SchizophreniaPhase 3NCT03201757

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

A Phase 3 study testing ALKS 3831 in people with Schizophrenia and Schizophreniform Disorder, run by Alkermes, Inc. at 85 sites in 13 countries.

Completed

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

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 16 to 70 years
Conditions the study is for: Schizophrenia, Schizophreniform Disorder, Bipolar I Disorder
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: 523 participants
Where: 85 sitesin 13 countries
Study dates: 15 Jun 2017to 6 Sep 2023
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 16 to 70 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

85 sites in 13 countries.

Country

City, postcode or hospital

85 sites in 13 countries

United States49 sites

Alkermes Investigational Site
Anaheim, California, 92805
Alkermes Investigational Site
Atlanta, Georgia, 30303
Alkermes Investigational Site
Atlanta, Georgia, 30329
Alkermes Investigational Site
Atlanta, Georgia, 30331
Alkermes Investigational Site
Augusta, Georgia, 30912
Alkermes Investigational Site
Austin, Texas, 78759
Alkermes Investigational Site
Bellevue, Washington, 98007
Alkermes Investigational Site
Berlin, New Jersey, 08009
Alkermes Investigational Site
Brooklyn, New York, 11235
Alkermes Investigational Site
Canton, Ohio, 44718
Alkermes Investigational Site
Cerritos, California, 90703
Alkermes Investigational Site
Chicago, Illinois, 60611
Alkermes Investigational Site
Chicago, Illinois, 60640
Alkermes Investigational Site
Cincinnati, Ohio, 45219
Alkermes Investigational Site
Culver City, California, 90230
Alkermes Investigational Site
Dayton, Ohio, 45417
Alkermes Investigational Site
Decatur, Georgia, 30030
Alkermes Investigational Site
DeSoto, Texas, 75115
Alkermes Investigational Site
Eugene, Oregon, 97401
Alkermes Investigational Site
Flowood, Mississippi, 39232
Alkermes Investigational Site
Fort Worth, Texas, 76104
Alkermes Investigational Site
Garden Grove, California, 92845
Alkermes Investigational Site
Glendale, California, 91206
Alkermes Investigational Site
Grand Rapids, Michigan, 49503
Alkermes Investigational Site
Houston, Texas, 77030
Alkermes Investigational Site
Kansas City, Missouri, 64108
Alkermes Investigational Site
Las Vegas, Nevada, 89102
Alkermes Investigational Site
Lauderhill, Florida, 33319
Alkermes Investigational Site
Little Rock, Arkansas, 72211
Alkermes Investigational Site
Long Beach, California, 90822
Alkermes Investigational Site
Marlton, New Jersey, 08053
Alkermes Investigational Site
North Miami, Florida, 33161
Alkermes Investigational Site
Oakland, California, 94607
Alkermes Investigational Site
Oceanside, California, 92056
Alkermes Investigational Site
Orange, California, 92868
Alkermes Investigational Site
Palo Alto, California, 94305
Alkermes Investigational Site
Pico Rivera, California, 90660
Alkermes Investigational Site
Redlands, California, 92374
Alkermes Investigational Site
Richardson, Texas, 75080
Alkermes Investigational Site
Rochester, New York, 14615
Alkermes Investigational Site
Rogers, Arkansas, 72758
Alkermes Investigational Site
San Diego, California, 92013
Alkermes Investigational Site
St Louis, Missouri, 63110
Alkermes Investigational Site
St Louis, Missouri, 63118
Alkermes Investigational Site
St Louis, Missouri, 63128
Alkermes Investigational Site
St Louis, Missouri, 63141
Alkermes Investigational Site
Temecula, California, 92591
Alkermes Investigational Site
Torrance, California, 90502
Alkermes Investigational Site
Winfield, Illinois, 60190

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Bulgaria8 sites

Alkermes Investigational Site
Burgas
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

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Russia8 sites

Alkermes Investigational Site
Arkhangelsk
Alkermes Investigational Site
Moscow
Alkermes Investigational Site
Roshchino
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Rostov-on-Don
Alkermes Investigational Site
Saint Petersburg
Alkermes Investigational Site
Samara
Alkermes Investigational Site
Saratov
Alkermes Investigational Site
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Ukraine7 sites

Alkermes Investigational Site
Kharkiv
Alkermes Investigational Site
Kherson
Alkermes Investigational Site
Kyiv
Alkermes Investigational Site
Lviv
Alkermes Investigational Site
Poltava
Alkermes Investigational Site
Smila
Alkermes Investigational Site
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Serbia3 sites

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

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Israel2 sites

Alkermes Investigational Site
Jerusalem
Alkermes Investigational Site
Ramat Gan

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Italy2 sites

Alkermes Investigational Site
Brescia
Alkermes Investigational Site
Naples

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Austria1 site

Alkermes Investigational Site
Vienna

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Ireland1 site

Alkermes Investigational Site
Galway

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Poland1 site

Alkermes Investigational Site
Poznan

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Puerto Rico1 site

Alkermes Investigational Site
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South Korea1 site

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United Kingdom1 site

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About this study

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

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

Conditions: Schizophrenia, Schizophreniform Disorder, Bipolar I Disorder
Being tested: ALKS 3831
Keywords: Alkermes, ALKS 3831, Olanzapine, Samidorphan, Schizophrenia, Schizophreniform, Bipolar I
Medical subject headings: Schizophrenia, Psychotic Disorders

What participants receive

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

ALKS 3831Drug
Olanzapine + samidorphan, daily oral dosing

Study groups in NCT03201757
Study group	Role	What they receive
ALKS 3831	Experimental	Coated bilayer tablet Receives: Drug: ALKS 3831

What is being measured

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

Incidence of Adverse Events
Measured: Up to 48 months
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis; 1 being normal, not ill at all and 7 being among the severally ill patients
Measured: Up to 48 months

Timeline

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

15 Jun 20176 Sep 2023

First posted28 Jun 2017
Study start15 Jun 2017
Primary completion6 Sep 2023
Study completion6 Sep 2023

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
Model description: Open-label
Masking: None (open label)
Enrolment: 523 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03201757
Sponsor's protocol ID: ALK3831-A308
Status last verified: Aug 2024
First submitted: 15 Jun 2017
Last updated: 26 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Ballon JS, Kahn RS, Arevalo C, Dunbar M, McDonnell D, Correll CU. Long-Term Safety, Tolerability, and Durability of Treatment Effect of Olanzapine and Samidorphan: Results of a 4-Year Open-Label Study. J Clin Psychiatry. 2024 Dec 4;86(1):24m15511. doi: 10.4088/JCP.24m15511.
PubMed 39630083

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

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03201757
Acronym / sponsor ID: ALK3831-A308
Conditions: Schizophrenia, Schizophreniform Disorder, Bipolar I Disorder
Keywords: Alkermes, ALKS 3831, Olanzapine, Samidorphan, Schizophrenia, Schizophreniform, Bipolar I
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 523 participants (actual)
Lead sponsor: Alkermes, Inc.Industry (pharma, biotech, devices)
Study start: 15 Jun 2017 (actual)
Primary completion: 6 Sep 2023 (actual)
Study completion: 6 Sep 2023 (actual)
First posted: 28 Jun 2017 (actual)
Results: Posted 26 Sep 2024

Clinical summary

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

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

Study design

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

Arm	Type	Receives
ALKS 3831	Experimental	Drug: ALKS 3831Coated bilayer tablet

Who may qualify

Ages: 16 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (4 listed)

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

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 3831Olanzapine + samidorphan, daily oral dosing	Drug	ALKS 3831

Primary outcome

Incidence of Adverse Events
Time frame: Up to 48 months
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale
Time frame: Up to 48 months
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis; 1 being normal, not ill at all and 7 being among the severally ill patients

Results and safety

Results posted to the registry on 26 Sep 2024, 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	523	188

Primary outcome: Incidence of Adverse Events

Time frame: Up to 48 months. Count of participants. Unit: Participants

Measure	ALKS 3831 n = 523
Value	314

Population analysed: All enrolled participants who received at least 1 dose of study drug

Primary outcome: Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale

Time frame: Up to 48 months. Mean (Standard Deviation). Unit: units on a scale

Measure	ALKS 3831 n = 523
Value	-.24 (.651)

Adverse events

Time frame: Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ALKS 3831	35 of 523 (6.7%)	314 of 523 (60%)	1 of 523

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39630083Ballon JS, Kahn RS, Arevalo C, Dunbar M, McDonnell D, Correll CU. Long-Term Safety, Tolerability, and Durability of Treatment Effect of Olanzapine and Samidorphan: Results of a 4-Year Open-Label Study. J Clin Psychiatry. 2024 Dec 4;86(1):24m15511. doi: 10.4088/JCP.24m15511.
Individual participant dataSharing planned: No

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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.

85 sites in 13 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 and Schizophreniform Disorder, run by Alkermes, Inc. at 85 sites in 13 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 5 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 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States, Bulgaria, Russia, Ukraine, Serbia and 8 more countries. 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 26 Sep 2024). 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?

Incidence of Adverse Events (time frame: Up to 48 months). The study lists 2 primary outcomes in all. 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 NCT03201757, 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 Sep 2024.