Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UCB BIOSCIENCES, Inc.
With
UCB Biopharma SRL
Age
0–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form (ICF) is signed and dated by the subject or legal representative. The ICF or a specific Assent form, where required, will be signed and dated by minors
Subject has completed the Transition Period of SP0967 \[NCT02477839\] or SP0969 \[NCT01921205\] for the treatment of uncontrolled partial-onset seizures in pediatric epilepsy
Subject is expected to benefit from participation, in the opinion of the investigator
Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the investigator
Subject is male or female aged 1 month to ≤17 years
Subject has a diagnosis of epilepsy with partial-onset seizures
You may not be if
Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
Subject meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for SP0967 or SP0969, or is experiencing an ongoing serious adverse event (SAE)
For subjects ≥6 years of age, subject has a lifetime history of suicide attempt (including an actual 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 Visit 1
Female subject who is pregnant or nursing, and/or a female subject of childbearing potential who is not surgically sterile or does not practice 1 highly effective method of contraception
Clareo Health | A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures
