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

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: ALKS 9072, High Dose; Drug: ALKS 9072, Low Dose

• Registration Number: NCT01895452
• Lead Sponsor: Alkermes, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-05
• Study First Submitted QC: 2013-07-09
• Study First Posted: 2013-07-10
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Results First Submitted: 2017-06-22
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-25
• Last Update Submitted: 2017-07-25
• Results First Posted: 2017-08-25
• Last Update Posted: 2017-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 291

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALKS 9072, High Dose	ALKS 9072, High Dose	-
ALKS 9072, Low Dose	ALKS 9072, Low Dose	-

Primary Outcome Measures

Name	Time	Method
Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)	Up to 12 months	This measure includes all incidences, including those that occurred \>5%.

Secondary Outcome Measures

Name	Time	Method
Change in Baseline of Positive and Negative Syndrome Scale (PANSS) Total Score Over Time	Up to 12 months	This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale); maximum scores (worst outcome) equals 210 (total scale). Change is calculated between the baseline visit and the subject's last visit in the treatment period.
Mean Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Over Time	Up to 12 months	The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients". Results indicate a change in CGI-S score from baseline to Day 365 based on the observed data. Change is calculated between the baseline visit and the subject's last visit in the treatment period.

Trial Locations

Locations (2)

Roshchino township; 🇺🇦 Vinnytsia, Ukraine

Alkermes Investigational Site; 🇺🇦 Ternopil, Ukraine