Overview

Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older

Status:
Completed

Trial end date:
2017-01-01

Target enrollment:
0

Participant gender:
All

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).

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

UCB BIOSCIENCES GmbH

Collaborator:

Eden Sarl

Treatments:

Carbamazepine
Lacosamide

Criteria

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