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Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02446132
Recruitment Status : Recruiting
First Posted : May 18, 2015
Last Update Posted : March 27, 2023
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Description
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Brief Summary:
This is an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305, which also allows participants from the Phase 2 Study 12-AVR-131 to be included.

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

Detailed Description:

Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305.

Participants will be enrolled in the study for approximately 56 weeks (participants who have a follow-up visit 3 months after the last dose of treatment will be enrolled for approximately 64 weeks).

Approximately 1200 participants will be enrolled at approximately 250 centers globally.

All participants enrolled will receive AVP-786; the treatment dose assigned will be masked to the participant, investigator, study staff, and the sponsor.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Long Term, Extension Study of the Safety and Efficacy of AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Study Start Date : December 2015
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: AVP-786 (dose 1)
AVP-786 dose 1; capsules administered twice a day over a 52-week period
 Drug: AVP-786
Experimental: AVP-786 (dose 2)
AVP-786 dose 2; capsules administered twice a day over a 52-week period
 Drug: AVP-786
Experimental: AVP-786 (dose 3)
AVP-786 dose 3; capsules administered twice a day over a 52-week period
 Drug: AVP-786


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with any Treatment-Emergent Adverse Event [ Time Frame: up to 64 weeks ]
  2. Number of Participants with any Treatment-Emergent Serious Adverse Event [ Time Frame: up to 64 weeks ]
  3. Number of Participants with any abnormal, clinically significant Clinical Laboratory Value [ Time Frame: up to 52 weeks ]
  4. Number of Participants with any abnormal, clinically significant 12-lead Electrocardiogram (ECG) value [ Time Frame: up to 52 weeks ]
  5. Number of Participants with any abnormal, clinically significant Physical and Neurological Examination finding [ Time Frame: up to 52 weeks ]
  6. Number of participants with any abnormal, clinically significant vital sign value [ Time Frame: up to 52 weeks ]
  7. Change from Baseline to Week 64 in the Sheehan Suicidality Tracking Scale (S-STS) Score [ Time Frame: Baseline; Week 64 ]
  8. Change from Baseline to Week 52 in the Mini-Mental State Examination (MMSE) Score [ Time Frame: Baseline; Week 52 ]
  9. Change from Baseline to Week 52 in the Epworth Sleepiness Scale (ESS) Score [ Time Frame: Baseline; Week 52 ]

Secondary Outcome Measures :
  1. Change from Baseline to Week 64 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score [ Time Frame: Baseline; Week 64 ]
  2. Change from Baseline to Week 52 in the Agitation/Aggression, Irritability/Lability, and Aberrant Motor Behavior Domain Scores of the Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline; Week 52 ]
  3. Change from Baseline to Week 64 in the modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change-Agitation (mADCS-CGIC-Agitation) Score [ Time Frame: Baseline; Week 64 ]
  4. Change from Baseline to Week 52 in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score [ Time Frame: Baseline; Week 52 ]
  5. Change from Baseline to Week 52 in the Patient Global Impression of Change (PGIC) Score [ Time Frame: Baseline; Week 52 ]
    PGIC (rated by caregiver)

  6. Change from Baseline to Week 52 in the Dementia Quality of Life (DEMQOL) Score [ Time Frame: Baseline; Week 52 ]
  7. Change from Baseline to Week 52 in the Resource Utilization in Dementia (RUD) Score [ Time Frame: Baseline; Week 52 ]
  8. Change from Baseline to Week 52 in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) for Participants from Study 17-AVP-786-305 [ Time Frame: Baseline; Week 52 ]

Other Outcome Measures:
  1. Number of participants using concomitant medications [ Time Frame: up to 64 weeks ]

Eligibility Criteria
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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:

  • Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305. (Note: A delay in enrollment may include delays associated with COVID-19 restrictions.)
  • Participants with a diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working group criteria
  • Either out-patients or residents of an assisted-living facility or a skilled nursing home
  • Participants who delay enrollment must have clinically significant, moderate/severe agitation at least 2 weeks prior to baseline
  • Participants who delay enrollment must have a diagnosis of agitation that must meet the International Psychogeriatric Association (IPA) provisional definition of agitation
  • Participants who delay enrollment must have a Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation of ≥ 4 (moderately ill) at screening and baseline
  • Participants who delay enrollment must have a Mini-Mental State Examination (MMSE) score between 6 and 26 (inclusive) at screening and baseline

Exclusion Criteria:

  • 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, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
  • Participants determined to have a high imminent risk of falls during the study based on a clinical evaluation by the investigator
  • Participants who are currently using or were on NUEDEXTA® in the 2 weeks preceding baseline
Contacts and Locations
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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): NCT02446132


Contacts
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Contact: Clinical Transparency 240-683-3421 smb_clinicaltranspa@otsuka-us.com

Locations
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Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
More Information
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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT02446132    
Other Study ID Numbers: 15-AVP-786-303
2017-002455-29 ( EudraCT Number )
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: March 27, 2023
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data will be available after marketing approval in global markets or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
URL: https://clinical-trials.otsuka.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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