Study to Assess the Safety and Tolerability of Intravenous Carbamazepine in Adults With Epilepsy
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|ClinicalTrials.gov Identifier: NCT01128959|
Recruitment Status : Completed
First Posted : May 24, 2010
Results First Posted : December 5, 2016
Last Update Posted : January 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Intravenous Carbamazepine (IV CBZ)||Phase 3|
This was 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 included a 28 day Lead-in Period, a Confinement Period (up to 7 days and 6 nights) and a 28 day Follow-up Period.
Patients began 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 began the 24hr urine collection for evaluation of urinary biomarkers. All patients temporarily discontinued 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||108 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
|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.
- Adverse Events [ Time Frame: Baseline to after last iv dose on day 4 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01128959
|Study Director:||Email contact via H. Lundbeck A/S||LundbeckClinicalTrials@lundbeck.com|