Summary

for people ages 50-90 (full criteria)
at UC IrvineUCSD
study started
estimated completion

Description

Summary

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.

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

Details

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 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 700 participants will be enrolled at approximately 135 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.

Keywords

Agitation in Patients With Dementia of the Alzheimer's Type Dementia Psychomotor Agitation Alzheimer Disease Dextromethorphan AVP-786 AVP-786 (dose 1) AVP-786 (dose 2) AVP-786 (dose 3)

Eligibility

You can join if…

Open to people ages 50-90

  • 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 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

You CAN'T join if...

  • 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

Locations

  • University of California, Irvine not yet accepting patients
    Irvine California 92697 United States
  • VA San Diego Healthcare System accepting new patients
    San Diego California 92103 United States
  • Irvine Center for Clinical Research accepting new patients
    Irvine California 92614 United States
  • Shankle Clinic withdrawn
    Newport Beach California 92663 United States
  • HB Clinical Trials Inc. not yet accepting patients
    Santa Ana California 92704 United States
  • New Foundation Medical Group Clinical Trials not yet accepting patients
    Tustin California 92780 United States
  • Pacific Research Network, Inc. accepting new patients
    San Diego California 92103 United States
  • Syrentis Clinical Research accepting new patients
    Santa Ana California 92705 United States
  • NRC Research Institute accepting new patients
    Orange California 92868 United States
  • California Neurological Services not yet accepting patients
    Panorama City California 91402 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Avanir Pharmaceuticals
ID
NCT02446132
Phase
Phase 3
Study Type
Interventional
Last Updated