CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 551 enrolled
Drug / intervention
Lacosamide +1 moredrug
Likely dose
Lacosamide 100 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.

Search/NCT01465997
NCT01465997Phase 3Completed
CompareCT.gov

A Multicenter, Double-blind, Double-dummy, Follow up Study Evaluating the Long-term Safety of Lacosamide in Comparison With Controlled-release Carbamazepine Used as Monotherapy in Subjects With Partial-onset or Generalized Tonic-clonic Seizures ≥16 Years of Age Coming From the SP0993 Study.

UCB BIOSCIENCES GmbH·interventional·Posted Nov 7, 2011·Updated Jul 18, 2018

In Brief

A Phase 3 clinical trial evaluating Lacosamide and Carbamazepine-Controlled Release (CBZ-CR) for Epilepsy and Monotherapy. Completed, enrolled 551 participants across 150 sites in 29 countries.

Detailed Summary

Compare safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with primary safety variables including spontaneous reports of Adverse Events (AEs), withdrawal of subjects due to AEs, reporting of Serious AEs (SAEs).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Monotherapy
CountriesAustralia, Belgium, Bulgaria, Canada, Czechia, Finland, France, Germany, Greece, Hungary, Italy, Japan, Latvia, Lithuania, Mexico, Philippines, Poland, Portugal, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Switzerland, Thailand, Ukraine, United Kingdom, United States
CollaboratorsEden Sarl

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 7, 2011
Enrollment StartMay 1, 2012
Primary CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 14.7 years ago

Interventions

Lacosamidedrug

50 and 100 mg tablets of Lacosamide given as 100 mg/day, 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years)

Carbamazepine-Controlled Release (CBZ-CR)drug

200 mg tablets of Carbamazepine-CR given as 200 mg/day, 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum 3.5 Years)