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COMPLETED Phase 3

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

NCT01895452 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • DRUG ALKS 9072, Low Dose
  • DRUG ALKS 9072, High Dose

Study Locations (20)

California

  • Alkermes Investigational Site — Garden Grove
  • Alkermes Investigational Site — Oakland
  • Alkermes Investigational Site — Oceanside
  • Alkermes Investigational Site — Orange

Illinois

  • Alkermes Investigational Site — Chicago
  • Alkermes Investigational Site — Chicago
  • Alkermes Investigational Site — Hoffman Estates

Other

  • Alkermes Investigational Site — Burgas
  • Alkermes Investigational Site — Novi Iskar
  • Alkermes Investigational Site — Pazardzhik

Arkansas

  • Alkermes Investigational Site — Little Rock
  • Alkermes Investigational Site — Little Rock

Florida

  • Alkermes Investigational Site — Fort Lauderdale
  • Alkermes Investigational Site — Leesburg

Texas

  • Alkermes Investigational Site — Dallas
  • Alkermes Investigational Site — Dallas

District of Columbia

  • Alkermes Investigational Site — Washington D.C.

Georgia

  • Alkermes Investigational Site — Atlanta

Trial Details

FieldValue
Enrollment Target 291 participants
Start Date 2013-07
Est. Completion 2016-06
Phase Phase 3

Sponsor

Alkermes

19 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01895452

The ClinicalTrials.gov registry entry for NCT01895452 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 291 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alkermes, which has 19 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions — of which ALKS 9072, Low Dose is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01895452 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Illinois, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01895452 about?

NCT01895452 is a clinical study titled "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.

What is the current status of trial NCT01895452?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 291 participants. The study started on 2013-07. Estimated completion is 2016-06.

What conditions does trial NCT01895452 study?

This clinical trial studies the following conditions: Schizophrenia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01895452?

The interventions under investigation include: ALKS 9072, Low Dose (DRUG), ALKS 9072, High Dose (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01895452?

This trial is sponsored by Alkermes, which has 19 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01895452 being conducted?

This trial has 20 study locations across Arkansas, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial