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

Alkermes, Inc.1 site in 1 country524 target enrollmentJune 15, 2017

ConditionsSchizophrenia Schizophreniform Disorder Bipolar I Disorder

InterventionsALKS 3831

DrugsALKS 3831

Overview

Phase: Phase 3
Intervention: ALKS 3831
Conditions: Schizophrenia
Sponsor: Alkermes, Inc.
Enrollment: 524
Locations: 1
Primary Endpoint: Incidence of Adverse Events
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

June 15, 2017

End Date

September 6, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Alkermes, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Arms & Interventions

ALKS 3831

Coated bilayer tablet

Intervention: ALKS 3831

Outcomes

Primary Outcomes

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