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

Primary Purpose

Schizophrenia

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ABT-126
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia

Eligibility Criteria

20 Years - 66 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Site Reference ID/Investigator# 95398
  • Site Reference ID/Investigator# 95381
  • Site Reference ID/Investigator# 95400
  • Site Reference ID/Investigator# 95406
  • Site Reference ID/Investigator# 95378
  • Site Reference ID/Investigator# 95390
  • Site Reference ID/Investigator# 95386
  • Site Reference ID/Investigator# 95391
  • Site Reference ID/Investigator# 95380
  • Site Reference ID/Investigator# 95395
  • Site Reference ID/Investigator# 95403
  • Site Reference ID/Investigator# 128356
  • Site Reference ID/Investigator# 95405
  • Site Reference ID/Investigator# 95397
  • Site Reference ID/Investigator# 95384
  • Site Reference ID/Investigator# 95385
  • Site Reference ID/Investigator# 95387
  • Site Reference ID/Investigator# 95382
  • Site Reference ID/Investigator# 95399
  • Site Reference ID/Investigator# 95377
  • Site Reference ID/Investigator# 120595
  • Site Reference ID/Investigator# 129380
  • Site Reference ID/Investigator# 95379
  • Site Reference ID/Investigator# 95392
  • Site Reference ID/Investigator# 95388
  • Site Reference ID/Investigator# 95402
  • Site Reference ID/Investigator# 95393
  • Site Reference ID/Investigator# 117189
  • Site Reference ID/Investigator# 117178
  • Site Reference ID/Investigator# 117188
  • Site Reference ID/Investigator# 117175
  • Site Reference ID/Investigator# 117159
  • Site Reference ID/Investigator# 117183
  • Site Reference ID/Investigator# 117182
  • Site Reference ID/Investigator# 117195
  • Site Reference ID/Investigator# 117156
  • Site Reference ID/Investigator# 117177
  • Site Reference ID/Investigator# 117157
  • Site Reference ID/Investigator# 117185
  • Site Reference ID/Investigator# 117192
  • Site Reference ID/Investigator# 117193
  • Site Reference ID/Investigator# 117176
  • Site Reference ID/Investigator# 117186
  • Site Reference ID/Investigator# 117180
  • Site Reference ID/Investigator# 117181
  • Site Reference ID/Investigator# 117194
  • Site Reference ID/Investigator# 117422
  • Site Reference ID/Investigator# 117423
  • Site Reference ID/Investigator# 117425
  • Site Reference ID/Investigator# 117424
  • Site Reference ID/Investigator# 117419

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

ABT-126 low dose

ABT-126 middle dose

ABT-126 high dose

Arm Description

ABT-126 low dose

ABT-126 middle dose

ABT-126 high dose

Outcomes

Primary Outcome Measures

Percentage of subjects with adverse events
Change in laboratory test results
Change in vital signs
Change in electrocardiogram (ECG) data

Secondary Outcome Measures

Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
rater based interview
Change in University of California San Diego Performance-Based Skills Assessment-2 (UPSA-2ER)
rater based interview to evaluate functioning
Change in the Positive and Negative Syndrome Scale (PANSS)
rater based interview to assess functioning
Change in the 16-item version of the Negative Symptom Assessment Scale (NSA-16)
rater based interview to assess symptom severity

Full Information

First Posted
April 16, 2013
Last Updated
April 30, 2018
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT01834638
Brief Title
Long-term Safety and Efficacy of ABT-126 in Subjects With Schizophrenia: An Extension Study for Subjects Completing Study M10-855 (NCT01655680)
Official Title
Long-Term Safety and Efficacy of ABT-126 in Subjects With Schizophrenia: A Double-Blind Extension Study for Subjects Completing Study M10-855
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Terminated
Why Stopped
Study endpoint in preceding base study M10-855 not met.
Study Start Date
March 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
268 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABT-126 low dose
Arm Type
Experimental
Arm Description
ABT-126 low dose
Arm Title
ABT-126 middle dose
Arm Type
Experimental
Arm Description
ABT-126 middle dose
Arm Title
ABT-126 high dose
Arm Type
Experimental
Arm Description
ABT-126 high dose
Intervention Type
Drug
Intervention Name(s)
ABT-126
Intervention Description
capsule(s)
Primary Outcome Measure Information:
Title
Percentage of subjects with adverse events
Time Frame
up to 52 weeks
Title
Change in laboratory test results
Time Frame
from Day -1 to Week 52
Title
Change in vital signs
Time Frame
from Day -1 to Week 52
Title
Change in electrocardiogram (ECG) data
Time Frame
from Day -1 to Week 52
Secondary Outcome Measure Information:
Title
Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Description
rater based interview
Time Frame
from Day -1 to Week 52
Title
Change in University of California San Diego Performance-Based Skills Assessment-2 (UPSA-2ER)
Description
rater based interview to evaluate functioning
Time Frame
from Day -1 to Week 52
Title
Change in the Positive and Negative Syndrome Scale (PANSS)
Description
rater based interview to assess functioning
Time Frame
from Day -1 to Week 52
Title
Change in the 16-item version of the Negative Symptom Assessment Scale (NSA-16)
Description
rater based interview to assess symptom severity
Time Frame
from Day -1 to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Haig, PharmD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 95398
City
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
Site Reference ID/Investigator# 95381
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Site Reference ID/Investigator# 95400
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Site Reference ID/Investigator# 95406
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Site Reference ID/Investigator# 95378
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Site Reference ID/Investigator# 95390
City
Norwalk
State/Province
California
ZIP/Postal Code
90650
Country
United States
Facility Name
Site Reference ID/Investigator# 95386
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
Site Reference ID/Investigator# 95391
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Site Reference ID/Investigator# 95380
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Site Reference ID/Investigator# 95395
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
Site Reference ID/Investigator# 95403
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Site Reference ID/Investigator# 128356
City
San Bernardino
State/Province
California
ZIP/Postal Code
92408
Country
United States
Facility Name
Site Reference ID/Investigator# 95405
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
Site Reference ID/Investigator# 95397
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Site Reference ID/Investigator# 95384
City
San Gabriel
State/Province
California
ZIP/Postal Code
91776
Country
United States
Facility Name
Site Reference ID/Investigator# 95385
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Site Reference ID/Investigator# 95387
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Site Reference ID/Investigator# 95382
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Site Reference ID/Investigator# 95399
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Site Reference ID/Investigator# 95377
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Site Reference ID/Investigator# 120595
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Site Reference ID/Investigator# 129380
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Site Reference ID/Investigator# 95379
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Site Reference ID/Investigator# 95392
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Site Reference ID/Investigator# 95388
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Site Reference ID/Investigator# 95402
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Site Reference ID/Investigator# 95393
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Site Reference ID/Investigator# 117189
City
Chita
ZIP/Postal Code
672090
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 117178
City
Ekaterinburg
ZIP/Postal Code
620030
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 117188
City
Kazan
ZIP/Postal Code
420061
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 117175
City
Lipetsk
ZIP/Postal Code
399083
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 117159
City
Moscow
ZIP/Postal Code
109559
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 117183
City
Moscow
ZIP/Postal Code
115419
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 117182
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 117195
City
Saint-Petersburg
ZIP/Postal Code
195176
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 117156
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 117177
City
Saratov
ZIP/Postal Code
410060
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 117157
City
St. Petersburg
ZIP/Postal Code
190020
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 117185
City
St. Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 117192
City
St. Petersburg
ZIP/Postal Code
191119
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 117193
City
St. Petersburg
ZIP/Postal Code
191119
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 117176
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 117186
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 117180
City
Stavropol
ZIP/Postal Code
357034
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 117181
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 117194
City
Yekaterinburg
ZIP/Postal Code
620028
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 117422
City
Edinburgh
ZIP/Postal Code
EH10 5HF
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 117423
City
London
ZIP/Postal Code
SE5 8AF
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 117425
City
London
ZIP/Postal Code
W6 8RP
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 117424
City
Newcastle upon Tyne
ZIP/Postal Code
NE4 5PL
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 117419
City
Oxford
ZIP/Postal Code
OX3 7JX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27319970
Citation
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.
Results Reference
result

Learn more about this trial

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

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