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: 20.0 Level: PT Classification code 10001497 Term: Agitation System Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-002455-29-ES
• Lead Sponsor: Avanir Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-07
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 1000

Inclusion Criteria

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 for enrollment by the investigator after review of the inclusion/exclusion criteria.

Patient has stable cardiac, pulmonary, hepatic, and renal function.

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.

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.

Caregiver must be willing and able to comply with study procedures, including not administering any prohibited medications during the course of the study.

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

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.

Caregiver is unwilling or unable, in the opinion of the investigator, to comply with study instructions.

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).

Patients determined to have a high imminent risk of falls during the study based on a clinical evaluation by the investigator

Patients who are currently using or were on NUEDEXTA® in the 2 weeks preceding Baseline.

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
Main Objective: Evaluation of the long-term safety and maintenance of efficacy of AVP-786 for the treatment of agitation in patients with dementia of the Alzheimer’s type.;Secondary Objective: None;Primary end point(s): SAFETY: Safety and tolerability of AVP-786 will be assessed by reported adverse events (AEs), physical and neurological examinations, vital signs, clinical laboratory assessments, resting 12-lead electrocardiograms (ECGs), Sheehan Suicidality Tracking Scale (S-STS), Mini Mental State Examination (MMSE), and the Epworth Sleepiness Scale (ESS). Pregnancy tests will be conducted for females of childbearing potential.;Timepoint(s) of evaluation of this end point: AE (every visit), PE (Baseline and V8), VS (every visit minus f/u), CLA (Baseline, V2, V3, V4, V5, V6, V7, V8), ECG (Baseline, V2, V3, V4, V5, V6, V7, V8), S-STS (All visits), MMSE (Baseline, V5 and V8), ESS (Baseline, V5 and V8), Pregnancy (Baseline, V2, V3, V4, V5, V6, V7, V8).