Long-term Safety and Efficacy of ABT-126 in Subjects With Schizophrenia: An Extension Study for Subjects Completing Study M10-855 (NCT01655680)

April 30, 2018 updated by: AbbVie

Long-Term Safety and Efficacy of ABT-126 in Subjects With Schizophrenia: A Double-Blind Extension Study for Subjects Completing Study M10-855

This is a study of ABT-126 in the treatment of cognitive impairment associated with schizophrenia (CIAS), a long-term extension study to study M10-855 (NCT01655680).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

268

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Chita, Russian Federation, 672090
        • Site Reference ID/Investigator# 117189
      • Ekaterinburg, Russian Federation, 620030
        • Site Reference ID/Investigator# 117178
      • Kazan, Russian Federation, 420061
        • Site Reference ID/Investigator# 117188
      • Lipetsk, Russian Federation, 399083
        • Site Reference ID/Investigator# 117175
      • Moscow, Russian Federation, 109559
        • Site Reference ID/Investigator# 117159
      • Moscow, Russian Federation, 115419
        • Site Reference ID/Investigator# 117183
      • Novosibirsk, Russian Federation, 630091
        • Site Reference ID/Investigator# 117182
      • Saint-Petersburg, Russian Federation, 195176
        • Site Reference ID/Investigator# 117195
      • Saratov, Russian Federation, 410028
        • Site Reference ID/Investigator# 117156
      • Saratov, Russian Federation, 410060
        • Site Reference ID/Investigator# 117177
      • St. Petersburg, Russian Federation, 190020
        • Site Reference ID/Investigator# 117157
      • St. Petersburg, Russian Federation, 190121
        • Site Reference ID/Investigator# 117185
      • St. Petersburg, Russian Federation, 191119
        • Site Reference ID/Investigator# 117192
      • St. Petersburg, Russian Federation, 191119
        • Site Reference ID/Investigator# 117193
      • St. Petersburg, Russian Federation, 192019
        • Site Reference ID/Investigator# 117176
      • St. Petersburg, Russian Federation, 197341
        • Site Reference ID/Investigator# 117186
      • Stavropol, Russian Federation, 357034
        • Site Reference ID/Investigator# 117180
      • Yaroslavl, Russian Federation, 150003
        • Site Reference ID/Investigator# 117181
      • Yekaterinburg, Russian Federation, 620028
        • Site Reference ID/Investigator# 117194
  • United Kingdom
      • Edinburgh, United Kingdom, EH10 5HF
        • Site Reference ID/Investigator# 117422
      • London, United Kingdom, SE5 8AF
        • Site Reference ID/Investigator# 117423
      • London, United Kingdom, W6 8RP
        • Site Reference ID/Investigator# 117425
      • Newcastle upon Tyne, United Kingdom, NE4 5PL
        • Site Reference ID/Investigator# 117424
      • Oxford, United Kingdom, OX3 7JX
        • Site Reference ID/Investigator# 117419
  • United States
    • California
      • Chino, California, United States, 91710
        • Site Reference ID/Investigator# 95398
      • Costa Mesa, California, United States, 92626
        • Site Reference ID/Investigator# 95381
      • Escondido, California, United States, 92025
        • Site Reference ID/Investigator# 95400
      • Garden Grove, California, United States, 92845
        • Site Reference ID/Investigator# 95406
      • National City, California, United States, 91950
        • Site Reference ID/Investigator# 95378
      • Norwalk, California, United States, 90650
        • Site Reference ID/Investigator# 95390
      • Oakland, California, United States, 94612
        • Site Reference ID/Investigator# 95386
      • Oceanside, California, United States, 92056
        • Site Reference ID/Investigator# 95391
      • Orange, California, United States, 92868
        • Site Reference ID/Investigator# 95380
      • Pico Rivera, California, United States, 90660
        • Site Reference ID/Investigator# 95395
      • Riverside, California, United States, 92506
        • Site Reference ID/Investigator# 95403
      • San Bernardino, California, United States, 92408
        • Site Reference ID/Investigator# 128356
      • San Diego, California, United States, 92102
        • Site Reference ID/Investigator# 95405
      • San Diego, California, United States, 92103
        • Site Reference ID/Investigator# 95397
      • San Gabriel, California, United States, 91776
        • Site Reference ID/Investigator# 95384
      • Santa Ana, California, United States, 92705
        • Site Reference ID/Investigator# 95385
      • Torrance, California, United States, 90502
        • Site Reference ID/Investigator# 95387
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Site Reference ID/Investigator# 95382
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Site Reference ID/Investigator# 95399
      • Marietta, Georgia, United States, 30060
        • Site Reference ID/Investigator# 95377
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Site Reference ID/Investigator# 120595
      • Hoffman Estates, Illinois, United States, 60169
        • Site Reference ID/Investigator# 129380
    • New York
      • Cedarhurst, New York, United States, 11516
        • Site Reference ID/Investigator# 95379
      • Rochester, New York, United States, 14623
        • Site Reference ID/Investigator# 95392
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19139
        • Site Reference ID/Investigator# 95388
    • Texas
      • DeSoto, Texas, United States, 75115
        • Site Reference ID/Investigator# 95402
      • Houston, Texas, United States, 77008
        • Site Reference ID/Investigator# 95393

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The subject was randomized into Study M10-855 and completed through Week 26 in that study.
  • The subject is receiving one or more antipsychotic medications.

Exclusion Criteria:

  • Additional history collected during participation in Study M10-855 provides evidence that, in the investigator's judgement, the subject does not have schizophrenia.
  • The subject experienced an adverse event or abnormal finding during physical examination, vital signs, laboratory profile, and/or electrocardiogram (ECG) measurements in Study M10-855 that indicates the subject is likely to become medically unstable during the current study.
  • The subject is currently taking or is expected to be prescribed any excluded medication without the approval of AbbVie medical monitor.
  • The subject is currently enrolled in, or plans to participate in, another interventional study during the course of this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABT-126 low dose
Drug: ABT-126
capsule(s)
Experimental: ABT-126 middle dose
Drug: ABT-126
capsule(s)
Experimental: ABT-126 high dose
Drug: ABT-126
capsule(s)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects with adverse events
Time Frame: up to 52 weeks
up to 52 weeks
Change in laboratory test results
Time Frame: from Day -1 to Week 52
from Day -1 to Week 52
Change in vital signs
Time Frame: from Day -1 to Week 52
from Day -1 to Week 52
Change in electrocardiogram (ECG) data
Time Frame: from Day -1 to Week 52
from Day -1 to Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Time Frame: from Day -1 to Week 52
rater based interview
from Day -1 to Week 52
Change in University of California San Diego Performance-Based Skills Assessment-2 (UPSA-2ER)
Time Frame: from Day -1 to Week 52
rater based interview to evaluate functioning
from Day -1 to Week 52
Change in the Positive and Negative Syndrome Scale (PANSS)
Time Frame: from Day -1 to Week 52
rater based interview to assess functioning
from Day -1 to Week 52
Change in the 16-item version of the Negative Symptom Assessment Scale (NSA-16)
Time Frame: from Day -1 to Week 52
rater based interview to assess symptom severity
from Day -1 to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

April 16, 2013

First Submitted That Met QC Criteria

April 16, 2013

First Posted (Estimate)

April 18, 2013

Study Record Updates

Last Update Posted (Actual)

May 2, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M13-765
  • 2012-005661-13 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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