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
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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TERMINATED
PHASE2
268 participants
INTERVENTIONAL
2013-03-31
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ABT-126 low dose
ABT-126 low dose
ABT-126
capsule(s)
ABT-126 middle dose
ABT-126 middle dose
ABT-126
capsule(s)
ABT-126 high dose
ABT-126 high dose
ABT-126
capsule(s)
Interventions
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ABT-126
capsule(s)
Eligibility Criteria
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Inclusion Criteria
* The subject is receiving one or more antipsychotic medications.
Exclusion Criteria
* 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.
20 Years
66 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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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 Reference ID/Investigator# 95381
Costa Mesa, California, United States
Site Reference ID/Investigator# 95400
Escondido, California, United States
Site Reference ID/Investigator# 95406
Garden Grove, California, United States
Site Reference ID/Investigator# 95378
National City, California, United States
Site Reference ID/Investigator# 95390
Norwalk, California, United States
Site Reference ID/Investigator# 95386
Oakland, California, United States
Site Reference ID/Investigator# 95391
Oceanside, California, United States
Site Reference ID/Investigator# 95380
Orange, California, United States
Site Reference ID/Investigator# 95395
Pico Rivera, California, United States
Site Reference ID/Investigator# 95403
Riverside, California, United States
Site Reference ID/Investigator# 128356
San Bernardino, California, United States
Site Reference ID/Investigator# 95405
San Diego, California, United States
Site Reference ID/Investigator# 95397
San Diego, California, United States
Site Reference ID/Investigator# 95384
San Gabriel, California, United States
Site Reference ID/Investigator# 95385
Santa Ana, California, United States
Site Reference ID/Investigator# 95387
Torrance, California, United States
Site Reference ID/Investigator# 95382
New Haven, Connecticut, United States
Site Reference ID/Investigator# 95399
Atlanta, Georgia, United States
Site Reference ID/Investigator# 95377
Marietta, Georgia, United States
Site Reference ID/Investigator# 120595
Chicago, Illinois, United States
Site Reference ID/Investigator# 129380
Hoffman Estates, Illinois, United States
Site Reference ID/Investigator# 95379
Cedarhurst, New York, United States
Site Reference ID/Investigator# 95392
Rochester, New York, United States
Site Reference ID/Investigator# 95388
Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 95402
DeSoto, Texas, United States
Site Reference ID/Investigator# 95393
Houston, Texas, United States
Site Reference ID/Investigator# 117189
Chita, , Russia
Site Reference ID/Investigator# 117188
Kazan', , Russia
Site Reference ID/Investigator# 117175
Lipetsk, , Russia
Site Reference ID/Investigator# 117159
Moscow, , Russia
Site Reference ID/Investigator# 117183
Moscow, , Russia
Site Reference ID/Investigator# 117182
Novosibirsk, , Russia
Site Reference ID/Investigator# 117157
Saint Petersburg, , Russia
Site Reference ID/Investigator# 117185
Saint Petersburg, , Russia
Site Reference ID/Investigator# 117192
Saint Petersburg, , Russia
Site Reference ID/Investigator# 117193
Saint Petersburg, , Russia
Site Reference ID/Investigator# 117176
Saint Petersburg, , Russia
Site Reference ID/Investigator# 117195
Saint Petersburg, , Russia
Site Reference ID/Investigator# 117186
Saint Petersburg, , Russia
Site Reference ID/Investigator# 117156
Saratov, , Russia
Site Reference ID/Investigator# 117177
Saratov, , Russia
Site Reference ID/Investigator# 117180
Stavropol, , Russia
Site Reference ID/Investigator# 117181
Yaroslavl, , Russia
Site Reference ID/Investigator# 117194
Yekaterinburg, , Russia
Site Reference ID/Investigator# 117178
Yekaterinburg, , Russia
Site Reference ID/Investigator# 117422
Edinburgh, , United Kingdom
Site Reference ID/Investigator# 117423
London, , United Kingdom
Site Reference ID/Investigator# 117425
London, , United Kingdom
Site Reference ID/Investigator# 117424
Newcastle upon Tyne, , United Kingdom
Site Reference ID/Investigator# 117419
Oxford, , United Kingdom
Countries
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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.
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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