Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UCB BIOSCIENCES, Inc.
Age
4–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
\- Subject must have completed or be an eligible Baseline failure from the parent study (SP0982 \[NCT02408523\]). Note: Other subjects screened for SP0982 may be considered for roll-over to EP0012 if the investigator considers that the subject could benefit from treatment with open-label lacosamide (LCM) and based on prior discussion with and approval from the UCB Study Physician or representative
You may not be if
Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
Subject meets the withdrawal criteria for SP0982 or is experiencing an ongoing serious adverse event (SAE)
Subject has an active suicidal ideation as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Since Last Visit" version of the Columbia-Suicide Severity Rating Scale (C-SSRS)
Subject has \>=2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \>ULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are \>ULN and \<1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin \<35%). For all subjects who entered EP0012 directly with a Baseline result \>ULN for ALT, AST, ALP, or total bilirubin, a Baseline diagnosis and/or the cause of any clinically meaningful elevation must be understood and recorded in the electronic Case Report form (eCRF). Tests that result in ALT, AST, or ALP up to 25% above the exclusion limit may be repeated once for confirmation.
