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An Extension of 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 Dose
ALKS 9072, High Dose
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 Schizophrenia

Eligibility Criteria

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

Inclusion Criteria:

  • Completed the treatment period of Study ALK9072-003EXT
  • Continues to require chronic treatment with an antipsychotic medication
  • Continues to reside in a stable living situation
  • Continues to have an identified reliable informant

Exclusion Criteria:

  • Abnormal clinical laboratory value, vital sign, or electrocardiogram (ECG) finding during participation in Study ALK9072-003EXT that was clinically relevant and related to study drug
  • Missed more than 1 scheduled study visit during participation in the preceding Study ALK9072-003EXT
  • 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, or has pending legal action which may impact compliance with study participation or procedures

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
  • Roshchino township
  • Roshchino township
  • 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
  • Roshchino township

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ALKS 9072, Low Dose

ALKS 9072, High Dose

Arm Description

Outcomes

Primary Outcome Measures

Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)
This measure includes all incidences, including those that occurred >5%.

Secondary Outcome Measures

Change in Baseline of Positive and Negative Syndrome Scale (PANSS) Total Score Over Time
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); maximum scores (worst outcome) equals 210 (total scale). Change is calculated between the baseline visit and the subject's last visit in the treatment period.
Mean Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Over Time
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. Change is calculated between the baseline visit and the subject's last visit in the treatment period.

Full Information

First Posted
July 5, 2013
Last Updated
July 25, 2017
Sponsor
Alkermes, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01895452
Brief Title
An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
Official Title
A Phase 3, Multicenter Extension of Study ALK9072-003EXT 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
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (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 is an extension of a previous study (ALK9072-003EXT). The purpose of this study is to continue to evaluate the long-term safety and durability of effect of ALKS 9072 in subjects with stable schizophrenia, and to allow subjects who are doing well on ALKS 9072 to continue treatment.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
ALKS 9072, Low Dose
Arm Type
Experimental
Arm Title
ALKS 9072, High Dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ALKS 9072, Low Dose
Intervention Description
Intramuscular injection, given monthly
Intervention Type
Drug
Intervention Name(s)
ALKS 9072, High Dose
Intervention Description
Intramuscular injection, given monthly
Primary Outcome Measure Information:
Title
Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)
Description
This measure includes all incidences, including those that occurred >5%.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Change in Baseline of Positive and Negative Syndrome Scale (PANSS) Total Score Over Time
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); maximum scores (worst outcome) equals 210 (total scale). Change is calculated between the baseline visit and the subject's last visit in the treatment period.
Time Frame
Up to 12 months
Title
Mean Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Over Time
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. Change is calculated between the baseline visit and the subject's last visit in the treatment period.
Time Frame
Up to 12 months

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: Completed the treatment period of Study ALK9072-003EXT Continues to require chronic treatment with an antipsychotic medication Continues to reside in a stable living situation Continues to have an identified reliable informant Exclusion Criteria: Abnormal clinical laboratory value, vital sign, or electrocardiogram (ECG) finding during participation in Study ALK9072-003EXT that was clinically relevant and related to study drug Missed more than 1 scheduled study visit during participation in the preceding Study ALK9072-003EXT 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, or has pending legal action which may impact compliance with study participation or procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Risinger, MD
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
Garden Grove
State/Province
California
ZIP/Postal Code
92845
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
Washington, D.C.
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
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Alkermes Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
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
Novi Iskar
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Pazardzhik
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Plovdiv
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Sofia
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
Jeollanam-do
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 Lampur
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
Bucharest
Country
Romania
Facility Name
Alkermes Investigational Site
City
Oradea
Country
Romania
Facility Name
Alkermes Investigational Site
City
Targu Mures
Country
Romania
Facility Name
Alkermes Investigational Site
City
Roshchino
State/Province
Vyborgskiy
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
Rostov-on-Don
Country
Russian Federation
Facility Name
Roshchino township
City
Samara
Country
Russian Federation
Facility Name
Roshchino township
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
Yaroslavl
Country
Russian Federation
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
Kherson
Country
Ukraine
Facility Name
Alkermes Investigational Site
City
Kyiv
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
Ternopil
Country
Ukraine
Facility Name
Roshchino township
City
Vinnytsia
ZIP/Postal Code
61068
Country
Ukraine

12. IPD Sharing Statement

Citations:
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

Learn more about this trial

An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)

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