CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 31 enrolled
Drug / intervention
Padsevonil +4 moredrug
Likely dose
Not stated in 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.

Search/NCT03695094
NCT03695094Phase 1Completed
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A Multicenter, Open-label, Parallel-group Study in Study Participants With Epilepsy, to Evaluate the Effect of Oxcarbazepine on the Pharmacokinetics, Safety, and Tolerability of Padsevonil

UCB Biopharma S.P.R.L.·interventional·Posted Oct 3, 2018·Updated Jun 4, 2020

In Brief

A Phase 1 clinical trial evaluating Padsevonil, Oxcarbazepine, and 3 other interventions for Epilepsy. Completed, enrolled 31 participants across 2 sites in 2 countries.

Detailed Summary

The purpose of the study is to evaluate the effect of stable coadministered oxcarbazepine (OXC), on the pharmacokinetics (PK), safety, tolerability of padsevonil (PSL) and the plasma PK of PSL metabolites, UCB1431322-000 and UCB1447499-000, in study participants with epilepsy compared with study participants co-medicated with stable doses of levetiracetam (LEV), lamotrigine (LTG) or brivaracetam (BRV) therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesBulgaria, Netherlands
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedOct 3, 2018
Enrollment StartSep 18, 2018
Primary CompletionMay 18, 2019
Study CompletionMay 30, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.7 years ago

Interventions

Padsevonildrug

Padsevonil (PSL) will be dosed to steady state and the effect of background therapies on pharmacokinetics will be assessed

Oxcarbazepinedrug

Concomitant administration of oxcarbazepine (OXC) at therapeutic dosage

Levetiracetamdrug

Concomitant administration of levetiracetam (LEV) at therapeutic dosage

Lamotriginedrug

Concomitant administration of lamotrigine (LTG) at therapeutic dosage

Brivaracetamdrug

Concomitant administration of brivaracetam (BRV) at therapeutic dosage