Status:
TERMINATED
Long-term Safety and Efficacy of ABT-126 in Subjects With Schizophrenia: An Extension Study for Subjects Completing Study M10-855 (NCT01655680)
Lead Sponsor:
AbbVie
Conditions:
Schizophrenia
Eligibility:
All Genders
20-66 years
Phase:
PHASE2
Brief 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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT01834638
Start Date
March 1 2013
End Date
November 1 2014
Last Update
May 2 2018
Active Locations (51)
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1
Site Reference ID/Investigator# 95398
Chino, California, United States, 91710
2
Site Reference ID/Investigator# 95381
Costa Mesa, California, United States, 92626
3
Site Reference ID/Investigator# 95400
Escondido, California, United States, 92025
4
Site Reference ID/Investigator# 95406
Garden Grove, California, United States, 92845