Overview

This trial is active, not recruiting.

Conditions epilepsy, monotherapy
Treatments lacosamide, carbamazepine-controlled release (cbz-cr)
Phase phase 3
Sponsor UCB BIOSCIENCES GmbH
Collaborator Eden Sarl
Start date May 2012
End date December 2016
Trial size 551 participants
Trial identifier NCT01465997, 2010-021238-74, SP0994

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
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)
lacosamide VIMPAT film-coated tablets
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)
(Active Comparator)
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 of 3.5 Years)
carbamazepine-controlled release (cbz-cr) Tegretol® Retard Tablets 200 mg
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)

Primary Outcomes

Measure
Number of subjects with at least one treatment-emergent Adverse Event (AE) during the Treatment Phase (Maximum of 3.5 Years)
time frame: Duration of the Treatment Phase (Maximum of 3.5 Years)
Number of subjects who withdrew from the study due to a treatment-emergent Adverse Event (AE) during the Treatment Phase (Maximum 3.5 Years)
time frame: Duration of the Treatment Phase (Maximum of 3.5 Years)
Number of subjects with at least one treatment- emergent Serious Adverse Event (SAE) during the Treatment Phase (Maximum of 3.5 years)
time frame: Duration of the Treatment Phase (Maximum of 3.5 Years)

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Subject/legal representative is considered reliable and capable of adhering to the protocol - Subject has remained seizure free and completed the Maintenance Phase of the SP0993; or subject has experienced 1 or more seizures on the first or second target dose during the SP0993 Maintenance Phase - Subject is expected to benefit from participation in SP0994 in the opinion of the investigator Exclusion Criteria: - Subject is receiving any investigational drugs or using any experimental devices in addition to LCM or CBZ-CR - Subject experienced a seizure at the third target dose during the Evaluation Phase or Maintenance Phase of the SP0993 study - Subject is taking benzodiazepines for a non-epilepsy indication - Subject meets a withdrawal criterion from the previous study SP0993 - Subject is experiencing an ongoing SAE from the previous study SP0993 - Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (Yes) to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening. Or subject has a positive response (Yes) to either Question 4 or Question 5 of the C-SSRS at Screening in the "Since Last Visit" version

Additional Information

Official title 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by UCB Pharma.