Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is to evaluate safety, efficacy and pharmacokinetics of intravenously administered fosphenytoin in patients with neurosurgery, head trauma, epilepsy or status epilepticus who are requiring a loading dose of phenytoin.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15mg/kg of loading dose | Experimental |
| |
| 18mg/kg of loading dose | Experimental |
| |
| 22.5mg/kg of loading dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fosphenytoin | Drug | 15mg/kg, 18mg/kg or 22.5mg/kg of loading doses of fosphenytoin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | 8 to 12 days |
| Measure | Description | Time Frame |
|---|---|---|
| frequency and nature of seizures | 8 to 12 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eiji Nakagawa, M.D. | National Center of Neurology and Psychiatry | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Center of Neurology and Psychiatry | Kodaira | Tokyo | 187-8551 | Japan |
Not provided
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C043114 | fosphenytoin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided