CLINICAL TRIALS PROFILE FOR FOSPHENYTOIN SODIUM
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All Clinical Trials for FOSPHENYTOIN SODIUM
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT02920060 ↗ | Levetiracetam Versus Sodium Valproate in Children With Refractory Generalized Convulsive Status Epilepticus | Completed | Institute of Medical Sciences of the Banaras Hindu University (BHU),India | Phase 2 | 2015-01-01 | This study is a randomized, open label, parallel group,comparing the safety and efficacy of valproate and levetiracetam in patients of age group 1 to 16 years with status epilepticus not responded to phenytoin and benzodiazepines approaching to pediatric emergency , IMS, BHU. The primary outcome measures will be Proportion of children in either group who have Cessation of all clinical seizure within 30 min of drug administration and secondary outcome will be time taken to control seizure (minutes) from the initiation of infusion. Proportion of children in either group who required additional drugs to abort ongoing clinical seizures, rates of adverse events (hypotension, bradycardia, respiratory depression, PICU stay, in hospital mortality) in the two groups were measured. Refractory status epilepticus condition is major pediatric neurological emergency with high mortality and morbidity. Till now, the treatment guidelines for it are based primarily on retrospective studies with very few randomized studies. There is lack of sufficient data to recommend one drug over another for treatment of refractory status epilepticus. |
| NCT02920060 ↗ | Levetiracetam Versus Sodium Valproate in Children With Refractory Generalized Convulsive Status Epilepticus | Completed | Banaras Hindu University | Phase 2 | 2015-01-01 | This study is a randomized, open label, parallel group,comparing the safety and efficacy of valproate and levetiracetam in patients of age group 1 to 16 years with status epilepticus not responded to phenytoin and benzodiazepines approaching to pediatric emergency , IMS, BHU. The primary outcome measures will be Proportion of children in either group who have Cessation of all clinical seizure within 30 min of drug administration and secondary outcome will be time taken to control seizure (minutes) from the initiation of infusion. Proportion of children in either group who required additional drugs to abort ongoing clinical seizures, rates of adverse events (hypotension, bradycardia, respiratory depression, PICU stay, in hospital mortality) in the two groups were measured. Refractory status epilepticus condition is major pediatric neurological emergency with high mortality and morbidity. Till now, the treatment guidelines for it are based primarily on retrospective studies with very few randomized studies. There is lack of sufficient data to recommend one drug over another for treatment of refractory status epilepticus. |
| NCT05480553 ↗ | A Phase 3 Study of NPC-06 in Patients With Pain Associated With Acute Herpes Zoster | Not yet recruiting | Nobelpharma | Phase 3 | 2022-08-15 | To confirm the pain relief effect and the safety of NPC-06 (fosphenytoin sodium hydrate) in patients with pain associated with acute herpes zoster in a placebo-controlled, double-blind, parallel-group, comparative manner. |
| NCT06067412 ↗ | Efficacy of Phenytoin vs Levetiracetam in Status Epilepticus at Institute of Child Health,Faisalabad | Completed | Shaheed Zulfiqar Ali Bhutto Medical University | N/A | 2022-08-01 | Status epilepticus is the second most common neurologic emergency in children. Morbidity and mortality are considerable; thus, timely termination of convulsive status epilepticus is the primary goal of management to avoid these risks Our objective was to compare the efficacy of phenytoin and Levetiracetam in status epilepticus in children. This study was done in the pediatric emergency department of Children Hospital Faisalabad. A total of 70 patients were randomly allocated to one of the groups by a computer-generated random number table according to their admission in an emergency. Children in group A were given levetiracetam. Children in group B were given I/V phenytoin. For both groups if seizures recurred after the first loading dose an additional 10mg/kg of the same drug was given over 10 minutes. The patients were monitored to see whether there was any recurrence of seizure activity in the subsequent 24 hours. Seizure control was defined as the absence of seizure within 24 hours after the initial loading of the drug. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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