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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005661-13 | EudraCT Number |
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Study endpoint in preceding base study M10-855 not met.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-126 low dose | Experimental | ABT-126 low dose |
|
| ABT-126 middle dose | Experimental | ABT-126 middle dose |
|
| ABT-126 high dose | Experimental | ABT-126 high dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-126 | Drug | capsule(s) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) | rater based interview | from Day -1 to Week 52 |
| Change in University of California San Diego Performance-Based Skills Assessment-2 (UPSA-2ER) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Haig, PharmD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 95398 | Chino | California | 91710 | United States | ||
| Site Reference ID/Investigator# 95381 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27319970 | Result | 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. |
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rater based interview to evaluate functioning |
| from Day -1 to Week 52 |
| Change in the Positive and Negative Syndrome Scale (PANSS) | rater based interview to assess functioning | from Day -1 to Week 52 |
| Change in the 16-item version of the Negative Symptom Assessment Scale (NSA-16) | rater based interview to assess symptom severity | from Day -1 to Week 52 |
| Costa Mesa |
| California |
| 92626 |
| United States |
| Site Reference ID/Investigator# 95400 | Escondido | California | 92025 | United States |
| Site Reference ID/Investigator# 95406 | Garden Grove | California | 92845 | United States |
| Site Reference ID/Investigator# 95378 | National City | California | 91950 | United States |
| Site Reference ID/Investigator# 95390 | Norwalk | California | 90650 | United States |
| Site Reference ID/Investigator# 95386 | Oakland | California | 94612 | United States |
| Site Reference ID/Investigator# 95391 | Oceanside | California | 92056 | United States |
| Site Reference ID/Investigator# 95380 | Orange | California | 92868 | United States |
| Site Reference ID/Investigator# 95395 | Pico Rivera | California | 90660 | United States |
| Site Reference ID/Investigator# 95403 | Riverside | California | 92506 | United States |
| Site Reference ID/Investigator# 128356 | San Bernardino | California | 92408 | United States |
| Site Reference ID/Investigator# 95405 | San Diego | California | 92102 | United States |
| Site Reference ID/Investigator# 95397 | San Diego | California | 92103 | United States |
| Site Reference ID/Investigator# 95384 | San Gabriel | California | 91776 | United States |
| Site Reference ID/Investigator# 95385 | Santa Ana | California | 92705 | United States |
| Site Reference ID/Investigator# 95387 | Torrance | California | 90502 | United States |
| Site Reference ID/Investigator# 95382 | New Haven | Connecticut | 06519 | United States |
| Site Reference ID/Investigator# 95399 | Atlanta | Georgia | 30308 | United States |
| Site Reference ID/Investigator# 95377 | Marietta | Georgia | 30060 | United States |
| Site Reference ID/Investigator# 120595 | Chicago | Illinois | 60640 | United States |
| Site Reference ID/Investigator# 129380 | Hoffman Estates | Illinois | 60169 | United States |
| Site Reference ID/Investigator# 95379 | Cedarhurst | New York | 11516 | United States |
| Site Reference ID/Investigator# 95392 | Rochester | New York | 14623 | United States |
| Site Reference ID/Investigator# 95388 | Philadelphia | Pennsylvania | 19139 | United States |
| Site Reference ID/Investigator# 95402 | DeSoto | Texas | 75115 | United States |
| Site Reference ID/Investigator# 95393 | Houston | Texas | 77008 | United States |
| Site Reference ID/Investigator# 117189 | Chita | 672090 | Russia |
| Site Reference ID/Investigator# 117188 | Kazan' | 420061 | Russia |
| Site Reference ID/Investigator# 117175 | Lipetsk | 399083 | Russia |
| Site Reference ID/Investigator# 117159 | Moscow | 109559 | Russia |
| Site Reference ID/Investigator# 117183 | Moscow | 115419 | Russia |
| Site Reference ID/Investigator# 117182 | Novosibirsk | 630091 | Russia |
| Site Reference ID/Investigator# 117157 | Saint Petersburg | 190020 | Russia |
| Site Reference ID/Investigator# 117185 | Saint Petersburg | 190121 | Russia |
| Site Reference ID/Investigator# 117192 | Saint Petersburg | 191119 | Russia |
| Site Reference ID/Investigator# 117193 | Saint Petersburg | 191119 | Russia |
| Site Reference ID/Investigator# 117176 | Saint Petersburg | 192019 | Russia |
| Site Reference ID/Investigator# 117195 | Saint Petersburg | 195176 | Russia |
| Site Reference ID/Investigator# 117186 | Saint Petersburg | 197341 | Russia |
| Site Reference ID/Investigator# 117156 | Saratov | 410028 | Russia |
| Site Reference ID/Investigator# 117177 | Saratov | 410060 | Russia |
| Site Reference ID/Investigator# 117180 | Stavropol | 357034 | Russia |
| Site Reference ID/Investigator# 117181 | Yaroslavl | 150003 | Russia |
| Site Reference ID/Investigator# 117194 | Yekaterinburg | 620028 | Russia |
| Site Reference ID/Investigator# 117178 | Yekaterinburg | 620030 | Russia |
| Site Reference ID/Investigator# 117422 | Edinburgh | EH10 5HF | United Kingdom |
| Site Reference ID/Investigator# 117423 | London | SE5 8AF | United Kingdom |
| Site Reference ID/Investigator# 117425 | London | W6 8RP | United Kingdom |
| Site Reference ID/Investigator# 117424 | Newcastle upon Tyne | NE4 5PL | United Kingdom |
| Site Reference ID/Investigator# 117419 | Oxford | OX3 7JX | United Kingdom |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000618299 | ABT-126 |
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