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

Alkermes

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Aripiprazole Lauroxil

Study type: Interventional

Funder types: Industry

Identifiers

NCT02634320

ALK9072-A401

Details and patient eligibility

About

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

Enrollment: 51 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Aripiprazole Lauroxil

Other group

Description:

Intramuscular (IM) injection

Treatment:

Drug: Aripiprazole Lauroxil