The Study of NPC-06 - Investigation of Safety, Efficacy and Pharmacokinetics of Fosphenytoin

Nobelpharma Co., Ltd.

Status and phase: Completed; Phase 3

Conditions: Epilepsy

Treatments: Drug: fosphenytoin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00908453

NPC-06-2

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male or female, hospitalized patients 2 years of age or older
• Adult patients or guardian for pediatric patients to provide written informed consent

Exclusion criteria

• patient with a history of hypersensitivity to hydantoins
• patient with hypotension, sinus bradycardia, sino-atrial block, second or third degree A-V block, or Adams-Stokes syndrome
• pregnant or nursing female patients

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 3 patient groups

15mg/kg of loading dose

Experimental group

Treatment:

Drug: fosphenytoin

18mg/kg of loading dose

Experimental group

Treatment:

Drug: fosphenytoin

22.5mg/kg of loading dose

Experimental group

Treatment:

Drug: fosphenytoin