Study to evaluate the long term safety and tolerability of ALKS 3831 in adult patients who have with Schizophrenia

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003880-13-SK

Enrollment

390

Registered

2016-02-25

Start date

2016-04-25

Completion date

Unknown

Last updated

2017-05-29

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

Conditions

Schizophrenia MedDRA version: 18.1 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders

Interventions

Product Name: ALKS 3831 Product Code: ALKS 3831 Pharmaceutical Form: Tablet INN or Proposed INN: OLANZAPINE CAS Number: 132539-06-1 Current Sponsor code: OLZT Concentration unit: mg milligram(s) Conce

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 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 370 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to evaluate the long term safety and tolerability of ALKS 3831 in subjects with schizophrenia.;Secondary Objective: Not applicable;Primary end point(s): Incidence of Adverse Events;Timepoint(s) of evaluation of this end point: At all visits	—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Bulgaria, Hungary, Serbia, Slovakia, Ukraine, United States

Contacts

Public ContactClinical Development

Alkermes Inc

adam.simmons@alkermes.com++1718609-6288

Outcome results

None listed

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