Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004845-42 | 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 | Little Rock | Arkansas | 72211 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27789188 | Derived | 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. |
| 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) | 12 weeks |
| 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 |
| Springdale |
| Arkansas |
| 72764 |
| United States |
| Research Site | Long Beach | California | 90813 | United States |
| Research Site | Oakland | California | 94612 | United States |
| Research Site | Orange | California | 92868 | United States |
| Research Site | Hialeah | Florida | 33018 | United States |
| Research Site | Kissimmee | Florida | 34741 | United States |
| Research Site | Atlanta | Georgia | 30328 | United States |
| Research Site | Rockville | Maryland | 20850 | United States |
| Research Site | Flowood | Mississippi | 39232 | United States |
| Research Site | Princeton | New Jersey | 08540 | United States |
| Research Site | Buffalo | New York | 14215 | United States |
| Research Site | New York | New York | 10027 | United States |
| Research Site | Durham | North Carolina | 27710 | United States |
| Research Site | Scranton | Pennsylvania | 18503 | United States |
| Research Site | Memphis | Tennessee | 38119 | United States |
| Research Site | Dallas | Texas | 75230 | United States |
| Research Site | Brno | 615 00 | Czechia |
| Research Site | Olomouc | 779 00 | Czechia |
| Research Site | Prague | 120 00 | Czechia |
| Research Site | Prague | 190 00 | Czechia |
| Research Site | Přerov | 750 01 | Czechia |
| Research Site | Strakonice | 386 29 | Czechia |
| Research Site | Créteil | 94010 | France |
| Research Site | Dôle | 39100 | France |
| Research Site | Montauban | 82013 | France |
| Research Site | Nîmes | 30029 | France |
| Research Site | Kuala Lumpur | Kuala Lumpur | 55100 | Malaysia |
| Research Site | Kuala Lumpur | Kuala Lumpur | 56000 | Malaysia |
| Research Site | Kuala Lumpur | Kuala Lumpur | 59100 | Malaysia |
| Research Site | Ipoh | Perak | 30450 | Malaysia |
| Research Site | Ipoh | Perak | 31250 | Malaysia |
| Research Site | Bydgoszcz | 85-096 | Poland |
| Research Site | Chełmno | 86-200 | Poland |
| Research Site | Katowice | 40-340 | Poland |
| Research Site | Skorzewo | 60-185 | Poland |
| Research Site | Torun | 87-100 | Poland |
| Research Site | Żuromin | 09-300 | Poland |
| Research Site | Barnet | EN5 3DJ | United Kingdom |
| Research Site | Edinburgh | EH10 5HF | United Kingdom |
| Research Site | London | SE5 8AF | United Kingdom |
| Research Site | Norwich | NR1 3RE | United Kingdom |
| Research Site | Sheffield | S10 3TH | United Kingdom |
| Research Site | Warrington | WA2 8WA | United Kingdom |
| 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