Long-term Safety and Efficacy of ABT-126 in Subjects With Schizophrenia: An Extension Study for Subjects Completing Study M10-855 (NCT01655680)
Sponsor
AbbVie (Industry)
Overall Status
Terminated
CT.gov ID
NCT01834638
Collaborator
(none)
268
51
3
20
5.3
0.3
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
268 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date
:
Mar 1, 2013
Actual Primary Completion Date
:
Nov 1, 2014
Actual Study Completion Date
:
Nov 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ABT-126 low dose ABT-126 low dose |
Drug: ABT-126
capsule(s)
|
| Experimental: ABT-126 middle dose ABT-126 middle dose |
Drug: ABT-126
capsule(s)
|
| Experimental: ABT-126 high dose ABT-126 high dose |
Drug: ABT-126
capsule(s)
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 Positive and Negative Syndrome Scale (PANSS) [from Day -1 to Week 52]
rater based interview to assess 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 66 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site Reference ID/Investigator# 95398 | Chino | California | United States | 91710 |
| 2 | Site Reference ID/Investigator# 95381 | Costa Mesa | California | United States | 92626 |
| 3 | Site Reference ID/Investigator# 95400 | Escondido | California | United States | 92025 |
| 4 | Site Reference ID/Investigator# 95406 | Garden Grove | California | United States | 92845 |
| 5 | Site Reference ID/Investigator# 95378 | National City | California | United States | 91950 |
| 6 | Site Reference ID/Investigator# 95390 | Norwalk | California | United States | 90650 |
| 7 | Site Reference ID/Investigator# 95386 | Oakland | California | United States | 94612 |
| 8 | Site Reference ID/Investigator# 95391 | Oceanside | California | United States | 92056 |
| 9 | Site Reference ID/Investigator# 95380 | Orange | California | United States | 92868 |
| 10 | Site Reference ID/Investigator# 95395 | Pico Rivera | California | United States | 90660 |
| 11 | Site Reference ID/Investigator# 95403 | Riverside | California | United States | 92506 |
| 12 | Site Reference ID/Investigator# 128356 | San Bernardino | California | United States | 92408 |
| 13 | Site Reference ID/Investigator# 95405 | San Diego | California | United States | 92102 |
| 14 | Site Reference ID/Investigator# 95397 | San Diego | California | United States | 92103 |
| 15 | Site Reference ID/Investigator# 95384 | San Gabriel | California | United States | 91776 |
| 16 | Site Reference ID/Investigator# 95385 | Santa Ana | California | United States | 92705 |
| 17 | Site Reference ID/Investigator# 95387 | Torrance | California | United States | 90502 |
| 18 | Site Reference ID/Investigator# 95382 | New Haven | Connecticut | United States | 06519 |
| 19 | Site Reference ID/Investigator# 95399 | Atlanta | Georgia | United States | 30308 |
| 20 | Site Reference ID/Investigator# 95377 | Marietta | Georgia | United States | 30060 |
| 21 | Site Reference ID/Investigator# 120595 | Chicago | Illinois | United States | 60640 |
| 22 | Site Reference ID/Investigator# 129380 | Hoffman Estates | Illinois | United States | 60169 |
| 23 | Site Reference ID/Investigator# 95379 | Cedarhurst | New York | United States | 11516 |
| 24 | Site Reference ID/Investigator# 95392 | Rochester | New York | United States | 14623 |
| 25 | Site Reference ID/Investigator# 95388 | Philadelphia | Pennsylvania | United States | 19139 |
| 26 | Site Reference ID/Investigator# 95402 | DeSoto | Texas | United States | 75115 |
| 27 | Site Reference ID/Investigator# 95393 | Houston | Texas | United States | 77008 |
| 28 | Site Reference ID/Investigator# 117189 | Chita | Russian Federation | 672090 | |
| 29 | Site Reference ID/Investigator# 117178 | Ekaterinburg | Russian Federation | 620030 | |
| 30 | Site Reference ID/Investigator# 117188 | Kazan | Russian Federation | 420061 | |
| 31 | Site Reference ID/Investigator# 117175 | Lipetsk | Russian Federation | 399083 | |
| 32 | Site Reference ID/Investigator# 117159 | Moscow | Russian Federation | 109559 | |
| 33 | Site Reference ID/Investigator# 117183 | Moscow | Russian Federation | 115419 | |
| 34 | Site Reference ID/Investigator# 117182 | Novosibirsk | Russian Federation | 630091 | |
| 35 | Site Reference ID/Investigator# 117195 | Saint-Petersburg | Russian Federation | 195176 | |
| 36 | Site Reference ID/Investigator# 117156 | Saratov | Russian Federation | 410028 | |
| 37 | Site Reference ID/Investigator# 117177 | Saratov | Russian Federation | 410060 | |
| 38 | Site Reference ID/Investigator# 117157 | St. Petersburg | Russian Federation | 190020 | |
| 39 | Site Reference ID/Investigator# 117185 | St. Petersburg | Russian Federation | 190121 | |
| 40 | Site Reference ID/Investigator# 117192 | St. Petersburg | Russian Federation | 191119 | |
| 41 | Site Reference ID/Investigator# 117193 | St. Petersburg | Russian Federation | 191119 | |
| 42 | Site Reference ID/Investigator# 117176 | St. Petersburg | Russian Federation | 192019 | |
| 43 | Site Reference ID/Investigator# 117186 | St. Petersburg | Russian Federation | 197341 | |
| 44 | Site Reference ID/Investigator# 117180 | Stavropol | Russian Federation | 357034 | |
| 45 | Site Reference ID/Investigator# 117181 | Yaroslavl | Russian Federation | 150003 | |
| 46 | Site Reference ID/Investigator# 117194 | Yekaterinburg | Russian Federation | 620028 | |
| 47 | Site Reference ID/Investigator# 117422 | Edinburgh | United Kingdom | EH10 5HF | |
| 48 | Site Reference ID/Investigator# 117423 | London | United Kingdom | SE5 8AF | |
| 49 | Site Reference ID/Investigator# 117425 | London | United Kingdom | W6 8RP | |
| 50 | Site Reference ID/Investigator# 117424 | Newcastle upon Tyne | United Kingdom | NE4 5PL | |
| 51 | Site Reference ID/Investigator# 117419 | Oxford | United Kingdom | OX3 7JX |
Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: George Haig, PharmD, AbbVie
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
AbbVie
ClinicalTrials.gov Identifier:
NCT01834638
Other Study ID Numbers:
- M13-765
- 2012-005661-13
First Posted:
Apr 18, 2013
Last Update Posted:
May 2, 2018
Last Verified:
Oct 1, 2014