At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 108 enrolled
Drug / intervention
Intravenous Carbamazepine (IV CBZ)drug
Likely dose
Intravenous Carbamazepine (IV CBZ) 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open-Label Study to Assess the Safety and Tolerability of Intravenous Carbamazepine as Short-Term Replacement of Oral Carbamazepine in Adult Patients With Epilepsy
In Brief
A Phase 3 clinical trial evaluating Intravenous Carbamazepine (IV CBZ) for Epilepsy. Completed, enrolled 108 participants across 29 sites.
Detailed Summary
The purpose of this study is to assess the safety and tolerability of intravenous (IV) carbamazepine (CBZ) administered as multiple 15 minute infusions and a single 5 minute infusion to adult patients with epilepsy on stable higher doses of oral CBZ.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesUnited States
CollaboratorsLigand Pharmaceuticals, ICON Clinical Research, Quintiles, Inc.
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2010
Enrollment StartJun 2010
Primary CompletionJan 2013
TodayJul 2026
First PostedMay 24, 2010
Enrollment StartJun 1, 2010
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 16.1 years ago
Interventions
Intravenous Carbamazepine (IV CBZ)drug
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.