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Completed

NCT Number: NCT01895452

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alkermes Investigational Site, Burgas, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALKS 9072, Low Dose

Drug

Intramuscular injection, given monthly

ALKS 9072, High Dose

Drug

Intramuscular injection, given monthly

Primary outcomes

  1. Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to 12 months

    This measure includes all incidences, including those that occurred >5%.

Secondary outcomes

  1. Change in Baseline of Positive and Negative Syndrome Scale (PANSS) Total Score Over Time

    Time frame: 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.

  2. Mean Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Over Time

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

A Phase 3, Multicenter Extension of Study ALK9072-003EXT to Assess the Long-term Safety and Durability of Effect of ALKS 9072 in Subjects With Stable Schizophrenia

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 10, 2013
Registry last updated
Aug 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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