Extension Study of AVP-786 in the Treatment of Subjects with Agitation Associated with Dementia of the Alzheimer's Type

Phase 1

Conditions: Agitation Associated with Dementia of the Alzheimer's Type
MedDRA version: 20.0Level: PTClassification code 10001497Term: AgitationSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2017-002455-29-HU

Lead Sponsor: Avanir Pharmaceuticals, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 1200

Inclusion Criteria

1. Patient has successfully completed Studies 15-AVP-786 301, 15-AVP-
786-302, 17-AVP-786-305, or 12-AVR-131 and is deemed eligible
forenrollment by the investigator after review of theinclusion/exclusion
criteria.
8. Patient has stable cardiac, pulmonary, hepatic, and renal function.
10. If female of childbearing potential, must have been practicing a
medically-acceptable method of birth control and continue with the same
method during the entire study duration (oral contraceptive tablets,
hormonal implant device, hormone patch, intrauterine device, diaphragm
and contraceptive cream or foam, condom with spermicide, or
abstinence) or be surgically sterile or post-menopausal.
15. Patients from Study 12-AVR-131 must not show current and
significant symptoms of a depressive disorder and must have a score
<10 in the Cornell Scale for Depression in Dementia (CSDD) at Screening
for. Patients rolling over from Studies 15-AVP-786-301, 15-AVP-786-
302, and 17-AVP-786-305 with scores greater than 10 in the CSDD at
baseline should be evaluated by the investigator for enrollment in the
current study.
17. Caregiver must be willing and able to comply with study procedures,
including not administering any prohibited medications during the
course of the study.
18. Patient/caregiver must be willing to sign and receive a copy of
patient/caregiver informed consent form (ICF) after the nature and risks of study participation have been fully explained. Patients who are not
capable of signing the ICF but are able to provide assent, or the patient's
authorized representative agrees to participation (for patients unable to
provide assent) are allowed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 750

Exclusion Criteria

1. Patient is currently participating in, or has participated in other
interventional (drug or device)
clinical study since exiting Studies 15-AVP-786-301, 15-AVP-786-302,
and 17-AVP-786-305, or within 30 days prior to baseline for patients
from Study 12-AVR-131.
2. Caregiver is unwilling or unable, in the opinion of the investigator, to
comply with study instructions.
3. Patients with co-existent clinically significant or unstable systemic
diseases that could confound
the interpretation of the safety results of the study (e.g., malignancy
[except skin basal-cell carcinoma or untreated prostate cancer], poorly
controlled diabetes, poorly controlled hypertension, unstable pulmonary,
renal or hepatic disease, unstable ischemic cardiac disease, dilated
cardiomyopathy, or unstable valvular heart disease). Certain other
nonmetastatic cancer
may be allowed. For patients from Study 12-AVR-131, each case to be
evaluated individually with the Medical Monitor (MM).
4. Patients determined to have a high imminent risk of falls during the
study based on a clinical evaluation by the investigator
6. Patients who are currently using or were on NUEDEXTA® in the 2
weeks preceding Baseline.
7. Patients with evidence of serious risk of suicide at Screening (patients
from Study 12-AVR-131) and Baseline based on the Sheehan Suicidality
Tracking Scale (S-STS), i.e., a score of 3 or 4 on any one question 2
through 6 or 11 or a score of 2 or higher on any one questions 1a, 7
through 10, or 12, or who, in the opinion of the investigator, present a
serious risk of suicide.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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