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

NCT01895452 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 291

Last updated 2017-08-25

Study results available
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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.

Conditions

Interventions

DRUG

ALKS 9072, Low Dose

Intramuscular injection, given monthly

DRUG

ALKS 9072, High Dose

Intramuscular injection, given monthly

Sponsors & Collaborators

  • Alkermes, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Risinger, MD · Alkermes, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States
  • Bulgaria
  • Malaysia
  • Philippines
  • Romania
  • Russia
  • South Korea
  • Ukraine

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01895452 on ClinicalTrials.gov