A Phase 3, 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 45 sites in 2 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 55 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: 266 participants
Where: 45 sitesin 2 countries
Study dates: 7 Aug 2016to 17 Oct 2019
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 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

45 sites in 2 countries.

Country

City, postcode or hospital

45 sites in 2 countries

United States43 sites

Alkermes Investigational Site
Anaheim, California, 92805
Alkermes Investigational Site
Atlanta, Georgia, 30329
Alkermes Investigational Site
Augusta, Georgia, 30912
Alkermes Investigational Site
Austin, Texas, 78754
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, 60640
Alkermes Investigational Site
Creve Coeur, Missouri, 63141
Alkermes Investigational Site
Culver City, California, 90230
Alkermes Investigational Site
Dallas, Texas, 75243
Alkermes Investigational Site
Dayton, Ohio, 45417
Alkermes Investigational Site
Decatur, Georgia, 30030
Alkermes Investigational Site
DeSoto, Texas, 75115
Alkermes Investigational Site
Flowood, Mississippi, 39232
Alkermes Investigational Site
Garden Grove, California, 92845
Alkermes Investigational Site
Glendale, California, 91206
Alkermes Investigational Site
Grand Rapids, Michigan, 49503
Alkermes Investigational Site
Hollywood, Florida, 33024
Alkermes Investigational Site
Houston, Texas, 77030
Alkermes Investigational Site
Jamaica, New York, 11432
Alkermes Investigational Site
Las Vegas, Nevada, 89102
Alkermes Investigational Site
Lauderhill, Florida, 33319
Alkermes Investigational Site
Lemon Grove, California, 91945
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, 94612
Alkermes Investigational Site
Oceanside, California, 92056
Alkermes Investigational Site
Orange, California, 92868
Alkermes Investigational Site
Pico Rivera, California, 90660
Alkermes Investigational Site
Redlands, California, 92374
Alkermes Investigational Site
Rochester, New York, 14615
Alkermes Investigational Site
San Diego, California, 92103
Alkermes Investigational Site
San Diego, California, 92123
Alkermes Investigational Site
Springdale, Arkansas, 72764
Alkermes Investigational Site
St Louis, Missouri, 63128
Alkermes Investigational Site
Temecula, California, 92591
Alkermes Investigational Site
Torrance, California, 90502

Other trials in United States

Puerto Rico2 sites

Alkermes Investigational Site
San Juan, 00918
Alkermes Investigational Site
San Juan, 00926

Other trials in Puerto Rico

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

Study groups in NCT02873208
Study group	Role	What they receive
ALKS 3831	Experimental	Oral tablet, daily dosing Receives: Drug: ALKS 3831

What is being measured

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

Number of Subjects With Adverse Events
Overall summary of treatment emergent adverse events during the treatment period
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.

7 Aug 201617 Oct 2019

First posted19 Aug 2016 (estimated)
Study start7 Aug 2016
Primary completion17 Oct 2019
Study completion17 Oct 2019

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.
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: 266 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02873208
Sponsor's protocol ID: ALK3831-A304
Status last verified: Jul 2021
First submitted: 16 Aug 2016
Last updated: 21 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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 1
A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia
Schizophrenia
Recruiting
A Relation Between Craving Induction and Treatment Response in Deep Transcranial Magnetic Stimulation (dTMS) for Reducing Antipsychotic-induced Weight Gain in Schizophrenia
Schizophrenia, Antipsychotic Induced Weight Gain
Recruiting
Impact of Cerebellar TMS on Brain and Cognitive Functions in Schizophrenia: a Pilot Study
Schizophrenia, Cerebellar Function
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tACS for Working Memory in Schizophrenia
Schizophrenia, Working Memory
Recruiting
Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium: Study 3
Schizophrenia / Schizoaffective Disorder, SCHIZOPHRENIA 1 (Disorder)

All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2021. 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: NCT02873208
Acronym / sponsor ID: ALK3831-A304
Conditions: Schizophrenia
Keywords: Alkermes, ALKS 3831, Samidorphan, Schizophrenia, Safety
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 266 participants (actual)
Lead sponsor: Alkermes, Inc.Industry (pharma, biotech, devices)
Study start: 7 Aug 2016 (actual)
Primary completion: 17 Oct 2019 (actual)
Study completion: 17 Oct 2019 (actual)
First posted: 19 Aug 2016 (estimated)
Results: Posted 21 Jul 2021

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 3831Oral tablet, daily dosing

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

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 3831Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan	Drug	ALKS 3831

Primary outcome

Number of Subjects With Adverse Events
Time frame: Up to 52 weeks
Overall summary of treatment emergent adverse events during the treatment period

Results and safety

Results posted to the registry on 21 Jul 2021, 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	265	167

Primary outcome: Number of Subjects With Adverse Events

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

Measure	ALKS 3831 n = 265
Any Treatment Emergent Adverse Event (TEAE)	161
Mild Treatment Emergent Adverse Event (TEAE)	93
Moderate Treatment- Emergent Adverse Event (TEAE)	61
Severe Treatment- Emergent Adverse Event (TEAE)	7
Treatment- Emergent Adverse Event (TEAE)-Not Related	82
Treatment- Emergent Adverse Event (TEAE)-Related	79
Adverse Event Leading to Treatment Discontinuation	15
Any Serious Adverse Event (SAE)	5

Population analysed: Safety population was defined as all subjects who received at least one dose of the study drug

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
ALKS 3831	5 of 265 (1.9%)	103 of 265 (38.9%)	0 of 265

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Schizophrenia

RecruitingPhase 1
A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia
Schizophrenia
Recruiting
A Relation Between Craving Induction and Treatment Response in Deep Transcranial Magnetic Stimulation (dTMS) for Reducing Antipsychotic-induced Weight Gain in Schizophrenia
Schizophrenia, Antipsychotic Induced Weight Gain
Recruiting
Impact of Cerebellar TMS on Brain and Cognitive Functions in Schizophrenia: a Pilot Study
Schizophrenia, Cerebellar Function
Recruiting
tACS for Working Memory in Schizophrenia
Schizophrenia, Working Memory
Recruiting
Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium: Study 3
Schizophrenia / Schizoaffective Disorder, SCHIZOPHRENIA 1 (Disorder)

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 principal investigator

Alkermes, Inc.

45 sites in 2 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 45 sites in 2 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 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Puerto Rico. 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 21 Jul 2021). 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 Subjects With Adverse Events (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 NCT02873208.

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 21 Jul 2021.