A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia

Completed · Phase 4

Conditions studied: Schizophrenia

In brief

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

Key facts

Study ID

NCT02634320

Run by

Alkermes, Inc.

People needed

51

Starts

2015-12-01

Expected to finish

2017-07-11

Last updated by the study team

2018-12-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alkermes Investigational Site — Little Rock, Arkansas, United States
• Alkermes Investigational Site — Rogers, Arkansas, United States
• Alkermes Investigational Site — Anaheim, California, United States
• Alkermes Investigational Site — Culver City, California, United States
• Alkermes Investigational Site — Garden Grove, California, United States
• Alkermes Investigational Site — National City, California, United States
• Alkermes Investigational Site — Oceanside, California, United States
• Alkermes Investigational Site — Orange, California, United States
• Alkermes Investigational Site — Panorama City, California, United States
• Alkermes Investigational Site — Augusta, Georgia, United States
• Alkermes Investigational Site — Chicago, Illinois, United States
• Alkermes Investigational Site — Shreveport, Louisiana, United States
• Alkermes Investigational Site — St Louis, Missouri, United States
• Alkermes Investigational Site — Garfield Heights, Ohio, United States
• Alkermes Investigational Site — Lincoln, Rhode Island, United States
• Alkermes Investigational Site — Dallas, Texas, United States
• Alkermes Investigational Site — Dallas, Texas, United States
• Alkermes Investigational Site — DeSoto, Texas, United States

Full record on ClinicalTrials.gov

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