NCT02669758

Brief Summary

The primary objective of this study is to evaluate the long term safety and tolerability of ALKS 3831 in subjects with schizophrenia.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
281

participants targeted

Target at P50-P75 for phase_3 schizophrenia

Timeline
Completed

Started Jan 2016

Typical duration for phase_3 schizophrenia

Geographic Reach
4 countries

31 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2018

Completed
1 year until next milestone

Results Posted

Study results publicly available

July 9, 2019

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

2.4 years

First QC Date

January 28, 2016

Results QC Date

June 18, 2019

Last Update Submit

July 15, 2019

Conditions

Schizophrenia

Keywords

AlkermesALKS 3831SamidorphanSchizophreniaSafety

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Events (AEs)

    Up to 52 weeks

Study Arms (1)

ALKS 3831

EXPERIMENTAL

Olanzapine + samidorphan; administered as a coated bilayer tablet.

Drug: ALKS 3831

Interventions

ALKS 3831DRUG

Tablets were administered for daily dosing

ALKS 3831

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has completed the 4-week treatment period (all visits up to and including end of treatment visit) in the antecedent study ALK3831-A305 within 7 days.
  • Agrees to use an acceptable method of contraception for the duration of the study.
  • Additional criteria may apply.

You may not qualify if:

  • Subject is currently taking medications that are contraindicated with olanzapine use.
  • Subject has a positive test for drugs of abuse at study entry.
  • Subject is pregnant, planning to become pregnant, or breastfeeding during the study.
  • Additional criteria may apply.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

Alkermes Investigational Site

Little Rock, Arkansas, 72211, United States

Location

Alkermes Investigational Site

Springdale, Arkansas, 72764, United States

Location

Alkermes Investigational Site

Culver City, California, 90230, United States

Location

Alkermes Investigational Site

Garden Grove, California, 92845, United States

Location

Alkermes Investigational Site

Lemon Grove, California, 91945, United States

Location

Alkermes Investigational Site

Orange, California, 92868, United States

Location

Alkermes Investigational Site

San Diego, California, 92103, United States

Location

Alkermes Investigational Site

Miami, Florida, 33161, United States

Location

Alkermes Investigational Site

Chicago, Illinois, 60640, United States

Location

Alkermes Investigational Site

St Louis, Missouri, 63141, United States

Location

Alkermes Investigational Site

Las Vegas, Nevada, 89102, United States

Location

Alkermes Investigational Site

Marlton, New Jersey, 08053, United States

Location

Alkermes Investigational Site

Dayton, Ohio, 45417, United States

Location

Alkermes Investigational Site

Dallas, Texas, 75243, United States

Location

Alkermes Investigational Site

Burgas, Bulgaria

Location

Alkermes Investigational Site

Kazanlak, Bulgaria

Location

Alkermes Investigational Site

Lovech, Bulgaria

Location

Alkermes Investigational Site

Novi Iskar, Bulgaria

Location

Alkermes Investigational Site

Plovdiv, Bulgaria

Location

Alkermes Investigational Site

Sofia, Bulgaria

Location

Alkermes Investigational Site

Tserova Koria, Bulgaria

Location

Alkermes Investigational Site

Veliko Tarnovo, Bulgaria

Location

Alkermes Investigational Site

Vratsa, Bulgaria

Location

Alkermes Investigational Site

Belgrade, Serbia

Location

Alkermes Investigational Site

Kragujevac, Serbia

Location

Alkermes Investigational Site

Novi Kneževac, Serbia

Location

Alkermes Investigational Site

Kharkiv, Ukraine

Location

Alkermes Investigational Site

Kiev, Ukraine

Location

Alkermes Investigational Site

Lviv, Ukraine

Location

Alkermes Investigational Site

Stepanovka, Ukraine

Location

Alkermes Investigational Site

Vinnytsia, Ukraine

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Results Point of Contact

Title
Eva Stroynowski
Organization
Alkermes
Eva.Stroynowski@alkermes.com
781-609-7000

Study Officials

  • Alkermes Medical Director

    Alkermes, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2016

First Posted

February 1, 2016

Study Start

January 20, 2016

Primary Completion

June 29, 2018

Study Completion

June 29, 2018

Last Updated

July 26, 2019

Results First Posted

July 9, 2019

Record last verified: 2019-07

Locations

BU(9)US(14)SE(3)UA(5)