Clinical trial NCT02634320: A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia
Official title: Safety and Tolerability of Initiating Aripiprazole Lauroxil in Subjects With Schizophrenia Who Are Inadequately Treated With Paliperidone Palmitate or Risperidone Long Acting Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Alkermes
ARISTADA
Aripiprazole Lauroxil
Schizophrenia
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2015-12-18
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and tolerability of aripiprazole lauroxil (also known as ARISTADA, ALKS 9070).


Eligibility criteria: Inclusion Criteria:

* Has demonstrated tolerability to test doses of oral aripiprazole during screening; OR has a history of tolerated use of aripiprazole
* Has a diagnosis of schizophrenia
* Is clinically stable
* Has received at least 3 doses of risperidone long acting injection (Risperdal Consta) or paliperidone palmitate (Invega Sustenna) prior to screening.
* Has no antipsychotic medication regimen change for 4 weeks prior to Day 1
* Agreed to abide by the contraceptive requirements o the protocol
* Resides in a stable living situation
* Additional criteria may apply

Exclusion Criteria:

* Is currently pregnant or breastfeeding, or is planning to become pregnant during the study
* Has received Invega Trinza, aripiprazole lauroxil, or IM depot aripiprazole within 6 months of screening
* Has participated in a clinical trial involving any investigational product within the past 3 months, or is currently participating in a clinical trial involving an investigational product
* Has a positive urine drug test for illicit use of amphetamines, barbiturates, cocaine, methadone, opiates, phencyclidine at screening
* Additional criteria may apply

Primary outcomes:
measure: Change From Baseline to Last Treatment Visit in Clinical Global Impressions-Severity (CGI-S) Scores
timeFrame: Up to 7 months
Secondary outcomes:
measure: Change From Baseline to Last Treatment Visit in Brief Psychiatric Rating Scale (BPRS) Scores
timeFrame: Up to 7 months
measure: Number of Participants With Adverse Events
timeFrame: Up to 7 months
measure: Daily and Social Functioning Will be Measured Using the Heinrichs-Carpenter Quality of Life Scale (QLS)
timeFrame: Up to 7 months
measure: Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6)
timeFrame: Up to 7 months
measure: Characterization of Family Burden Will be Measured Using the Burden Assessment Scale (BAS)
timeFrame: Up to 7 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Alkermes Investigational Site
state: Arkansas
city: Rogers
country: United States
facility: Alkermes Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: Alkermes Investigational Site
state: California
city: Culver City
country: United States
facility: Alkermes Investigational Site
state: California
city: Garden Grove
country: United States
facility: Alkermes Investigational Site
state: California
city: National City
country: United States
facility: Alkermes Investigational Site
state: California
city: Oceanside
country: United States
facility: Alkermes Investigational Site
state: California
city: Orange
country: United States
facility: Alkermes Investigational Site
state: California
city: Panorama City
country: United States
facility: Alkermes Investigational Site
state: California
city: Augusta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Shreveport
country: United States
facility: Alkermes Investigational Site
state: Louisiana
city: Saint Louis
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Garfield Heights
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Lincoln
country: United States
facility: Alkermes Investigational Site
state: Rhode Island
city: Dallas
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Dallas
country: United States
facility: Alkermes Investigational Site
state: Texas
city: DeSoto
country: United States
facility: Alkermes Investigational Site
state: Texas
Study officials:
affiliation: Alkermes, Inc.
name: Sanjeev Pathak, MD
role: STUDY_DIRECTOR
References: