Long-term Safety and Efficacy of ABT-126 in Subjects With Schizophrenia: An Extension Study for Subjects Completing Study M10-855 (NCT01655680)
- Registration Number
- NCT01834638
- Lead Sponsor
- AbbVie
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 268
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ABT-126 low dose ABT-126 ABT-126 low dose ABT-126 middle dose ABT-126 ABT-126 middle dose ABT-126 high dose ABT-126 ABT-126 high dose
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change in the Positive and Negative Syndrome Scale (PANSS) from Day -1 to Week 52 rater based interview to assess functioning
Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) from Day -1 to Week 52 rater based interview
Change in University of California San Diego Performance-Based Skills Assessment-2 (UPSA-2ER) from Day -1 to Week 52 rater based interview to evaluate functioning
Change in the 16-item version of the Negative Symptom Assessment Scale (NSA-16) from Day -1 to Week 52 rater based interview to assess symptom severity
Trial Locations
- Locations (51)
Site Reference ID/Investigator# 95395
🇺🇸Pico Rivera, California, United States
Site Reference ID/Investigator# 95387
🇺🇸Torrance, California, United States
Site Reference ID/Investigator# 95393
🇺🇸Houston, Texas, United States
Site Reference ID/Investigator# 95405
🇺🇸San Diego, California, United States
Site Reference ID/Investigator# 95385
🇺🇸Santa Ana, California, United States
Site Reference ID/Investigator# 95399
🇺🇸Atlanta, Georgia, United States
Site Reference ID/Investigator# 120595
🇺🇸Chicago, Illinois, United States
Site Reference ID/Investigator# 95388
🇺🇸Philadelphia, Pennsylvania, 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# 95390
🇺🇸Norwalk, California, United States
Site Reference ID/Investigator# 95398
🇺🇸Chino, California, United States
Site Reference ID/Investigator# 95380
🇺🇸Orange, California, United States
Site Reference ID/Investigator# 95397
🇺🇸San Diego, California, United States
Site Reference ID/Investigator# 95402
🇺🇸DeSoto, Texas, United States
Site Reference ID/Investigator# 117159
🇷🇺Moscow, Russian Federation
Site Reference ID/Investigator# 117182
🇷🇺Novosibirsk, Russian Federation
Site Reference ID/Investigator# 117195
🇷🇺Saint-Petersburg, Russian Federation
Site Reference ID/Investigator# 117156
🇷🇺Saratov, Russian Federation
Site Reference ID/Investigator# 117175
🇷🇺Lipetsk, Russian Federation
Site Reference ID/Investigator# 117157
🇷🇺St. Petersburg, Russian Federation
Site Reference ID/Investigator# 117185
🇷🇺St. Petersburg, Russian Federation
Site Reference ID/Investigator# 117192
🇷🇺St. Petersburg, Russian Federation
Site Reference ID/Investigator# 117193
🇷🇺St. Petersburg, Russian Federation
Site Reference ID/Investigator# 117194
🇷🇺Yekaterinburg, Russian Federation
Site Reference ID/Investigator# 117422
🇬🇧Edinburgh, United Kingdom
Site Reference ID/Investigator# 95381
🇺🇸Costa Mesa, California, United States
Site Reference ID/Investigator# 95400
🇺🇸Escondido, California, United States
Site Reference ID/Investigator# 95378
🇺🇸National City, California, United States
Site Reference ID/Investigator# 95406
🇺🇸Garden Grove, California, United States
Site Reference ID/Investigator# 95391
🇺🇸Oceanside, California, United States
Site Reference ID/Investigator# 95386
🇺🇸Oakland, California, United States
Site Reference ID/Investigator# 95384
🇺🇸San Gabriel, California, United States
Site Reference ID/Investigator# 95377
🇺🇸Marietta, Georgia, United States
Site Reference ID/Investigator# 95382
🇺🇸New Haven, Connecticut, United States
Site Reference ID/Investigator# 129380
🇺🇸Hoffman Estates, Illinois, United States
Site Reference ID/Investigator# 117178
🇷🇺Ekaterinburg, Russian Federation
Site Reference ID/Investigator# 117188
🇷🇺Kazan, Russian Federation
Site Reference ID/Investigator# 117177
🇷🇺Saratov, Russian Federation
Site Reference ID/Investigator# 117180
🇷🇺Stavropol, Russian Federation
Site Reference ID/Investigator# 117176
🇷🇺St. Petersburg, Russian Federation
Site Reference ID/Investigator# 117186
🇷🇺St. Petersburg, Russian Federation
Site Reference ID/Investigator# 117181
🇷🇺Yaroslavl, Russian Federation
Site Reference ID/Investigator# 117424
🇬🇧Newcastle upon Tyne, United Kingdom
Site Reference ID/Investigator# 117419
🇬🇧Oxford, United Kingdom
Site Reference ID/Investigator# 117423
🇬🇧London, United Kingdom
Site Reference ID/Investigator# 117425
🇬🇧London, United Kingdom
Site Reference ID/Investigator# 95403
🇺🇸Riverside, California, United States
Site Reference ID/Investigator# 128356
🇺🇸San Bernardino, California, United States
Site Reference ID/Investigator# 117189
🇷🇺Chita, Russian Federation
Site Reference ID/Investigator# 117183
🇷🇺Moscow, Russian Federation