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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ALKS 9072
Placebo
Sponsored by
Alkermes, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Alkermes, schizophrenia, ALKS 9072, ALKS 9070, aripiprazole lauroxil

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site
  • Alkermes Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ALKS 9072

Placebo

Arm Description

Outcomes

Primary Outcome Measures

The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score
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

Clinical Global Impression - Improvement (CGI-I) Scores at Day 85
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".

Full Information

First Posted
November 8, 2011
Last Updated
January 14, 2019
Sponsor
Alkermes, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01469039
Brief Title
A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia
Official Title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of ALKS 9072 in Subjects With Acute Exacerbation of Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alkermes, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Alkermes, schizophrenia, ALKS 9072, ALKS 9070, aripiprazole lauroxil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
623 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALKS 9072
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ALKS 9072
Intervention Description
Intramuscular (IM) injection, 441 mg or 882 mg given monthly
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for IM injection, given monthly
Primary Outcome Measure Information:
Title
The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score
Description
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.
Time Frame
Data collected from baseline to day 85
Secondary Outcome Measure Information:
Title
Clinical Global Impression - Improvement (CGI-I) Scores at Day 85
Description
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".
Time Frame
85 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alkermes Medical Director
Organizational Affiliation
Alkermes, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Alkermes Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72201
Country
United States
Facility Name
Alkermes Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Alkermes Investigational Site
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72764
Country
United States
Facility Name
Alkermes Investigational Site
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Alkermes Investigational Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Alkermes Investigational Site
City
La Habra
State/Province
California
ZIP/Postal Code
90631
Country
United States
Facility Name
Alkermes Investigational Site
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
Alkermes Investigational Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Alkermes Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Alkermes Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Alkermes Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Alkermes Investigational Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Alkermes Investigational site
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Alkermes Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Alkermes Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Alkermes Investigational Site
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Alkermes Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Alkermes Investigational Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Alkermes Investigational Site
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Alkermes Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
Facility Name
Alkermes Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Alkermes Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Alkermes Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Alkermes Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
Alkermes Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Alkermes Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Alkermes Investigational Site
City
Burgas
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Kazanlak
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Novi Iskar
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Pazardzhik
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Pleven
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Plovdiv
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Radnevo
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Ruse
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Sofia
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Stara Zagora
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Targovishte
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Veliko Tarnovo
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Vratsa
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Jeju-si
Country
Korea, Republic of
Facility Name
Alkermes Investigational Site
City
Jeollanam-do
Country
Korea, Republic of
Facility Name
Alkermes Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
Alkermes Investigational Site
City
Cheras
Country
Malaysia
Facility Name
Alkermes Investigational Site
City
Johor Bahru
Country
Malaysia
Facility Name
Alkermes Investigational Site
City
Kuala Lumpur
Country
Malaysia
Facility Name
Alkermes Investigational Site
City
Kuching
Country
Malaysia
Facility Name
Alkermes Investigational Site
City
Mariveles
State/Province
Bataan
Country
Philippines
Facility Name
Alkermes Investigational Site
City
Cebu City
Country
Philippines
Facility Name
Alkermes Investigational Site
City
Iloilo City
Country
Philippines
Facility Name
Alkermes Investigational Site
City
Mandaluyong City
Country
Philippines
Facility Name
Alkermes Investigational Site
City
Manila
Country
Philippines
Facility Name
Alkermes Investigational Site
City
Pasig City
Country
Philippines
Facility Name
Alkermes Investigational Site
City
Oradea
State/Province
Bihor
Country
Romania
Facility Name
Alkermes Investigational Site
City
Bucharest
ZIP/Postal Code
030455
Country
Romania
Facility Name
Alkermes Investigational Site
City
Bucharest
Country
Romania
Facility Name
Alkermes Investigational Site
City
Craiova
Country
Romania
Facility Name
Alkermes Investigational Site
City
Iasi
Country
Romania
Facility Name
Alkermes Investigational Site
City
Targu Mures
Country
Romania
Facility Name
Alkermes Investigational Site
City
Nikol'skoye
State/Province
Gatchinckiy
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Staritsa
State/Province
Orenburg
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Talagi
State/Province
Primorsky
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Khotkovo
State/Province
Sergievo-Posadskiy
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Lipetsk
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Nizhniy Novgorod
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Rostov-on-Don
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Samara
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Saratov
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Stavropol
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Voronezh
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Yaroslavl
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Stepanovka
State/Province
Kherson
Country
Ukraine
Facility Name
Alkermes Investigational Site
City
Chernigiv
Country
Ukraine
Facility Name
Alkermes Investigational Site
City
Donetsk
Country
Ukraine
Facility Name
Alkermes Investigational Site
City
Kharkiv
Country
Ukraine
Facility Name
Alkermes Investigational Site
City
Kyiv
Country
Ukraine
Facility Name
Alkermes Investigational Site
City
Lugansk
Country
Ukraine
Facility Name
Alkermes Investigational Site
City
Lviv
Country
Ukraine
Facility Name
Alkermes Investigational Site
City
Poltava
Country
Ukraine
Facility Name
Alkermes Investigational Site
City
Simferopol
Country
Ukraine
Facility Name
Alkermes Investigational Site
City
Ternopil
Country
Ukraine
Facility Name
Alkermes Investigational Site
City
Uzhgorod
Country
Ukraine
Facility Name
Alkermes Investigational Site
City
Vinnytsya
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
27707530
Citation
Targum SD, Risinger R, Du Y, Pendergrass JC, Jamal HH, Silverman BL. Effect of patient age on treatment response in a study of the acute exacerbation of psychosis in schizophrenia. Schizophr Res. 2017 Jan;179:64-69. doi: 10.1016/j.schres.2016.09.034. Epub 2016 Oct 1.
Results Reference
result
PubMed Identifier
27574838
Citation
Nasrallah HA, Newcomer JW, Risinger R, Du Y, Zummo J, Bose A, Stankovic S, Silverman BL, Ehrich EW. Effect of Aripiprazole Lauroxil on Metabolic and Endocrine Profiles and Related Safety Considerations Among Patients With Acute Schizophrenia. J Clin Psychiatry. 2016 Nov;77(11):1519-1525. doi: 10.4088/JCP.15m10467.
Results Reference
result
PubMed Identifier
26517202
Citation
Citrome L, Du Y, Risinger R, Stankovic S, Claxton A, Zummo J, Bose A, Silverman BL, Ehrich EW. Effect of aripiprazole lauroxil on agitation and hostility in patients with schizophrenia. Int Clin Psychopharmacol. 2016 Mar;31(2):69-75. doi: 10.1097/YIC.0000000000000106.
Results Reference
result
PubMed Identifier
26114240
Citation
Meltzer HY, Risinger R, Nasrallah HA, Du Y, Zummo J, Corey L, Bose A, Stankovic S, Silverman BL, Ehrich EW. A randomized, double-blind, placebo-controlled trial of aripiprazole lauroxil in acute exacerbation of schizophrenia. J Clin Psychiatry. 2015 Aug;76(8):1085-90. doi: 10.4088/JCP.14m09741.
Results Reference
result
PubMed Identifier
28342578
Citation
Potkin SG, Risinger R, Du Y, Zummo J, Bose A, Silverman B, Stankovic S, Ehrich E. Efficacy and safety of aripiprazole lauroxil in schizophrenic patients presenting with severe psychotic symptoms during an acute exacerbation. Schizophr Res. 2017 Dec;190:115-120. doi: 10.1016/j.schres.2017.03.003. Epub 2017 Mar 23.
Results Reference
result
PubMed Identifier
28712616
Citation
Cameron C, Zummo J, Desai DN, Drake C, Hutton B, Kotb A, Weiden PJ. Aripiprazole Lauroxil Compared with Paliperidone Palmitate in Patients with Schizophrenia: An Indirect Treatment Comparison. Value Health. 2017 Jul-Aug;20(7):876-885. doi: 10.1016/j.jval.2017.03.010. Epub 2017 May 9.
Results Reference
result
PubMed Identifier
28625204
Citation
Citrome L, Risinger R, Cutler AJ, Du Y, Zummo J, Nasrallah HA, Silverman BL. Effect of aripiprazole lauroxil in patients with acute schizophrenia as assessed by the Positive and Negative Syndrome Scale-supportive analyses from a Phase 3 study. CNS Spectr. 2018 Aug;23(4):284-290. doi: 10.1017/S1092852917000396. Epub 2017 Jun 19.
Results Reference
result
PubMed Identifier
28350572
Citation
Hard ML, Mills RJ, Sadler BM, Turncliff RZ, Citrome L. Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia. J Clin Psychopharmacol. 2017 Jun;37(3):289-295. doi: 10.1097/JCP.0000000000000691.
Results Reference
result
PubMed Identifier
29179595
Citation
Cameron C, Zummo J, Desai D, Drake C, Hutton B, Kotb A, Weiden PJ. Efficacy and safety of aripiprazole lauroxil once-monthly versus aripiprazole once-monthly long-acting injectable formulations in patients with acute symptoms of schizophrenia: an indirect comparison of two double-blind placebo-controlled studies. Curr Med Res Opin. 2018 Apr;34(4):725-733. doi: 10.1080/03007995.2017.1410471. Epub 2018 Jan 10.
Results Reference
result
PubMed Identifier
28937706
Citation
McEvoy JP, Risinger R, Mykhnyak S, Du Y, Liu CC, Stanford AD, Weiden PJ. Durability of Therapeutic Response With Long-Term Aripiprazole Lauroxil Treatment Following Successful Resolution of an Acute Episode of Schizophrenia. J Clin Psychiatry. 2017 Sep-Oct;78(8):1103-1109. doi: 10.4088/JCP.17m11625.
Results Reference
derived
Links:
URL
http://grls.rosminzdrav.ru
Description
Russian clinical trials website
URL
http://www.clinicaltrialsregister.eu
Description
EU Clinical Trials Register; EudraCT number 2012-003445-15

Learn more about this trial

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

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