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NCT01895452 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Schizophrenia, sponsored by Alkermes.

Completed
Registry status
Phase 3
Development phase
291
Enrollment target
20
Study locations

NCT01895452 is a Phase 3 study of Schizophrenia that has completed, run by Alkermes. The registered enrollment target is 291 participants, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (33% higher). The trial reports 20 study locations across 10 states.

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The verdict

NCT01895452, a Phase 3 study of Schizophrenia, has completed, sponsored by Alkermes.

COMPLETED
Registry status
Phase 3
Development phase
291 participants
Enrollment target
20
Study locations

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

Schizophrenia

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

66 total trials

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What the Registry Record Tells You About NCT01895452

The ClinicalTrials.gov registry entry for NCT01895452 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 291 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (33% higher). The listed sponsor is Alkermes, which has 66 total studies on file at ClinicalTrials.gov.

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.

NCT01895452 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Illinois, Other.

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.

What interventions are being tested in trial NCT01895452?

The interventions under investigation include: ALKS 9072, Low Dose (DRUG), ALKS 9072, High Dose (DRUG).

Who is sponsoring clinical trial NCT01895452?

This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.