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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Avanir Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02446132
First received: May 11, 2015
Last updated: July 21, 2016
Last verified: July 2016
  Purpose
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 Intervention Phase
Agitation in Alzheimer's Disease
Drug: AVP-786
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Avanir Pharmaceuticals:

Primary Outcome Measures:
  • Treatment Emergent Adverse Event, Serious Adverse Event [ Time Frame: 52 weeks ]
  • Clinical Laboratory Assessments [ Time Frame: 52 weeks ]
  • 12-lead Electrocardiograms (ECGs) [ Time Frame: 52 weeks ]
  • Physical and Neurological Examinations [ Time Frame: 52 weeks ]
  • Vital signs [ Time Frame: 52 weeks ]
  • Sheehan Suicidality Tracking Scale (S-STS) [ Time Frame: 52 weeks ]
  • Mini-Mental State Examination (MMSE) [ Time Frame: 52 weeks ]
  • Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) [ Time Frame: 52 weeks ]
  • Timed Up and Go (TUG) test [ Time Frame: 52 weeks ]
  • Epworth Sleepiness Scale (ESS) [ Time Frame: 52 weeks ]

Secondary Outcome Measures:
  • Individual Domain of the Neuropsychiatric Inventory (NPI) [ Time Frame: 52 weeks ]
  • Total NPI Score [ Time Frame: 52 weeks ]
  • Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC) Agitation (Global Clinical Status of Agitation on mADCS-CGIC Scale) [ Time Frame: 52 weeks ]
  • Zarit Burden Scale [ Time Frame: 52 weeks ]
  • Patient Global Impression of Change [ Time Frame: 52 weeks ]
  • Dementia Quality of Life [ Time Frame: 52 weeks ]
  • Resource Utilization in Dementia [ Time Frame: 52 weeks ]
  • Cohen-Mansfield Agitation Inventory (CMAI) (Agitation and Aggression on CMAI Scale) [ Time Frame: 52 weeks ]
  • Cohen-Mansfield Agitation Inventory (CMAI) [ Time Frame: 52 weeks ]
  • Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change-Overall (ADCS-CGIC-Overall) [ Time Frame: 52 weeks ]
  • Cornell Scale for Depression in Dementia (CSDD) [ Time Frame: 52 weeks ]
  • General Medical Health Rating (GMHR) [ Time Frame: 52 weeks ]
  • Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL) [ Time Frame: 52 weeks ]

Other Outcome Measures:
  • Frequency of using concomitant medications [ Time Frame: 52 weeks ]

Estimated Enrollment: 550
Study Start Date: December 2015
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AVP-786-28/4.9
Participants will be assigned to treatment with 28 milligrams (mg) of deuterated (d6)-dextromethorphan hydrobromide (d6-DM) and 4.9 mg of quinidine sulfate (Q) (AVP-786-28/4.9).
Drug: AVP-786
Experimental: AVP-786-18/4.9
Participants will be assigned to treatment with 18 milligrams (mg) of deuterated (d6)-dextromethorphan hydrobromide (d6-DM) and 4.9 mg of quinidine sulfate (Q) (AVP-786-18/4.9).
Drug: AVP-786

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 52 weeks.

Approximately 550 participants will be enrolled at approximately 110 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.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
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 Change (CGIS) score assessing Agitation of ≥ 4 (moderately ill) at 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 4 weeks preceding baseline
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02446132

Contacts
Contact: Uyen Nguyen unguyen@avanir.com
Contact: Paul Shin pshin@avanir.com

  Show 90 Study Locations
Sponsors and Collaborators
Avanir Pharmaceuticals
  More Information

Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02446132     History of Changes
Other Study ID Numbers: 15-AVP-786-303
Study First Received: May 11, 2015
Last Updated: July 21, 2016

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Dextromethorphan
Quinidine
Quinidine gluconate
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Anti-Arrhythmia Agents
Antimalarials

ClinicalTrials.gov processed this record on March 22, 2017