Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older
Status: | Completed |
---|---|
Conditions: | Neurology, Neurology, Epilepsy |
Therapuetic Areas: | Neurology, Other |
Healthy: | No |
Age Range: | Any |
Updated: | 7/20/2018 |
Start Date: | May 2012 |
End Date: | January 2017 |
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.
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).
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).
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
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