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Following a pre-specified interim analysis and Data Monitoring Committee recommendation due to insufficient level of efficacy
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AVE1625 is a new potent and selective cannabinoid 1 (CB1) antagonist in clinical development for the treatment of cognitive impairment in patients diagnosed with schizophrenia.
The main objective of this study is to evaluate the efficacy on cognitive impairment of 3 doses of AVE1625 using a new cognitive battery called Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) in schizophrenic patients.
The secondary objectives are to measure the efficacy of AVE1625 on functional capacity of the patients using a specific scale called University of California San Diego Performance-based Skills Assessment 2 (UPSA2) and to assess the safety of the compound.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| AVE1625 dose level 1 | Experimental |
| |
| AVE1625 dose level 2 | Experimental |
| |
| AVE1625 dose level 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVE1625 | Drug | oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the MATRICS Cognitive Battery composite standardized score | at week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the UPSA2 total score | at week 24 | |
| Additional scales used for schizophrenia | at week 24 | |
| Safety: physical examination, vital signs, ECGs, laboratory parameters, adverse events |
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Inclusion Criteria:
Exclusion Criteria:
The investigator will evaluate whether there are other reasons why a patient may not participate.
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| Name | Affiliation | Role |
|---|---|---|
| ICD CSD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | 08807 | United States | ||
| Sanofi-Aventis Administrative Office |
| 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. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C523652 | AVE1625 |
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| placebo | Drug | oral administration |
|
| study period |
| Laval |
| Canada |