A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Placebo; Drug: ALKS 9072

• Registration Number: NCT01469039
• Lead Sponsor: Alkermes, Inc.

Brief Summary

The study will determine the efficacy of ALKS 9072 (also known as aripiprazole lauroxil or ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute exacerbation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-08
• Study First Submitted QC: 2011-11-08
• Study First Posted: 2011-11-10
• Study Start: 2011-12
• Primary Completion: 2014-01
• Study Completion: 2014-03
• Disposition First Submitted: 2014-04-14
• Disposition First Submitted QC: 2014-04-14
• Disposition First Posted: 2014-05-06
• Results First Submitted: 2015-11-04
• Results First Submitted QC: 2015-12-16
• Results First Posted: 2016-01-22
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 623

Inclusion Criteria

• Diagnosis of schizophrenia according to DSM-IV-TR criteria
• Has been able to achieve outpatient status for more than 3 months in the past year
• Body mass index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)
• Resides in a stable living situation
• Willing and able to be confined to an inpatient study unit for 2 weeks or longer

Exclusion Criteria

• History of poor or inadequate clinical response to treatment with aripiprazole
• History of treatment resistance
• Known or suspected intolerance of, allergy, or hypersensitivity to aripiprazole, its ingredients, other antipsychotic agent, or INTRALIPID (including peanuts, soy, egg, or glycerol)
• Diagnosis of current substance dependence (including alcohol)
• Pregnant, lactating, or breastfeeding
• Receipt of any antipsychotic medication by IM injection within 60 days before Screening
• Current involuntary hospitalization or incarceration
• Hospitalized for more than 30 days during the 90 days before Screening

Additional inclusion/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
ALKS 9072	ALKS 9072	-

Primary Outcome Measures

Name	Time	Method
The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score	Data collected from baseline to day 85	The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition.

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression - Improvement (CGI-I) Scores at Day 85	85 Days	The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the study. Results indicate participants evaluated at one of the following categories: "1: very much improved"; "2: much improved"; "3: minimally improved"; "4: no change"; "5: minimally worse"; "6: much worse"; or "7: very much worse".

Trial Locations

Locations (2)

Alkermes Investigational Site; 🇺🇦 Vinnytsya, Ukraine

Alkermes Investigational site; 🇺🇸 Leesburg, Florida, United States