of probable Alzheimer's disease according to the 2011 Neuropsychiatric Inventory Agitation/Aggression (NPI-AA) working groups 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 dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04464564


Contacts
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Contact: Chaz De Naranjo 949-389-6771 cdenaranjo@avanir.com
Contact: Jose Contreras 949-389-6744 jcontreras@avanir.com

Locations
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United States, Arizona
Clinical Research Site Recruiting
Phoenix, Arizona, United States, 85004
Clinical Research Site Recruiting
Tucson, Arizona, United States, 85719
United States, Arkansas
Clinical Research Site Recruiting
Little Rock, Arkansas, United States, 72211
United States, California
Clinical Research Site Recruiting
Encino, California, United States, 91316
Clinical Research Site Recruiting
Los Angeles, California, United States, 90024
Clinical Research Site Recruiting
Panorama City, California, United States, 91402
Clinical Research Site Recruiting
San Diego, California, United States, 92128
Clinical Research Site Recruiting
Santa Ana, California, United States, 92705
United States, Florida
Clinical Research Site Active, not recruiting
Doral, Florida, United States, 33166
Clinical Research Site Recruiting
Hallandale Beach, Florida, United States, 33009
Clinical Research Site Recruiting
Lady Lake, Florida, United States, 32159
Clinical Research Site #4 Recruiting
Miami, Florida, United States, 33126
Clinical Research Site #3 Recruiting
Miami, Florida, United States, 33145
Clinical Research Site Recruiting
Pensacola, Florida, United States, 32502
Clinical Research Site Recruiting
Winter Park, Florida, United States, 32789
United States, Massachusetts
Clinical Research Site Active, not recruiting
Newton, Massachusetts, United States, 02459
United States, Michigan
Clinical Research Site Recruiting
Bloomfield Township, Michigan, United States, 48302
United States, Missouri
Clinical Research Site Recruiting
O'Fallon, Missouri, United States, 63368
United States, New York
Clinical Research Site Recruiting
Buffalo, New York, United States, 14030
Clinical Research Site Recruiting
Manhasset, New York, United States, 11030
United States, Virginia
Clinical Research Site Recruiting
Alexandria, Virginia, United States, 22311
Canada, British Columbia
Clinical Research Site Recruiting
Kelowna, British Columbia, Canada, V1Y 1Z9
Canada, Ontario
Clinical Research Site Recruiting
Sarnia, Ontario, Canada, N7T 4X3
Canada, Quebec
Clinical Research Site Recruiting
Montreal, Quebec, Canada, H1M 1B1
Clinical Research Site Recruiting
Quebec City, Quebec, Canada, G3K 2P8
Clinical Research Site Recruiting
Sherbrooke, Quebec, Canada, J1L 0H8
Hungary
Clinical Research Site #1 Recruiting
Budapest, Hungary, 1036
Clinical Research Site #2 Recruiting
Budapest, Hungary, 1036
Slovakia
Clinical Research Site Recruiting
Bardejov, Slovakia, 08501
Clinical Research Site Recruiting
Trencin, Slovakia, 91108
Clinical Research Site Recruiting
Vranov Nad Topľou, Slovakia, 09301
Spain
Clinical Research Site Recruiting
Sant Cugat del Vallès, Spain, 08195
Sponsors and Collaborators
Avanir Pharmaceuticals
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Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04464564    
Other Study ID Numbers: 20-AVP-786-307
2020-000799-39 ( EudraCT Number )
First Posted: July 9, 2020    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Avanir Pharmaceuticals:
Agitation
Dementia of the Alzheimer's type
Alzheimer's disease
AVP-786
Deudextromethorphan hydrobromide
Quinidine sulfate
Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations