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

Investigator: Elizabeth Crocco

Institutional Protocol #: 20150934

National Clinical Trials Identifier: NCT02446132

Funding Agency/Sponsor: Avanir Pharmaceuticals/ Inc.

Division: Psychiatry

Therapeutic Area: Other

Phase: Phase III

Enrolling Sites: University of Miami Medical Group

Enrolling Since: 7/29/2016


Purpose/Abstract:


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.




Eligibility Criteria:


Inclusion Criteria:

- 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

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


Gender: All

Minimum Age: 50 Years

Maximum Age: 90 Years

Accepts healthy volunteers: No

Please note that this is written for scientific review, and if there are any questions or clarifications needed, please contact

Belinda Robertson, Clinical Research Coordinator
(305) 243 2891
b.ryan1@miami.edu

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