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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005661-13-GB

Enrollment

430

Registered

2013-03-22

Start date

2013-09-25

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive deficits in schizophrenia MedDRA version: 17.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders

Interventions

Product Name: ABT-126 25 mg Product Code: ABT-126 25 mg Pharmaceutical Form: Capsule, hard INN or Proposed INN: N/A CAS Number: N/A Current Sponsor code: ABT-126 Other descriptive name: ABT-126 Concen

Eligibility

Sex/Gender

All

Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 430 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this study is to obtain long-term safety, efficacy and health outcomes data in patients with schizophrenia.;Secondary Objective: Not applicable.;Primary end point(s): Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB);Timepoint(s) of evaluation of this end point: From Day -1 to Week 52	—

Secondary

Measure	Time frame
Secondary end point(s): Change in University of California San Diego Performance-Based Skills Assessment-2 (UPSA-2ER);Timepoint(s) of evaluation of this end point: From Week 24 of M10-855 to Week 52	—

Countries

Romania, Russian Federation, United Kingdom, United States

Contacts

Public ContactEU Clinical Trials Helpdesk

AbbVie Ltd.

eu-clinical-trials@abbvie.com+44 1628 77 4695

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026