Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831

Alkermes

Status and phase

Completed

Phase 3

Conditions

Schizophreniform Disorder

Bipolar I Disorder

Schizophrenia

Treatments

Drug: ALKS 3831

Study type

Interventional

Funder types

Industry

Identifiers

NCT03201757

ALK3831-A308

Details and patient eligibility

About

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

Enrollment

523 patients

Sex

All

Ages

16 to 70 years old

Volunteers

No Healthy Volunteers

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