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Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831

Primary Purpose

Schizophrenia, Schizophreniform Disorder, Bipolar I Disorder

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ALKS 3831
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, ALKS 3831, Olanzapine, Samidorphan, Schizophrenia, Schizophreniform, Bipolar I

Eligibility Criteria

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

Inclusion Criteria:

  • Willing and able to give informed consent/assent as per local requirements
  • Agrees to use an acceptable method of contraception during the study, and for 30 days after any study drug administration, unless surgically sterile or post-menopausal
  • Has the potential to benefit from the administration of ALKS 3831, in the opinion of the investigator
  • Subject met the eligibility criteria of the antecedent study at the time of enrollment in the antecedent study and completed the treatment period in one of the following antecedent studies within 7 days: ALK3831-A304, ALK3831-A306, or ALK3831-A307
  • Additional criteria may apply

Exclusion Criteria:

  • Has any finding that, in the view of the investigator or medical monitor, would compromise the safety of the subject or affect their ability to fulfill the protocol visit schedule or visit requirements
  • Has a positive drug screen for drugs of abuse at study entry
  • Currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration
  • Additional 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
  • Alkermes Investigational Site
  • Alkermes Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ALKS 3831

Arm Description

Coated bilayer tablet

Outcomes

Primary Outcome Measures

Safety will be measured by frequency of serious and non-serious adverse events

Secondary Outcome Measures

Full Information

First Posted
June 15, 2017
Last Updated
September 13, 2023
Sponsor
Alkermes, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03201757
Brief Title
Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831
Official Title
A Phase 3 Study to Assess the Long Term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 in Subjects With Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the long-term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizophreniform Disorder, Bipolar I Disorder
Keywords
Alkermes, ALKS 3831, Olanzapine, Samidorphan, Schizophrenia, Schizophreniform, Bipolar I

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Open-label
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ALKS 3831
Arm Type
Experimental
Arm Description
Coated bilayer tablet
Intervention Type
Drug
Intervention Name(s)
ALKS 3831
Intervention Description
Olanzapine + samidorphan, daily oral dosing
Primary Outcome Measure Information:
Title
Safety will be measured by frequency of serious and non-serious adverse events
Time Frame
Up to 48 months
Other Pre-specified Outcome Measures:
Title
Change from baseline in body weight
Time Frame
Up to 48 months
Title
Change from baseline in Clinical Global Impression-Severity (CGI-S) scale
Time Frame
Up to 48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Willing and able to give informed consent/assent as per local requirements Agrees to use an acceptable method of contraception during the study, and for 30 days after any study drug administration, unless surgically sterile or post-menopausal Has the potential to benefit from the administration of ALKS 3831, in the opinion of the investigator Subject met the eligibility criteria of the antecedent study at the time of enrollment in the antecedent study and completed the treatment period in one of the following antecedent studies within 7 days: ALK3831-A304, ALK3831-A306, or ALK3831-A307 Additional criteria may apply Exclusion Criteria: Has any finding that, in the view of the investigator or medical monitor, would compromise the safety of the subject or affect their ability to fulfill the protocol visit schedule or visit requirements Has a positive drug screen for drugs of abuse at study entry Currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration Additional 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
72211
Country
United States
Facility Name
Alkermes Investigational Site
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Alkermes Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
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
Culver City
State/Province
California
ZIP/Postal Code
90230
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
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Alkermes Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Alkermes Investigational Site
City
Oakland
State/Province
California
ZIP/Postal Code
94607
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
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Alkermes Investigational Site
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
Alkermes Investigational Site
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Alkermes Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92013
Country
United States
Facility Name
Alkermes Investigational Site
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Alkermes Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Alkermes Investigational Site
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Alkermes Investigational Site
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Alkermes Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Alkermes Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Alkermes Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Alkermes Investigational Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Alkermes Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
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
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
Alkermes Investigational Site
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Alkermes Investigational Site
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Alkermes Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Alkermes Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
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
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Alkermes Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Alkermes Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Alkermes Investigational Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Alkermes Investigational Site
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Alkermes Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Alkermes Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14615
Country
United States
Facility Name
Alkermes Investigational Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Alkermes Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Alkermes Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Alkermes Investigational Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Alkermes Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Alkermes Investigational Site
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Alkermes Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Alkermes Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Alkermes Investigational Site
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Alkermes Investigational Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Alkermes Investigational Site
City
Vienna
Country
Austria
Facility Name
Alkermes Investigational Site
City
Burgas
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Lovech
Country
Bulgaria
Facility Name
Alkermes Investigational Site
City
Novi Iskar
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
Tserova Koria
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
Galway
Country
Ireland
Facility Name
Alkermes Investigational Site
City
Jerusalem
Country
Israel
Facility Name
Alkermes Investigational Site
City
Ramat Gan
Country
Israel
Facility Name
Alkermes Investigational Site
City
Brescia
Country
Italy
Facility Name
Alkermes Investigational Site
City
Napoli
Country
Italy
Facility Name
Alkermes Investigational Site
City
Busan
Country
Korea, Republic of
Facility Name
Alkermes Investigational Site
City
Poznań
Country
Poland
Facility Name
Alkermes Investigational Site
City
San Juan
Country
Puerto Rico
Facility Name
Alkermes Investigational Site
City
Arkhangel'sk
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Roshchino
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Rostov-on-Don
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Saint Petersburg
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Samara
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Saratow
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Tonnel'nyy
Country
Russian Federation
Facility Name
Alkermes Investigational Site
City
Belgrade
Country
Serbia
Facility Name
Alkermes Investigational Site
City
Belgrad
Country
Serbia
Facility Name
Alkermes Investigational Site
City
Kragujevac
Country
Serbia
Facility Name
Alkermes Investigational Site
City
Novi Kneževac
Country
Serbia
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
Smila
Country
Ukraine
Facility Name
Alkermes Investigational Site
City
Vinnytsia
Country
Ukraine
Facility Name
Alkermes Investigational Site
City
Headington
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831

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