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Study to Assess the Safety and Tolerability of Intravenous Carbamazepine in Adults With Epilepsy

2014-07-23 21:08:59 | BioPortfolio

Summary

The purpose of this study is to assess the safety and tolerability of intravenous (IV) carbamazepine (CBZ) administered as multiple 15 minute infusions to adult patients with epilepsy on stable higher doses of oral CBZ.

Description

This is a phase III, multicenter, open-label study designed to assess the safety and tolerability of intravenously administered CBZ in adult patients with epilepsy. This study will include a 28 day Lead-in Period, a Confinement Period (up to 7 days and 6 nights) and a 28 day Follow-up Period.

Patients will begin confinement on Day -1 of the trial, continuing to take their oral CBZ as prescribed by the investigator. On the morning of Day 0, Day 4, and Day 17, patients will begin the 24hr urine collection for evaluation of urinary biomarkers. All patients will temporarily discontinue their prescribed oral CBZ and begin IV CBZ administration on the morning of Day 1, continuing administrations every 6 hours (Q6h) through the morning of Day 4.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Epilepsy

Intervention

Intravenous Carbamazepine (IV CBZ)

Location

Neurological Clinic of Texas, P.A.
Dallas
Texas
United States
75230

Status

Recruiting

Source

Lundbeck Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:59-0400

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