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

NCT01834638 | Terminated Phase 2

• 2 other identifiers: M13-7652012-005661-13
• Study Type: interventional
• Target: 268
• Locations: 3 countries
• Sites: 51

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).

Conditions

Schizophrenia

Keywords

schizophrenia

Outcome Measures

Primary Outcomes (4)

• Percentage of subjects with adverse events

  up to 52 weeks

• Change in laboratory test results

  from Day -1 to Week 52

• Change in vital signs

  from Day -1 to Week 52

• Change in electrocardiogram (ECG) data

  from Day -1 to Week 52

Secondary Outcomes (4)

• Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)

  from Day -1 to Week 52

• Change in University of California San Diego Performance-Based Skills Assessment-2 (UPSA-2ER)

  from Day -1 to Week 52

• Change in the Positive and Negative Syndrome Scale (PANSS)

  from Day -1 to Week 52

• Change in the 16-item version of the Negative Symptom Assessment Scale (NSA-16)

  from Day -1 to Week 52

Study Arms (3)

ABT-126 low dose

EXPERIMENTAL

ABT-126 low dose

Drug: ABT-126

ABT-126 middle dose

EXPERIMENTAL

ABT-126 middle dose

Drug: ABT-126

ABT-126 high dose

EXPERIMENTAL

ABT-126 high dose

Drug: ABT-126

Interventions

ABT-126 DRUG

capsule(s)

ABT-126 high dose; ABT-126 low dose; ABT-126 middle dose

Eligibility Criteria

• Age: 20 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (51)

Site Reference ID/Investigator# 95398

Chino, California, 91710, United States

Location

Site Reference ID/Investigator# 95381

Costa Mesa, California, 92626, United States

Location

Site Reference ID/Investigator# 95400

Escondido, California, 92025, United States

Location

Site Reference ID/Investigator# 95406

Garden Grove, California, 92845, United States

Location

Site Reference ID/Investigator# 95378

National City, California, 91950, United States

Location

Site Reference ID/Investigator# 95390

Norwalk, California, 90650, United States

Location

Site Reference ID/Investigator# 95386

Oakland, California, 94612, United States

Location

Site Reference ID/Investigator# 95391

Oceanside, California, 92056, United States

Location

Site Reference ID/Investigator# 95380

Orange, California, 92868, United States

Location

Site Reference ID/Investigator# 95395

Pico Rivera, California, 90660, United States

Location

Site Reference ID/Investigator# 95403

Riverside, California, 92506, United States

Location

Site Reference ID/Investigator# 128356

San Bernardino, California, 92408, United States

Location

Site Reference ID/Investigator# 95405

San Diego, California, 92102, United States

Location

Site Reference ID/Investigator# 95397

San Diego, California, 92103, United States

Location

Site Reference ID/Investigator# 95384

San Gabriel, California, 91776, United States

Location

Site Reference ID/Investigator# 95385

Santa Ana, California, 92705, United States

Location

Site Reference ID/Investigator# 95387

Torrance, California, 90502, United States

Location

Site Reference ID/Investigator# 95382

New Haven, Connecticut, 06519, United States

Location

Site Reference ID/Investigator# 95399

Atlanta, Georgia, 30308, United States

Location

Site Reference ID/Investigator# 95377

Marietta, Georgia, 30060, United States

Location

Site Reference ID/Investigator# 120595

Chicago, Illinois, 60640, United States

Location

Site Reference ID/Investigator# 129380

Hoffman Estates, Illinois, 60169, United States

Location

Site Reference ID/Investigator# 95379

Cedarhurst, New York, 11516, United States

Location

Site Reference ID/Investigator# 95392

Rochester, New York, 14623, United States

Location

Site Reference ID/Investigator# 95388

Philadelphia, Pennsylvania, 19139, United States

Location

Site Reference ID/Investigator# 95402

DeSoto, Texas, 75115, United States

Location

Site Reference ID/Investigator# 95393

Houston, Texas, 77008, United States

Location

Site Reference ID/Investigator# 117189

Chita, 672090, Russia

Location

Site Reference ID/Investigator# 117188

Kazan', 420061, Russia

Location

Site Reference ID/Investigator# 117175

Lipetsk, 399083, Russia

Location

Site Reference ID/Investigator# 117159

Moscow, 109559, Russia

Location

Site Reference ID/Investigator# 117183

Moscow, 115419, Russia

Location

Site Reference ID/Investigator# 117182

Novosibirsk, 630091, Russia

Location

Site Reference ID/Investigator# 117157

Saint Petersburg, 190020, Russia

Location

Site Reference ID/Investigator# 117185

Saint Petersburg, 190121, Russia

Location

Site Reference ID/Investigator# 117192

Saint Petersburg, 191119, Russia

Location

Site Reference ID/Investigator# 117193

Saint Petersburg, 191119, Russia

Location

Site Reference ID/Investigator# 117176

Saint Petersburg, 192019, Russia

Location

Site Reference ID/Investigator# 117195

Saint Petersburg, 195176, Russia

Location

Site Reference ID/Investigator# 117186

Saint Petersburg, 197341, Russia

Location

Site Reference ID/Investigator# 117156

Saratov, 410028, Russia

Location

Site Reference ID/Investigator# 117177

Saratov, 410060, Russia

Location

Site Reference ID/Investigator# 117180

Stavropol, 357034, Russia

Location

Site Reference ID/Investigator# 117181

Yaroslavl, 150003, Russia

Location

Site Reference ID/Investigator# 117194

Yekaterinburg, 620028, Russia

Location

Site Reference ID/Investigator# 117178

Yekaterinburg, 620030, Russia

Location

Site Reference ID/Investigator# 117422

Edinburgh, EH10 5HF, United Kingdom

Location

Site Reference ID/Investigator# 117423

London, SE5 8AF, United Kingdom

Location

Site Reference ID/Investigator# 117425

London, W6 8RP, United Kingdom

Location

Site Reference ID/Investigator# 117424

Newcastle upon Tyne, NE4 5PL, United Kingdom

Location

Site Reference ID/Investigator# 117419

Oxford, OX3 7JX, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 27319970 RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

ABT-126

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• George Haig, PharmD

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: April 18, 2013
• Study Start: March 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: May 2, 2018

Record last verified: 2014-10

Locations

GB (5); RU (19); US (27)