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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
268

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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