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

Study Identifier
M13-765
CT.gov Identifier
NCT01834638
EudraCT Identifier
2012-005661-13
EUCTIS ID
Not available
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Study Details

Medical Condition
  • Schizophrenia
    • Study Drug
  • ABT-126
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    20 - 66 Years
    Inclusion and Exclusion Criteria
    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.

    Protocol Summary

    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 Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 95398
    Chino, California, United States, 91710
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 95381
    Costa Mesa, California, United States, 92626
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 95400
    Escondido, California, United States, 92025
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 95406
    Garden Grove, California, United States, 92845
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 95378
    National City, California, United States, 91950
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 95390
    Norwalk, California, United States, 90650
    Status
    Not applicable
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