Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004844-23 | EudraCT Number |
Not provided
Not provided
Not provided
Toxic Epidermal Necrolysis
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the effect of AMG 747 on negative symptoms of schizophrenia in patients who are stable on current antipsychotic treatment. After a run-in period on their current antipsychotic treatment, patients will be randomized to one of the four treatment arms as add-on therapy for a treatment duration of up to 3 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 747 - Dose 1 | Experimental |
| |
| AMG 747 - Dose 2 | Experimental |
| |
| AMG 747 - Dose 3 | Experimental |
| |
| Placebo Comparator | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 747 | Drug | Three dose levels once-daily oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to week 12 in negative symptoms, as measured by the NSA-16 total score | NSA-16 = 16-item Negative Symptom Assessment Scale, an efficacy scale used for the primary endpoint | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Response defined as a ≥ 20% decrease in the NSA-16 total score at week 12 | NSA-16 = 16-item Negative Symptom Assessment Scale | 12 weeks |
| Change from baseline to week 12 on the PANSS total score and Marder factor scores |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Anaheim | California | 92804 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28433500 | Derived | Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20. | |
| 27789188 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Once-daily oral administration |
|
Positive and Negative Syndrome Scale (PANSS)
| 12 weeks |
| Change from baseline to week 12 on the CGI-S | Clinical Global Impression Severity Scale (CGI-S) | Week 12 |
| CGI-I scores at week 12 | Clinical Global Impression Improvement (CGI-I) | 12 weeks |
| Change on cognition battery | 12 weeks |
| Change in personal and social functioning | 12 weeks |
| Change on patient reported outcomes | 12 weeks |
| Cerritos |
| California |
| 90703 |
| United States |
| Research Site | Culver City | California | 90230 | United States |
| Research Site | Garden Grove | California | 92845 | United States |
| Research Site | Los Angeles | California | 90073 | United States |
| Research Site | Norwalk | California | 90650 | United States |
| Research Site | San Bernardino | California | 92408 | United States |
| Research Site | Torrance | California | 90502 | United States |
| Research Site | Washington D.C. | District of Columbia | 20016 | United States |
| Research Site | North Miami | Florida | 33161 | United States |
| Research Site | Atlanta | Georgia | 30308 | United States |
| Research Site | Chicago | Illinois | 60640 | United States |
| Research Site | Marlton | New Jersey | 08053 | United States |
| Research Site | Glen Oaks | New York | 11004 | United States |
| Research Site | Rochester | New York | 14618 | United States |
| Research Site | Raleigh | North Carolina | 27603 | United States |
| Research Site | Dayton | Ohio | 45417 | United States |
| Research Site | Houston | Texas | 77008 | United States |
| Research Site | Glenside | South Australia | 5065 | Australia |
| Research Site | Melbourne | Victoria | 3004 | Australia |
| Research Site | Mount Claremont | Western Australia | 6010 | Australia |
| Research Site | Calgary | Alberta | T2N 4Z6 | Canada |
| Research Site | Penticton | British Columbia | V2A 4M4 | Canada |
| Research Site | Kingston | Ontario | K7L 4X3 | Canada |
| Research Site | Montreal | Quebec | H3A 1A1 | Canada |
| Research Site | Takapuna, Auckland | 1309 | New Zealand |
| Research Site | Khot'kovo | 141371 | Russia |
| Research Site | Moscow | 107076 | Russia |
| Research Site | Moscow | 115552 | Russia |
| Research Site | Saint Petersburg | 192019 | Russia |
| Research Site | Saratov | 410028 | Russia |
| Research Site | Singapore | 539747 | Singapore |
| Research Site | Santander | Cantabria | 39008 | Spain |
| Research Site | Barcelona | Catalonia | 08036 | Spain |
| Research Site | Cornellà de Llobregat | Catalonia | 08940 | Spain |
| Research Site | L'Hospitalet de Llobregat | Catalonia | 08907 | Spain |
| Research Site | Madrid | Madrid | 28009 | Spain |
| Research Site | Valencia | Valencia | 46010 | Spain |
| Dunayevich E, Buchanan RW, Chen CY, Yang J, Nilsen J, Dietrich JM, Sun H, Marder S. Efficacy and safety of the glycine transporter type-1 inhibitor AMG 747 for the treatment of negative symptoms associated with schizophrenia. Schizophr Res. 2017 Apr;182:90-97. doi: 10.1016/j.schres.2016.10.027. Epub 2016 Oct 24. |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000625754 | (R)-2-(4-(phenyl(3-(trifluoromethyl)phenyl)methyl)piperazin-1-yl)acetic acid |
Not provided
Not provided
Not provided