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

• Status: Completed
• Trial end date: 2017-07-11
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: Aripiprazole; Aripiprazole lauroxil; Paliperidone Palmitate

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