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

Study Overview
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Brief Summary
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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).

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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: ABT-126


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with adverse events |  | up to 52 weeks | 
| Change in laboratory test results |  | from Day -1 to Week 52 | 
| Change in vital signs |  | from Day -1 to Week 52 | 
| Change in electrocardiogram (ECG) data |  | 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) | rater based interview | from Day -1 to Week 52 | 
| Change in University of California San Diego Performance-Based Skills Assessment-2 (UPSA-2ER) | rater based interview to evaluate functioning | from Day -1 to Week 52 | 
| Change in the Positive and Negative Syndrome Scale (PANSS) | 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) | rater based interview to assess symptom severity | from Day -1 to Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia