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A randomized, double-blind, positive drug/placebo parallel controlled, multicenter, phase III clinical trial of L-oxiracetam injection to improve memory and cognitive Impairment in patients with craniocerebral injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L-oxiracetam | Active Comparator |
| |
| Oxiracetam | Active Comparator |
| |
| Plaecbo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test group: L-oxiracetam Injection | Drug | L-oxiracetam injection, 4 vials, once a day, IV. Placebo injection of oxiracetam, 6 vials, once a day, IV. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The difference of Loewenstein Occupational Therapy Cognitive Assessment (LOCTA) scores between baseline and 3 months after administration of drugs. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tie Xu, Master | Contact | 86-18036618680 | xutie@yoko-bio.com | |
| Huiwen Jiao, Master | Contact | 86-15850633389 | jiaohuiwen@yoko-bio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Tianjin Medical University | Recruiting | Tianjing | Tianjing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41381424 | Derived | Liu T, Wang J, Zhao Z, Jiang W, Zhang M, Yu Y, Liu Y, Liu M, Chen L, Zhang H, Hong Y, Li B, Yu R, Ji H, Mi L, Zhao B, Lv C, Liu C, Zhang J, Jiang R; LOCATE Trial Investigators. Efficacy and safety of L-oxiracetam on cognitive function in patients with traumatic brain injury: a multicentre, randomised, double-blind, phase 3 clinical trial. Signal Transduct Target Ther. 2025 Dec 12;10(1):401. doi: 10.1038/s41392-025-02492-5. | |
| 38975302 |
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| ID | Term |
|---|---|
| D006259 | Craniocerebral Trauma |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D003072 | Cognition Disorders |
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| Control group: Oxiracetam Injection | Drug | Placebo injection of l-oxiracetam, 4 vials, once a day, IV. Oxiracetam injection, 6 vials, once a day, IV. |
|
| Placebo group: Placebo Injection | Drug | Placebo injection of l-oxiracetam, 4 vials, once a day, IV. Placebo injection of oxiracetam, 6 vials, once a day, IV. |
|
| Derived |
| Liu T, Liu M, Nie M, Zhao Z, Liu X, Qian Y, Yu Y, Sha Z, Wu C, Yuan J, Jiang W, Lv C, Mi L, Tian Y, Zhang J, Jiang R. Effect of l-oxiracetam and oxiracetam on memory and cognitive impairment in mild-to-moderate traumatic brain injury patients: Study protocol for a randomized controlled trial. Aging Med (Milton). 2024 Jun 14;7(3):341-349. doi: 10.1002/agm2.12335. eCollection 2024 Jun. |
| D019965 |
| Neurocognitive Disorders |
| D001523 | Mental Disorders |