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 Treatmentof Agitation in Patients with Dementia of the Alzheimer’s Type

Avanir Pharmaceuticals, Inc.0 sites1,000 target enrollmentFebruary 27, 2019

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Avanir Pharmaceuticals, Inc.
Enrollment: 1000
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 27, 2019

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Avanir Pharmaceuticals, Inc.

Eligibility Criteria

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 consentform (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:

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.