Summary

for people ages 50-90 (full criteria)
at San Diego, California and other locations
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

  • VA San Diego Healthcare System accepting new patients
    San Diego California 92103 United States
  • Pacific Research Network, Inc. accepting new patients
    San Diego California 92103 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