An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)

Alkermes

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Treatments

Drug: ALKS 9072, Low Dose

Drug: ALKS 9072, High Dose

Study type

Interventional

Funder types

Industry

Identifiers

NCT01895452

ALK9072-003EXT2

Details and patient eligibility

About

This is an extension of a previous study (ALK9072-003EXT). The purpose of this study is to continue to evaluate the long-term safety and durability of effect of ALKS 9072 in subjects with stable schizophrenia, and to allow subjects who are doing well on ALKS 9072 to continue treatment.

Enrollment

291 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Completed the treatment period of Study ALK9072-003EXT
Continues to require chronic treatment with an antipsychotic medication
Continues to reside in a stable living situation
Continues to have an identified reliable informant

Exclusion criteria

Abnormal clinical laboratory value, vital sign, or electrocardiogram (ECG) finding during participation in Study ALK9072-003EXT that was clinically relevant and related to study drug
Missed more than 1 scheduled study visit during participation in the preceding Study ALK9072-003EXT
Has a significant or unstable medical condition that would preclude safe completion of the current study
Subject is pregnant or breastfeeding
Subject expects to be incarcerated, or has pending legal action which may impact compliance with study participation or procedures