Schizophrenia Clinical Trial
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
| Verified date | October 2014 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Terminated |
| Enrollment | 268 |
| Est. completion date | November 2014 |
| Est. primary completion date | November 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 66 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | Site Reference ID/Investigator# 117189 | Chita | |
| Russian Federation | Site Reference ID/Investigator# 117178 | Ekaterinburg | |
| Russian Federation | Site Reference ID/Investigator# 117188 | Kazan | |
| Russian Federation | Site Reference ID/Investigator# 117175 | Lipetsk | |
| Russian Federation | Site Reference ID/Investigator# 117159 | Moscow | |
| Russian Federation | Site Reference ID/Investigator# 117183 | 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# 117177 | Saratov | |
| Russian Federation | Site Reference ID/Investigator# 117157 | St. Petersburg | |
| Russian Federation | Site Reference ID/Investigator# 117176 | St. Petersburg | |
| Russian Federation | Site Reference ID/Investigator# 117185 | St. Petersburg | |
| Russian Federation | Site Reference ID/Investigator# 117186 | 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# 117180 | Stavropol | |
| Russian Federation | Site Reference ID/Investigator# 117181 | Yaroslavl | |
| Russian Federation | Site Reference ID/Investigator# 117194 | Yekaterinburg | |
| United Kingdom | 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 States | Site Reference ID/Investigator# 95399 | Atlanta | Georgia |
| United States | Site Reference ID/Investigator# 95379 | Cedarhurst | New York |
| United States | Site Reference ID/Investigator# 120595 | Chicago | Illinois |
| United States | Site Reference ID/Investigator# 95398 | Chino | California |
| United States | Site Reference ID/Investigator# 95381 | Costa Mesa | California |
| United States | Site Reference ID/Investigator# 95402 | DeSoto | Texas |
| 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# 129380 | Hoffman Estates | Illinois |
| United States | Site Reference ID/Investigator# 95393 | Houston | Texas |
| United States | Site Reference ID/Investigator# 95377 | Marietta | Georgia |
| United States | Site Reference ID/Investigator# 95378 | National City | California |
| United States | Site Reference ID/Investigator# 95382 | New Haven | Connecticut |
| 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# 95388 | Philadelphia | Pennsylvania |
| 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# 95392 | Rochester | New York |
| United States | Site Reference ID/Investigator# 128356 | San Bernardino | California |
| United States | Site Reference ID/Investigator# 95397 | San Diego | California |
| United States | Site Reference ID/Investigator# 95405 | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
United States, Russian Federation, United Kingdom,
Haig G, Wang D, Othman AA, Zhao J. The a7 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):2893-29 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of subjects with adverse events | up to 52 weeks | ||
| Primary | Change in laboratory test results | from Day -1 to Week 52 | ||
| Primary | Change in vital signs | from Day -1 to Week 52 | ||
| Primary | Change in electrocardiogram (ECG) data | from Day -1 to Week 52 | ||
| Secondary | 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 | |
| Secondary | Change in University of California San Diego Performance-Based Skills Assessment-2 (UPSA-2ER) | rater based interview to evaluate functioning | from Day -1 to Week 52 | |
| Secondary | Change in the Positive and Negative Syndrome Scale (PANSS) | rater based interview to assess functioning | from Day -1 to Week 52 | |
| Secondary | 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 |
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