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A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)

Primary Purpose

Schizophrenia

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

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

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

Inclusion Criteria:

(Subjects who participated in ALK9072-003)

  • Completed the ALK9072-003 Day 85 visit
  • Continues to require treatment with an antipsychotic medication

(New Subjects)

  • On a stable dose of oral antipsychotic medication
  • Diagnosis of chronic schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria that is clinically stable
  • Has been able to achieve outpatient status for more than 3 months prior to screening
  • Body Mass Index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)
  • Resides in a stable living situation

Exclusion Criteria:

(Subjects who participated in ALK9072-003)

  • Abnormal clinical laboratory, vital sign, or electrocardiogram (ECG) finding during participation in study ALK9072-003 that was clinically relevant and related to study drug
  • Missed more than 1 scheduled study visit during participation in study ALK9072-003
  • Has a significant or unstable medical condition that would preclude safe completion of the current study
  • Subject is pregnant or breastfeeding
  • Subject expects to be incarcerated in the next 12 months, or has pending legal action which may impact compliance with study participation or procedures

(New Subjects)

  • History of poor or inadequate clinical response to treatment with aripiprazole
  • History of treatment resistance
  • Diagnosis of current substance dependence (including alcohol)
  • Pregnant, lactating, or breastfeeding
  • Has received any long-acting intramuscular antipsychotic medication within 60 days prior to screening
  • Currently under involuntary hospitalization
  • Current or expected incarceration

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ALKS 9072, Low

ALKS 9072, High

Arm Description

Outcomes

Primary Outcome Measures

Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
This measure includes incidences >5%.

Secondary Outcome Measures

Mean Change From Baseline to Endpoint in Clinical Global Impression Scale for Severity (CGI-S)
The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients". Results indicate a change in CGI-S score from baseline to Day 365 based on the observed data.
Discontinuation From Study Due to Adverse Events (AEs)
Number of subjects who discontinued the study due to AE.
Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a questionnaire used for suicide assessment. Subjects are asked a series of questions that determine whether or not the patient demonstrates any suicidal ideation or behavior. The C-SSRS was administered to subjects at each study visit.
Incidence of Clinically Significant Changes Will be Calculated for Movement Disorders, Vital Signs and Routine Laboratory Tests
Includes incidence >2% but <5%.
Mean Change From Baseline to Endpoint Using the Positive and Negative Symptom Scale (PANSS) Total Score and Subscale Scores
This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale), 7 (positive/negative subscales), and 16 (general subscale); maximum scores (worst outcome) equals 210 (total scale), 49 (positive/negative subscales), and 112 (general subscale).

Full Information

First Posted
June 15, 2012
Last Updated
August 28, 2018
Sponsor
Alkermes, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01626456
Brief Title
A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
Official Title
A Phase 3, Multicenter, Extension of Study ALK9072-003 to Assess the Long-term Safety and Durability of Effect of ALKS 9072 in Subjects With Stable Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the safety and durability of effect of ALKS 9072 (also known as ALKS 9070) during long-term treatment of subjects with stable schizophrenia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
478 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALKS 9072, Low
Arm Type
Experimental
Arm Title
ALKS 9072, High
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ALKS 9072, Low
Intervention Description
IM injection, given monthly
Intervention Type
Drug
Intervention Name(s)
ALKS 9072, High
Intervention Description
IM injection, given monthly
Primary Outcome Measure Information:
Title
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Description
This measure includes incidences >5%.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Mean Change From Baseline to Endpoint in Clinical Global Impression Scale for Severity (CGI-S)
Description
The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients". Results indicate a change in CGI-S score from baseline to Day 365 based on the observed data.
Time Frame
52 weeks
Title
Discontinuation From Study Due to Adverse Events (AEs)
Description
Number of subjects who discontinued the study due to AE.
Time Frame
52 weeks
Title
Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Description
The C-SSRS is a questionnaire used for suicide assessment. Subjects are asked a series of questions that determine whether or not the patient demonstrates any suicidal ideation or behavior. The C-SSRS was administered to subjects at each study visit.
Time Frame
52 weeks
Title
Incidence of Clinically Significant Changes Will be Calculated for Movement Disorders, Vital Signs and Routine Laboratory Tests
Description
Includes incidence >2% but <5%.
Time Frame
52 weeks
Title
Mean Change From Baseline to Endpoint Using the Positive and Negative Symptom Scale (PANSS) Total Score and Subscale Scores
Description
This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale), 7 (positive/negative subscales), and 16 (general subscale); maximum scores (worst outcome) equals 210 (total scale), 49 (positive/negative subscales), and 112 (general subscale).
Time Frame
52 weeks

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: (Subjects who participated in ALK9072-003) Completed the ALK9072-003 Day 85 visit Continues to require treatment with an antipsychotic medication (New Subjects) On a stable dose of oral antipsychotic medication Diagnosis of chronic schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria that is clinically stable Has been able to achieve outpatient status for more than 3 months prior to screening Body Mass Index (BMI) of 18.5 to 40.0 kg/m2 (inclusive) Resides in a stable living situation Exclusion Criteria: (Subjects who participated in ALK9072-003) Abnormal clinical laboratory, vital sign, or electrocardiogram (ECG) finding during participation in study ALK9072-003 that was clinically relevant and related to study drug Missed more than 1 scheduled study visit during participation in study ALK9072-003 Has a significant or unstable medical condition that would preclude safe completion of the current study Subject is pregnant or breastfeeding Subject expects to be incarcerated in the next 12 months, or has pending legal action which may impact compliance with study participation or procedures (New Subjects) History of poor or inadequate clinical response to treatment with aripiprazole History of treatment resistance Diagnosis of current substance dependence (including alcohol) Pregnant, lactating, or breastfeeding Has received any long-acting intramuscular antipsychotic medication within 60 days prior to screening Currently under involuntary hospitalization Current or expected incarceration 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
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
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
60611
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
Targu Mures
State/Province
Mures
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
Oradea
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
Khotkovo
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
Talagi
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
Vinnytsia
Country
Ukraine

12. IPD Sharing Statement

Citations:
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
33761928
Citation
McEvoy JP, Weiden PJ, Lysaker PH, Sun X, O'Sullivan AK. Long-term effect of aripiprazole lauroxil on health-related quality of life in patients with schizophrenia. BMC Psychiatry. 2021 Mar 24;21(1):164. doi: 10.1186/s12888-021-03124-2.
Results Reference
derived
PubMed Identifier
32841554
Citation
Lauriello J, Claxton A, Du Y, Weiden PJ. Beyond 52-Week Long-Term Safety: Long-Term Outcomes of Aripiprazole Lauroxil for Patients With Schizophrenia Continuing in an Extension Study. J Clin Psychiatry. 2020 Aug 18;81(5):19m12835. doi: 10.4088/JCP.19m12835.
Results Reference
derived
PubMed Identifier
30109845
Citation
Nasrallah HA, Aquila R, Du Y, Stanford AD, Claxton A, Weiden PJ. Long-term safety and tolerability of aripiprazole lauroxil in patients with schizophrenia. CNS Spectr. 2019 Aug;24(4):395-403. doi: 10.1017/S1092852918001104. Epub 2018 Aug 15.
Results Reference
derived
PubMed Identifier
29941057
Citation
Weiden PJ, Du Y, Liu CC, Stanford AD. Switching stable patients with schizophrenia from their oral antipsychotics to aripiprazole lauroxil: a post hoc safety analysis of the initial 12-week crossover period. CNS Spectr. 2019 Aug;24(4):419-425. doi: 10.1017/S1092852918000986. Epub 2018 Jun 26.
Results Reference
derived

Learn more about this trial

A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)

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