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

NCT ID: NCT01834638

Last Updated: 2018-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-11-30

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).

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ABT-126 low dose

ABT-126 low dose

Group Type EXPERIMENTAL

ABT-126

Intervention Type DRUG

capsule(s)

ABT-126 middle dose

ABT-126 middle dose

Group Type EXPERIMENTAL

ABT-126

Intervention Type DRUG

capsule(s)

ABT-126 high dose

ABT-126 high dose

Group Type EXPERIMENTAL

ABT-126

Intervention Type DRUG

capsule(s)

Interventions

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ABT-126

capsule(s)

Intervention Type DRUG

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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George Haig, PharmD

Role: STUDY_DIRECTOR

AbbVie

Locations

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Site Reference ID/Investigator# 95398

Chino, California, United States

Site Status

Site Reference ID/Investigator# 95381

Costa Mesa, California, United States

Site Status

Site Reference ID/Investigator# 95400

Escondido, California, United States

Site Status

Site Reference ID/Investigator# 95406

Garden Grove, California, United States

Site Status

Site Reference ID/Investigator# 95378

National City, California, United States

Site Status

Site Reference ID/Investigator# 95390

Norwalk, California, United States

Site Status

Site Reference ID/Investigator# 95386

Oakland, California, United States

Site Status

Site Reference ID/Investigator# 95391

Oceanside, California, United States

Site Status

Site Reference ID/Investigator# 95380

Orange, California, United States

Site Status

Site Reference ID/Investigator# 95395

Pico Rivera, California, United States

Site Status

Site Reference ID/Investigator# 95403

Riverside, California, United States

Site Status

Site Reference ID/Investigator# 128356

San Bernardino, California, United States

Site Status

Site Reference ID/Investigator# 95405

San Diego, California, United States

Site Status

Site Reference ID/Investigator# 95397

San Diego, California, United States

Site Status

Site Reference ID/Investigator# 95384

San Gabriel, California, United States

Site Status

Site Reference ID/Investigator# 95385

Santa Ana, California, United States

Site Status

Site Reference ID/Investigator# 95387

Torrance, California, United States

Site Status

Site Reference ID/Investigator# 95382

New Haven, Connecticut, United States

Site Status

Site Reference ID/Investigator# 95399

Atlanta, Georgia, United States

Site Status

Site Reference ID/Investigator# 95377

Marietta, Georgia, United States

Site Status

Site Reference ID/Investigator# 120595

Chicago, Illinois, United States

Site Status

Site Reference ID/Investigator# 129380

Hoffman Estates, Illinois, United States

Site Status

Site Reference ID/Investigator# 95379

Cedarhurst, New York, United States

Site Status

Site Reference ID/Investigator# 95392

Rochester, New York, United States

Site Status

Site Reference ID/Investigator# 95388

Philadelphia, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 95402

DeSoto, Texas, United States

Site Status

Site Reference ID/Investigator# 95393

Houston, Texas, United States

Site Status

Site Reference ID/Investigator# 117189

Chita, , Russia

Site Status

Site Reference ID/Investigator# 117188

Kazan', , Russia

Site Status

Site Reference ID/Investigator# 117175

Lipetsk, , Russia

Site Status

Site Reference ID/Investigator# 117159

Moscow, , Russia

Site Status

Site Reference ID/Investigator# 117183

Moscow, , Russia

Site Status

Site Reference ID/Investigator# 117182

Novosibirsk, , Russia

Site Status

Site Reference ID/Investigator# 117157

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 117185

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 117192

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 117193

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 117176

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 117195

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 117186

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 117156

Saratov, , Russia

Site Status

Site Reference ID/Investigator# 117177

Saratov, , Russia

Site Status

Site Reference ID/Investigator# 117180

Stavropol, , Russia

Site Status

Site Reference ID/Investigator# 117181

Yaroslavl, , Russia

Site Status

Site Reference ID/Investigator# 117194

Yekaterinburg, , Russia

Site Status

Site Reference ID/Investigator# 117178

Yekaterinburg, , Russia

Site Status

Site Reference ID/Investigator# 117422

Edinburgh, , United Kingdom

Site Status

Site Reference ID/Investigator# 117423

London, , United Kingdom

Site Status

Site Reference ID/Investigator# 117425

London, , United Kingdom

Site Status

Site Reference ID/Investigator# 117424

Newcastle upon Tyne, , United Kingdom

Site Status

Site Reference ID/Investigator# 117419

Oxford, , United Kingdom

Site Status

Countries

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United States Russia United Kingdom

References

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Haig G, Wang D, Othman AA, Zhao J. The alpha7 Nicotinic Agonist ABT-126 in the Treatment of Cognitive Impairment Associated with Schizophrenia in Nonsmokers: Results from a Randomized Controlled Phase 2b Study. Neuropsychopharmacology. 2016 Nov;41(12):2893-2902. doi: 10.1038/npp.2016.101. Epub 2016 Jun 20.

Reference Type RESULT
PMID: 27319970 (View on PubMed)

Other Identifiers

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2012-005661-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M13-765

Identifier Type: -

Identifier Source: org_study_id

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