Study to Assess the Safety and Tolerability of Intravenous Carbamazepine in Adults With Epilepsy
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-Label Study to Assess the Safety and Tolerability of Intravenous Carbamazepine as Short-Term Replacement of Oral Carbamazepine in Adult Patients With Epilepsy|
- The primary objective to assess the safety and tolerability of IV CBZ administered as multiple 15 minute infusions to adult patients with epilepsy on stable higher doses of oral CBZ includes adverse events, laboratory test results, and ECG parameters [ Time Frame: 13 infusions administered across 4 days ] [ Designated as safety issue: Yes ]
- For the secondary objective to assess biomarkers for renal effect of IV CBZ, the variables of interest include the analytes collected in the 24-hour urine collection relative to the creatinine volume excreted [ Time Frame: Measures will be taken across all days of IV infusion (4 days) ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2010|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
|Experimental: Intravenous Carbamazepine (IV CBZ)||
Drug: Intravenous Carbamazepine (IV CBZ)
10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01128959
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|Study Director:||Email contact via H. Lundbeck A/S||LundbeckClinicalTrials@lundbeck.com|