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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 : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE May 11, 2015
First Posted Date  ICMJE May 18, 2015
Last Update Posted Date November 7, 2019
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2019)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 14, 2015)
  • Treatment Emergent Adverse Event, SAE [ Time Frame: 52 weeks ]
    Safety and Tolerability
  • Clinical Laboratory Assessments [ Time Frame: 52 weeks ]
    Safety
  • 12-lead Electrocardiograms (ECGs) [ Time Frame: 52 weeks ]
    Safety
Change History Complete list of historical versions of study NCT02446132 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2019)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2015)
  • Individual Domain of the Neuropsychiatric Inventory (NPI) [ Time Frame: 52 weeks ]
    Efficacy
  • Total Neuropsychiatric Inventory (NPI) Score [ Time Frame: 52 weeks ]
    Efficacy
  • Clinical Global Impression of Change-Agitation [ Time Frame: 52 weeks ]
    Efficacy
  • Zarit Burdent Scale [ Time Frame: 52 weeks ]
    Efficacy
  • Patient Global Impression of Change [ Time Frame: 52 weeks ]
    Efficacy
  • Dementia Quality of Life [ Time Frame: 52 weeks ]
    Efficacy
  • Resource Utilization in Dementia [ Time Frame: 52 weeks ]
    Efficacy
  • EuroQol 5-Dimension 5-Level [ Time Frame: 52 weeks ]
    Efficacy
Current Other Pre-specified Outcome Measures
 (submitted: April 17, 2017)
Number of participants using concomitant medications [ Time Frame: up to 64 weeks ]
Original Other Pre-specified Outcome Measures
 (submitted: May 14, 2015)
Frequency of using concomitant medications [ Time Frame: 52 weeks ]
Cocomitant Medications
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary This is an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305, which also allows participants from the Phase 2 Study 12-AVR-131 to be included.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Agitation in Patients With Dementia of the Alzheimer's Type
Intervention  ICMJE Drug: AVP-786
Study Arms  ICMJE
  • Experimental: AVP-786 (dose 1)
    AVP-786 dose 1; capsules administered twice a day over a 52-week period
    Intervention: Drug: AVP-786
  • Experimental: AVP-786 (dose 2)
    AVP-786 dose 2; capsules administered twice a day over a 52-week period
    Intervention: Drug: AVP-786
  • Experimental: AVP-786 (dose 3)
    AVP-786 dose 3; capsules administered twice a day over a 52-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: October 24, 2019)
1000
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2015)
550
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 949-389-6724 fledon@avanir.com
Contact: Nadine Knowles 949-268-8972 nknowles@avanir.com
Listed Location Countries  ICMJE Bulgaria,   Canada,   Czechia,   France,   Hungary,   Italy,   Poland,   South Africa,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02446132
Other Study ID Numbers  ICMJE 15-AVP-786-303
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 November 2019

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