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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

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ClinicalTrials.gov Identifier: NCT02446132
Recruitment Status : Recruiting
First Posted : May 18, 2015
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals

Study Description
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Brief Summary:
This is an extension study of the Phase 3 Studies 15-AVP-786-301 and 15-AVP-786-302, 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, or 12-AVR-131.

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 700 participants will be enrolled at approximately 135 centers in North America.

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 : 700 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 : June 2022
Estimated Study Completion Date : June 2022

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 Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score [ Time Frame: Baseline; Week 52 ]
  10. Change from Baseline to Week 52 in the Timed Up and Go (TUG) Test Score [ Time Frame: Baseline; Week 52 ]
  11. 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 52 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score [ Time Frame: Baseline; Week 64 ]
  2. Change from Baseline to Week 52 in the Neuropsychiatric Inventory (NPI) Total Score [ Time Frame: Baseline; Week 52 ]
  3. Change from Baseline to Week 52 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 22 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 ADCS-CGIC Overall Score [ Time Frame: Baseline; Week 52 ]
  6. Change from Baseline to Week 52 in the Zarit Burden Interview (ZBI) Score [ Time Frame: Baseline; Week 52 ]
  7. Change from Baseline to Week 52 in the Patient Global Impression of Change (PGIC) Score [ Time Frame: Baseline; Week 52 ]
    PGIC (rated by caregiver)

  8. Change from Baseline to Week 52 in the Dementia Quality of Life (DEMQOL) Score [ Time Frame: Baseline; Week 52 ]
  9. Change from Baseline to Week 52 in the Cornell Scale for Depression in Dementia (CSDD) Score [ Time Frame: Baseline; Week 52 ]
  10. Change from Baseline to Week 52 in the Resource Utilization in Dementia (RUD) Score [ Time Frame: Baseline; Week 52 ]
  11. Change from Baseline to Week 52 in the General Medical Health Rating (GMHR) Score [ Time Frame: Baseline; Week 52 ]
  12. Change from Baseline to Week 52 in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score [ Time Frame: Baseline; 52 weeks ]

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

Eligibility Criteria
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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, or 12-AVR-131
  • Participants from Study 12-AVR-131 with a diagnosis of probable 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 from Study 12-AVR-131 who have clinically significant, moderate/severe agitation at least 2 weeks prior to baseline
  • Participants from Study 12-AVR-131 with a diagnosis of agitation that must meet the International Psychogeriatric Association (IPA) provisional definition of agitation
  • Participants from Study 12-AVR-131 with a Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation of ≥ 4 (moderately ill) at screening and baseline
  • Participants from Study 12-AVR-131 with 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: Fred Ledon 949-389-6724 fledon@avanir.com
Contact: Nadine Knowles 949-268-8972 nknowles@avanir.com

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Sponsors and Collaborators
Avanir Pharmaceuticals
More Information
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Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02446132     History of Changes
Other Study ID Numbers: 15-AVP-786-303
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019

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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
Signs and Symptoms