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 Inc0 sites500 target enrollmentJune 22, 2017

Overview

No summary available.

Registry

who.int

Start Date

June 22, 2017

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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 30 days prior to the study, during the study, and until 30 days after any study drug administration, 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 has completed the treatment period in one of the following antecedent studies within 7 days: ALK3831\-A304, ALK3831\-A306, or ALK3831\-A307
•5\. 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 500
•F.1\.3 Elderly (\>\=65 years) no

•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
•4\. Subject is employed by Alkermes, the Investigator or study site (permanent, temporary contract worker, or designee responsible for the conduct of the study) or is immediate family1 of an Alkermes, clinical research organization, or study site employee
•5\. Additional criteria may apply