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| Name | Class |
|---|---|
| Tongji Hospital | OTHER |
| Michigan State University | OTHER |
| Juntendo University | OTHER |
| Technical University of Munich |
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Children with focal refractory epilepsy will be routinely included in the collection of history, blood routine, biochemistry, EEG, MRI and 18F-FDG PET to determine the location of the epileptogenic focus and to assess the severity of the disease. This international multicenter clinical trial uses a double-blind, randomized, controlled study to evaluate the safety and efficacy of LCM in clinical applications in children with epilepsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator |
| |
| Experimental group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide | Drug | The experimental group will be given oral lacosamide supplementation on the basis of the original antiepileptic drugs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of weekly seizures (times/week) | The reduction of absolute number of weekly seizures in the 16-week treatment period compared with the retrospective baseline period | 16-week |
| Assessment of liver function by serum alanine aminotransferase (U/L) | The serum alanine aminotransferase (blood biochemistry) will be performed at baseline, at the 3rd and 6th visits to monitor the liver function of patients. | One year |
| Assessment of renal function by serum creatinine (umol/L) | The serum creatinine (blood biochemistry) will be performed at baseline, at the 3rd and 6th visits to monitor the renal function of patients. | One year |
| Assessment of white blood cell count ( /L) | The white blood cell count (blood routine) will be performed at baseline, at the 3rd and 6th visits to monitor the renal function of patients. | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Wang | Contact | +86 057187767138 | wangjing5678@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nuclear Medicine and PET/CT Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000078334 | Lacosamide |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| OTHER |
| RIKEN | OTHER |
| University of California, Los Angeles | OTHER |
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| Placebo oral tablet | Drug | The control group will be given oral placebo supplementation on the basis of the original antiepileptic drugs. |
|
| Acids, Acyclic |
| D002264 | Carboxylic Acids |