NCT02873208

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
266

participants targeted

Target at P25-P50 for phase_3 schizophrenia

Timeline
Completed

Started Aug 2016

Typical duration for phase_3 schizophrenia

Geographic Reach
2 countries

45 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

August 7, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2019

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

July 21, 2021

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

3.2 years

First QC Date

August 16, 2016

Results QC Date

June 22, 2021

Last Update Submit

July 20, 2021

Conditions

Schizophrenia

Keywords

AlkermesALKS 3831SamidorphanSchizophreniaSafety

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With Adverse Events

    Overall summary of treatment emergent adverse events during the treatment period

    Up to 52 weeks

Study Arms (1)

ALKS 3831

EXPERIMENTAL

Oral tablet, daily dosing

Drug: ALKS 3831

Interventions

ALKS 3831DRUG

Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan

ALKS 3831

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Agrees to use an acceptable method of contraception for the duration of the study
  • Subject has completed the 24-week treatment period in the antecedent study, ALK3831-A303, within 7 days
  • Additional criteria may apply

You may not qualify if:

  • Subject is currently taking medications that are contraindicated with olanzapine use or exhibit drug-interaction potential with olanzapine
  • 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 (45)

Alkermes Investigational Site

Little Rock, Arkansas, 72211, United States

Location

Alkermes Investigational Site

Springdale, Arkansas, 72764, United States

Location

Alkermes Investigational Site

Anaheim, California, 92805, United States

Location

Alkermes Investigational Site

Cerritos, California, 90703, 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

Glendale, California, 91206, United States

Location

Alkermes Investigational Site

Lemon Grove, California, 91945, United States

Location

Alkermes Investigational Site

Long Beach, California, 90822, United States

Location

Alkermes Investigational Site

Oakland, California, 94612, United States

Location

Alkermes Investigational Site

Oceanside, California, 92056, United States

Location

Alkermes Investigational Site

Orange, California, 92868, United States

Location

Alkermes Investigational Site

Pico Rivera, California, 90660, United States

Location

Alkermes Investigational Site

Redlands, California, 92374, United States

Location

Alkermes Investigational Site

San Diego, California, 92103, United States

Location

Alkermes Investigational Site

San Diego, California, 92123, United States

Location

Alkermes Investigational Site

Temecula, California, 92591, United States

Location

Alkermes Investigational Site

Torrance, California, 90502, United States

Location

Alkermes Investigational Site

Hollywood, Florida, 33024, United States

Location

Alkermes Investigational Site

Lauderhill, Florida, 33319, United States

Location

Alkermes Investigational Site

North Miami, Florida, 33161, United States

Location

Alkermes Investigational Site

Atlanta, Georgia, 30329, United States

Location

Alkermes Investigational Site

Augusta, Georgia, 30912, United States

Location

Alkermes Investigational Site

Decatur, Georgia, 30030, United States

Location

Alkermes Investigational Site

Chicago, Illinois, 60640, United States

Location

Alkermes Investigational Site

Grand Rapids, Michigan, 49503, United States

Location

Alkermes Investigational Site

Flowood, Mississippi, 39232, United States

Location

Alkermes Investigational Site

Creve Coeur, Missouri, 63141, United States

Location

Alkermes Investigational Site

St Louis, Missouri, 63128, United States

Location

Alkermes Investigational Site

Las Vegas, Nevada, 89102, United States

Location

Alkermes Investigational Site

Berlin, New Jersey, 08009, United States

Location

Alkermes Investigational Site

Marlton, New Jersey, 08053, United States

Location

Alkermes Investigational Site

Brooklyn, New York, 11235, United States

Location

Alkermes Investigational Site

Jamaica, New York, 11432, United States

Location

Alkermes Investigational Site

Rochester, New York, 14615, United States

Location

Alkermes Investigational Site

Canton, Ohio, 44718, United States

Location

Alkermes Investigational Site

Dayton, Ohio, 45417, United States

Location

Alkermes Investigational Site

Austin, Texas, 78754, United States

Location

Alkermes Investigational Site

Austin, Texas, 78759, United States

Location

Alkermes Investigational Site

Dallas, Texas, 75243, United States

Location

Alkermes Investigational Site

DeSoto, Texas, 75115, United States

Location

Alkermes Investigational Site

Houston, Texas, 77030, United States

Location

Alkermes Investigational Site

Bellevue, Washington, 98007, United States

Location

Alkermes Investigational Site

San Juan, 00918, Puerto Rico

Location

Alkermes Investigational Site

San Juan, 00926, Puerto Rico

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Results Point of Contact

Title
Director, Corporate and R&D Communications
Organization
Alkermes
Gretchen.Murphy@alkermes.com
781-609-7000

Study Officials

  • Alkermes Medical Director

    Alkermes, Inc.

    PRINCIPAL INVESTIGATOR

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

August 16, 2016

First Posted

August 19, 2016

Study Start

August 7, 2016

Primary Completion

October 17, 2019

Study Completion

October 17, 2019

Last Updated

July 21, 2021

Results First Posted

July 21, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

PR(2)US(43)