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 : February 24, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Agitation in Patients With Dementia of the Alzheimer's Type | Drug: AVP-786 | Phase 3 |
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 1000 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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1000 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 : | October 2023 |
Estimated Study Completion Date : | October 2023 |

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 |
- Number of Participants with any Treatment-Emergent Adverse Event [ Time Frame: up to 64 weeks ]
- Number of Participants with any Treatment-Emergent Serious Adverse Event [ Time Frame: up to 64 weeks ]
- Number of Participants with any abnormal, clinically significant Clinical Laboratory Value [ Time Frame: up to 52 weeks ]
- Number of Participants with any abnormal, clinically significant 12-lead Electrocardiogram (ECG) value [ Time Frame: up to 52 weeks ]
- Number of Participants with any abnormal, clinically significant Physical and Neurological Examination finding [ Time Frame: up to 52 weeks ]
- Number of participants with any abnormal, clinically significant vital sign value [ Time Frame: up to 52 weeks ]
- Change from Baseline to Week 64 in the Sheehan Suicidality Tracking Scale (S-STS) Score [ Time Frame: Baseline; Week 64 ]
- Change from Baseline to Week 52 in the Mini-Mental State Examination (MMSE) Score [ Time Frame: Baseline; Week 52 ]
- Change from Baseline to Week 52 in the Epworth Sleepiness Scale (ESS) Score [ Time Frame: Baseline; Week 52 ]
- Change from Baseline to Week 64 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score [ Time Frame: Baseline; Week 64 ]
- 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 ]
- 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 ]
- Change from Baseline to Week 52 in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score [ Time Frame: Baseline; Week 52 ]
- Change from Baseline to Week 52 in the Patient Global Impression of Change (PGIC) Score [ Time Frame: Baseline; Week 52 ]PGIC (rated by caregiver)
- Change from Baseline to Week 52 in the Dementia Quality of Life (DEMQOL) Score [ Time Frame: Baseline; Week 52 ]
- Change from Baseline to Week 52 in the Resource Utilization in Dementia (RUD) Score [ Time Frame: Baseline; Week 52 ]
- 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 ]
- Number of participants using concomitant medications [ Time Frame: up to 64 weeks ]

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

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
Contact: Fred Ledon | 949-389-6724 | fledon@avanir.com | |
Contact: Nadine Knowles | 949-268-8972 | nknowles@avanir.com |

Responsible Party: | Avanir Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT02446132 |
Other Study ID Numbers: |
15-AVP-786-303 |
First Posted: | May 18, 2015 Key Record Dates |
Last Update Posted: | February 24, 2021 |
Last Verified: | February 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |