Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UCB BIOSCIENCES GmbH
With
Eden Sarl
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older
