Clinical trial NCT01834638: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: schizophrenia
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2013-04-18
Enrollment: 268
Sex: ALL
Minimum age (years): 20
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Percentage of subjects with adverse events
timeFrame: up to 52 weeks
measure: Change in laboratory test results
timeFrame: from Day -1 to Week 52
measure: Change in vital signs
timeFrame: from Day -1 to Week 52
measure: Change in electrocardiogram (ECG) data
timeFrame: from Day -1 to Week 52
Secondary outcomes:
measure: Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: from Day -1 to Week 52
measure: Change in University of California San Diego Performance-Based Skills Assessment-2 (UPSA-2ER)
timeFrame: from Day -1 to Week 52
measure: Change in the Positive and Negative Syndrome Scale (PANSS)
timeFrame: from Day -1 to Week 52
measure: Change in the 16-item version of the Negative Symptom Assessment Scale (NSA-16)
timeFrame: from Day -1 to Week 52
Other outcomes:
Locations:
city: Chino
country: United States
facility: Site Reference ID/Investigator# 95398
state: California
city: Costa Mesa
country: United States
facility: Site Reference ID/Investigator# 95381
state: California
city: Escondido
country: United States
facility: Site Reference ID/Investigator# 95400
state: California
city: Garden Grove
country: United States
facility: Site Reference ID/Investigator# 95406
state: California
city: National City
country: United States
facility: Site Reference ID/Investigator# 95378
state: California
city: Norwalk
country: United States
facility: Site Reference ID/Investigator# 95390
state: California
city: Oakland
country: United States
facility: Site Reference ID/Investigator# 95386
state: California
city: Oceanside
country: United States
facility: Site Reference ID/Investigator# 95391
state: California
city: Orange
country: United States
facility: Site Reference ID/Investigator# 95380
state: California
city: Pico Rivera
country: United States
facility: Site Reference ID/Investigator# 95395
state: California
city: Riverside
country: United States
facility: Site Reference ID/Investigator# 95403
state: California
city: San Bernardino
country: United States
facility: Site Reference ID/Investigator# 128356
state: California
city: San Diego
country: United States
facility: Site Reference ID/Investigator# 95405
state: California
city: San Diego
country: United States
facility: Site Reference ID/Investigator# 95397
state: California
city: San Gabriel
country: United States
facility: Site Reference ID/Investigator# 95384
state: California
city: Santa Ana
country: United States
facility: Site Reference ID/Investigator# 95385
state: California
city: Torrance
country: United States
facility: Site Reference ID/Investigator# 95387
state: California
city: New Haven
country: United States
facility: Site Reference ID/Investigator# 95382
state: Connecticut
city: Atlanta
country: United States
facility: Site Reference ID/Investigator# 95399
state: Georgia
city: Marietta
country: United States
facility: Site Reference ID/Investigator# 95377
state: Georgia
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 120595
state: Illinois
city: Hoffman Estates
country: United States
facility: Site Reference ID/Investigator# 129380
state: Illinois
city: Cedarhurst
country: United States
facility: Site Reference ID/Investigator# 95379
state: New York
city: Rochester
country: United States
facility: Site Reference ID/Investigator# 95392
state: New York
city: Philadelphia
country: United States
facility: Site Reference ID/Investigator# 95388
state: Pennsylvania
city: DeSoto
country: United States
facility: Site Reference ID/Investigator# 95402
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 95393
state: Texas
city: Chita
country: Russian Federation
facility: Site Reference ID/Investigator# 117189
city: Ekaterinburg
country: Russian Federation
facility: Site Reference ID/Investigator# 117178
city: Kazan
country: Russian Federation
facility: Site Reference ID/Investigator# 117188
city: Lipetsk
country: Russian Federation
facility: Site Reference ID/Investigator# 117175
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 117159
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 117183
city: Novosibirsk
country: Russian Federation
facility: Site Reference ID/Investigator# 117182
city: Saint-Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 117195
city: Saratov
country: Russian Federation
facility: Site Reference ID/Investigator# 117156
city: Saratov
country: Russian Federation
facility: Site Reference ID/Investigator# 117177
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 117157
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 117185
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 117192
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 117193
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 117176
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 117186
city: Stavropol
country: Russian Federation
facility: Site Reference ID/Investigator# 117180
city: Yaroslavl
country: Russian Federation
facility: Site Reference ID/Investigator# 117181
city: Yekaterinburg
country: Russian Federation
facility: Site Reference ID/Investigator# 117194
city: Edinburgh
country: United Kingdom
facility: Site Reference ID/Investigator# 117422
city: London
country: United Kingdom
facility: Site Reference ID/Investigator# 117423
city: London
country: United Kingdom
facility: Site Reference ID/Investigator# 117425
city: Newcastle upon Tyne
country: United Kingdom
facility: Site Reference ID/Investigator# 117424
city: Oxford
country: United Kingdom
facility: Site Reference ID/Investigator# 117419
Study officials:
affiliation: AbbVie
name: George Haig, PharmD
role: STUDY_DIRECTOR
References:
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.