Status:
COMPLETED
Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older
Lead Sponsor:
UCB BIOSCIENCES GmbH
Collaborating Sponsors:
Eden Sarl
Conditions:
Epilepsy
Monotherapy
Eligibility:
All Genders
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
551 Patients enrolled
Trial Details
Trial ID
NCT01465997
Start Date
May 1 2012
End Date
January 1 2017
Last Update
July 18 2018
Active Locations (150)
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1
786
Alabaster, Alabama, United States
2
799
Huntsville, Alabama, United States
3
777
Little Rock, Arkansas, United States
4
789
Panama City, Florida, United States