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

AbbVie

Status and phase: Terminated; Phase 2

Conditions: Schizophrenia

Treatments: Drug: ABT-126

Study type: Interventional

Funder types: Industry

Identifiers

NCT01834638

2012-005661-13 (EudraCT Number)

M13-765

Details and patient eligibility

About

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).

Enrollment: 268 patients

Sex: All

Ages: 20 to 66 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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268 participants in 3 patient groups

ABT-126 low dose

Experimental group

Description:

ABT-126 low dose

Treatment:

Drug: ABT-126

ABT-126 middle dose

Experimental group

Description:

ABT-126 middle dose

Treatment:

Drug: ABT-126

ABT-126 high dose

Experimental group

Description:

ABT-126 high dose

Treatment:

Drug: ABT-126