Study to evaluate the long term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder.

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000918-36-BG

Enrollment

500

Registered

2017-05-09

Start date

2017-07-21

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia, schizophreniform disorder or bipolar I disorder MedDRA version: 20.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 21.1 Level: PT Classification code 10039647 Term: Schizophreniform disorder System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 20.0 Level: PT Classification code 10004939 Term: Bipolar I disorder System Organ Class: 10037175 - Psychiatric disorders

Interventions

Product Name: ALKS 3831 5mg/10mg Product Code: ALKS 3831 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: OLANZAPINE CAS Number: 132539-06-1 Current Sponsor code: OLZT Concentration unit:

ALKS 33 Other descriptive name: SAMIDORPHAN L-MALATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Product Name: ALKS 3831 10mg/10mg Product Code: ALKS 3831

ALKS 33 Other descriptive name: SAMIDORPHAN L-MALATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- INN or Proposed INN: OLANZAPINE CAS Number: 132539-06-1 Cur

ALKS 33 Other descriptive name: SAMIDORPHAN L-MALATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Product Name: ALKS 3831 20mg/10mg Product Code: ALKS 3831

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subject is willing and able to give informed consent/assent as per local requirements 2. Subject agrees to use an acceptable method of contraception during the study and until 30 days after any study drug administration during, unless surgically sterile or post-menopausal 3. Subject has the potential to benefit from the administration of ALKS 3831, in the opinion of the Investigator 4. Subject met eligibility criteria and completed the treatment period in one of the following antecedent studies within 7 days: ALK3831-A304, ALK3831-A306, or ALK3831-A307 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 494 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

Exclusion criteria: 1. Subject has any finding that in the view of the investigator or medical monitor would compromise the safety of the subject or affect his/her ability to fulfill the protocol visit schedule or visit requirements 2. Subject has a positive drug screen for drugs of abuse at study entry 3. Subject is currently pregnant. breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the long term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder.;Secondary Objective: None;Primary end point(s): Frequency of serious and non-serious adverse events;Timepoint(s) of evaluation of this end point: At monthly visits 1-25: 2,3,5,6,8,9,11,12,14,15,17,18,20,21,23,24 At monthly visits 26-50: 26,27,29,30,32,33,35,36,38,39,41,42,44,45,47,48 At quarterly visits 1-25: 4,7,10,13,16,19,22,25 At quarterly visits 26-50: 28,31,34,37,40,43,46	—

Measure

Time frame

Main Objective: To evaluate the long term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder.;Secondary Objective: None;Primary end point(s): Frequency of serious and non-serious adverse events;Timepoint(s) of evaluation of this end point: At monthly visits 1-25: 2,3,5,6,8,9,11,12,14,15,17,18,20,21,23,24 At monthly visits 26-50: 26,27,29,30,32,33,35,36,38,39,41,42,44,45,47,48 At quarterly visits 1-25: 4,7,10,13,16,19,22,25 At quarterly visits 26-50: 28,31,34,37,40,43,46

—

Secondary

Measure	Time frame
Secondary end point(s): Change from baseline in body weight and Change from baseline in Clinical Global Impression-Severity (CGI-S) scale;Timepoint(s) of evaluation of this end point: at each visit	—

Countries

Austria, Bulgaria, Ireland, Israel, Italy, Korea, Democratic People's Republic of, Poland, Romania, Russian Federation, Serbia, Spain, Ukraine, United Kingdom, United States

Contacts

Public ContactClinical Development

Alkermes Inc

christina.arevalo@alkermes.com++17816096381

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026