Trial record 4 of 24 for:    avanir

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 April 2016 by Avanir Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02446132
First received: May 11, 2015
Last updated: April 1, 2016
Last verified: April 2016
  Purpose
This is an extension study of the Phase 3 Studies 15-AVP-786-301 and 15-AVP-786-302, which also allows patients 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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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, SAE [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Safety and Tolerability

  • Clinical Laboratory Assessments [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Safety

  • 12-lead electrocardiograms (ECGs) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Safety


Secondary Outcome Measures:
  • Individual Domain of the Neuropsychiatric Inventory (NPI) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Efficacy

  • Total Neuropsychiatric Inventory (NPI) Score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Efficacy

  • Modified Clinical Global Impression of Change-Agitation (Global Clinical Status of Agitation on mADCS-CGIC Scale) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Efficacy

  • Zarit Burdent Scale [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Efficacy

  • Patient Global Impression of Change [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Efficacy

  • Dementia Quality of Life [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Efficacy

  • Resource Utilization in Dementia [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Efficacy

  • Cohen-Mansfield Agitation Inventory (Agitation and Aggression on CMAI Scale) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Efficacy


Other Outcome Measures:
  • Frequency of using concomitant medications [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Cocomitant Medications


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
AVP-786 (dose 1 and dose 2)
Patients will be assigned to treatment with AVP-786 dose 1 or AVP-786 dose 2
Drug: AVP-786

Detailed Description:

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

Patients will be enrolled in the study for approximately 52 weeks.

Approximately 550 patients will be enrolled at approximately 110 centers in the US.

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

  Eligibility

Ages Eligible for Study:   50 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, or 12-AVR-131.
  • Patients from Study 12-AVR-131 with a diagnosis of probable AD according to the 2011 NIA-AA working group criteria.
  • Either out-patients or residents of an assisted-living facility or a skilled nursing home.
  • Patients from Study 12-AVR-131 who have clinically significant, moderate/severe agitation at least 2 weeks prior to baseline.
  • Patients from Study 12-AVR-131 with a diagnosis of agitation that must meet the IPA provisional definition of agitation.
  • Patients from Study 12-AVR-131 with a CGIS score assessing Agitation of ≥ 4 (moderately ill) at baseline.
  • Patients from Study 12-AVR-131 with a MMSE score between 6 and 26 (inclusive) at baseline.

Exclusion Criteria:

  • Patients 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).
  • Patients determined to have a high imminent risk of falls during the study based on a clinical evaluation by the investigator.
  • Patients 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

Locations
United States, California
Recruiting
Temecula, California, United States, 92591
United States, Florida
Recruiting
Brooksville, Florida, United States, 34601
Recruiting
Lake Worth, Florida, United States, 33449
Recruiting
The Villages, Florida, United States, 32162
United States, Georgia
Recruiting
Columbus, Georgia, United States, 31909
United States, New Jersey
Recruiting
Toms River, New Jersey, United States, 08755
United States, New York
Recruiting
Brooklyn, New York, United States, 11229
Recruiting
Orangeburg, New York, United States, 10962
United States, Ohio
Recruiting
Centerville, Ohio, United States, 45459
United States, Pennsylvania
Recruiting
Willow Grove, Pennsylvania, United States, 19090
United States, Vermont
Recruiting
Woodstock, Vermont, United States, 05091
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: April 1, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Dyskinesias
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurodegenerative Diseases
Neurologic Manifestations
Psychomotor Disorders
Signs and Symptoms
Tauopathies
Dextromethorphan
Quinidine
Quinidine gluconate
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-Antagonists
Anti-Arrhythmia Agents
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Antitussive Agents
Cardiovascular Agents
Central Nervous System Agents
Cholinergic Agents

ClinicalTrials.gov processed this record on April 27, 2016