At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 14 enrolled
Drug / intervention
Eslicarbazepine acetate +1 moredrug
Likely dose
Eslicarbazepine acetate 600 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.
A Phase I, Single Centre, Open, Randomised, Parallel Study to Evaluate the Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine in Healthy Subject
In Brief
A Phase 1 clinical trial evaluating Eslicarbazepine acetate and Oxcarbazepine for Partial Epilepsy. Completed, enrolled 14 participants across 1 site.
Detailed Summary
This purpose of this study is to measure the concentrations of two anti-epileptic drugs (Eslicarbazepine acetate and oxcarbazepine) and their metabolites in the cerebrospinal fluid and blood plasma of healthy subjects and also to assess how these drugs are tolerated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPartial Epilepsy
CountriesBelgium
Collaborators--
Timeline
Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2008
Primary CompletionDec 2008
Study CompletionFeb 2009
First PostedMay 2009
TodayJul 2026
First PostedMay 12, 2009
Enrollment StartNov 1, 2008
Primary CompletionDec 1, 2008
Study CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.1 years ago
Interventions
Eslicarbazepine acetatedrug
Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9
Oxcarbazepinedrug
Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)