A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

A Phase 3 study testing ALKS 3831 in people with Schizophrenia, run by Alkermes, Inc. at 31 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Schizophrenia
What is being tested?: ALKS 3831
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 281 participants
Where: 31 sitesin 4 countries
Study dates: 20 Jan 2016to 29 Jun 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

31 sites in 4 countries.

Country

City, postcode or hospital

31 sites in 4 countries

United States14 sites

Alkermes Investigational Site
Chicago, Illinois, 60640
Alkermes Investigational Site
Culver City, California, 90230
Alkermes Investigational Site
Dallas, Texas, 75243
Alkermes Investigational Site
Dayton, Ohio, 45417
Alkermes Investigational Site
Garden Grove, California, 92845
Alkermes Investigational Site
Las Vegas, Nevada, 89102
Alkermes Investigational Site
Lemon Grove, California, 91945
Alkermes Investigational Site
Little Rock, Arkansas, 72211
Alkermes Investigational Site
Marlton, New Jersey, 08053
Alkermes Investigational Site
Miami, Florida, 33161
Alkermes Investigational Site
Orange, California, 92868
Alkermes Investigational Site
San Diego, California, 92103
Alkermes Investigational Site
Springdale, Arkansas, 72764
Alkermes Investigational Site
St Louis, Missouri, 63141

Other trials in United States

Bulgaria9 sites

Alkermes Investigational Site
Burgas
Alkermes Investigational Site
Kazanlak
Alkermes Investigational Site
Lovech
Alkermes Investigational Site
Novi Iskar
Alkermes Investigational Site
Plovdiv
Alkermes Investigational Site
Sofia
Alkermes Investigational Site
Tserova Koria
Alkermes Investigational Site
Veliko Tarnovo
Alkermes Investigational Site
Vratsa

Other trials in Bulgaria

Ukraine5 sites

Alkermes Investigational Site
Kharkiv
Alkermes Investigational Site
Kiev
Alkermes Investigational Site
Lviv
Alkermes Investigational Site
Stepanovka
Alkermes Investigational Site
Vinnytsia

Other trials in Ukraine

Serbia3 sites

Alkermes Investigational Site
Belgrade
Alkermes Investigational Site
Kragujevac
Alkermes Investigational Site
Novi Kneževac

Other trials in Serbia

About this study

Official title: A Phase 3, Multicenter Study to Assess the Long Term Safety and Tolerability of ALKS 3831 in Subjects With Schizophrenia

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

Conditions: Schizophrenia
Being tested: ALKS 3831
Keywords: Alkermes, ALKS 3831, Samidorphan, Schizophrenia, Safety
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ALKS 3831Drug
Tablets were administered for daily dosing

Study groups in NCT02669758
Study group	Role	What they receive
ALKS 3831	Experimental	Olanzapine + samidorphan; administered as a coated bilayer tablet. Receives: Drug: ALKS 3831

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events (AEs)
Measured: Up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jan 201629 Jun 2018

First posted1 Feb 2016 (estimated)
Study start20 Jan 2016
Primary completion29 Jun 2018
Study completion29 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 281 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02669758
Sponsor's protocol ID: ALK3831-A306
Status last verified: Jul 2019
First submitted: 28 Jan 2016
Last updated: 26 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

McIntyre RS, Matthews DM, Arevalo C, McDonnell D, Correll CU. The Efficacy of Olanzapine/Samidorphan on Negative Symptoms: A Post Hoc Analysis of 56-Week Treatment in Patients With Schizophrenia. J Clin Psychiatry. 2026 Mar 9;87(2):25m16170. doi: 10.4088/JCP.25m16170.
PubMed 41944743

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multicenter Study to Assess the Long Term Safety and Tolerability of ALKS 3831 in Subjects With Schizophrenia
ClinicalTrials.gov ID: NCT02669758
Acronym / sponsor ID: ALK3831-A306
Conditions: Schizophrenia
Keywords: Alkermes, ALKS 3831, Samidorphan, Schizophrenia, Safety
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 281 participants (actual)
Lead sponsor: Alkermes, Inc.Industry (pharma, biotech, devices)
Study start: 20 Jan 2016 (actual)
Primary completion: 29 Jun 2018 (actual)
Study completion: 29 Jun 2018 (actual)
First posted: 1 Feb 2016 (estimated)
Results: Posted 9 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ALKS 3831	Experimental	Drug: ALKS 3831Olanzapine + samidorphan; administered as a coated bilayer tablet.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ALKS 3831Tablets were administered for daily dosing	Drug	ALKS 3831

Primary outcome

Number of Participants With Adverse Events (AEs)
Time frame: Up to 52 weeks

Results and safety

Results posted to the registry on 9 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ALKS 3831	277	183

Primary outcome: Number of Participants With Adverse Events (AEs)

Time frame: Up to 52 weeks. Count of participants. Unit: Participants

Measure	ALKS 3831 n = 277
Value	136

Population analysed: Safety population includes all subjects who received at least one dose of study drug.

Adverse events

Time frame: Up to 52 weeks. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ALKS 3831	8 of 277 (2.9%)	102 of 277 (36.8%)	0 of 277

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41944743McIntyre RS, Matthews DM, Arevalo C, McDonnell D, Correll CU. The Efficacy of Olanzapine/Samidorphan on Negative Symptoms: A Post Hoc Analysis of 56-Week Treatment in Patients With Schizophrenia. J Clin Psychiatry. 2026 Mar 9;87(2):25m16170. doi: 10.4088/JCP.25m16170.

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alkermes Medical Director study director

Alkermes, Inc.

31 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ALKS 3831 in people with Schizophrenia, run by Alkermes, Inc. at 31 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Bulgaria, Ukraine, Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs) (time frame: Up to 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02669758, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.