Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) 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: NCT03393520
Recruitment Status : Recruiting
First Posted : January 8, 2018
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE January 3, 2018
First Posted Date  ICMJE January 8, 2018
Last Update Posted Date October 27, 2020
Actual Study Start Date  ICMJE October 13, 2017
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2018)
Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score [ Time Frame: Baseline; Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2020)
Change from Baseline to Week 12 in the Clinical Global Impression of Severity (CGIS)-Agitation Domain Score [ Time Frame: Baseline; Week 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2018)
  • Change from Baseline to Week 12 in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change for Agitation (mADCS-CGIC-Agitation) Score [ Time Frame: Baseline; Week 12 ]
  • Change from Baseline to Week 12 in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score [ Time Frame: Baseline; Week 12 ]
  • Change from Baseline to Week 12 in the NPI Caregiver Distress Score [ Time Frame: Baseline; Week 12 ]
  • Change from Baseline to Week 12 in the NPI Aberrant Motor Behavior Domain Score [ Time Frame: Baseline; Week 12 ]
  • Change from Baseline to Week 12 in the NPI Irritability/Lability Domain Score [ Time Frame: Baseline; Week 12 ]
  • Change from Baseline to Week 12 in the NPI Total Score [ Time Frame: Baseline; Week 12 ]
  • Change from Baseline to Week 12 in the Clinical Global Impression of Severity (CGIS)-Agitation Domain Score [ Time Frame: Baseline; Week 12 ]
  • Change from Baseline to Week 12 in the ADCS-CGIC for Overall Clinical Status Rating [ Time Frame: Baseline; Week 12 ]
  • Change from Baseline to Week 12 in the Patient Global Impression of Change (PGIC) Scale Score [ Time Frame: Baseline; Week 12 ]
  • Change from Baseline to Week 12 in the Dementia Quality of Life (DEMQOL) Scale Score [ Time Frame: Baseline; Week 12 ]
  • Change from Baseline to Week 12 in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Dimension Scores [ Time Frame: Baseline; Week 12 ]
  • Change from Baseline to Week 12 in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score [ Time Frame: Baseline; Week 12 ]
  • Change from Baseline to Week 12 in the Resource Utilization in Dementia (RUD) Scale Score [ Time Frame: Baseline; Week 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Official Title  ICMJE A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Brief Summary This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.
Detailed Description

Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD.

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-design study, consisting of 12 weeks of treatment.

Approximately 550 participants will be enrolled at approximately 90 centers worldwide.

Study medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Agitation in Patients With Dementia of the Alzheimer's Type
Intervention  ICMJE
  • Drug: Placebo
    oral capsules
  • Drug: AVP-786
    oral capsules
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.
    Intervention: Drug: Placebo
  • Experimental: AVP-786; Dose 1
    Participants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.
    Intervention: Drug: AVP-786
  • Experimental: AVP-786; Dose 2
    Participants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.
    Intervention: Drug: AVP-786
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 31, 2020)
550
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2018)
412
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria
  • Participants with clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to baseline that interferes with their daily routine and for which a prescription medication has been indicated, in the opinion of the investigator
  • The diagnosis of agitation must meet the provisional consensus definition of agitation in participants with cognitive disorders developed by the International Psychogeriatric Association (IPA) Agitation Definition Work Group.
  • A Clinical Global Impression of Severity of Illness scale for Agitation (CGIS-Agitation) score of ≥ 4 (moderately ill) at screening and baseline
  • Participants must have a reliable caregiver who is able and willing to comply with study procedures, including not administering any prohibited medications during the course of the study.
  • Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.

Exclusion Criteria:

  • Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
  • Participants with symptoms of agitation that are not secondary to AD (e.g., secondary to pain, other psychiatric disorder, or delirium)
  • 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 with myasthenia gravis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Fred Ledon +1 949 389-6724 FLedon@avanir.com
Contact: Caroline Mason +44 (00) 7551 125 782 CMason@Otsuka-Europe.com
Listed Location Countries  ICMJE Australia,   Bulgaria,   Czechia,   France,   Hungary,   Italy,   Poland,   South Africa,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03393520
Other Study ID Numbers  ICMJE 17-AVP-786-305
2017-001339-38 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Avanir Pharmaceuticals
Study Sponsor  ICMJE Avanir Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Avanir Pharmaceuticals
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP