Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UCB Pharma
The study consisted of 3 Periods: Period 1: a 1-week Screening Phase, Period 2: a 30-week Treatment Phase (consisting of a 6-week Titration Phase and a 24-week Maintenance Phase), and Period 3: a 3-week Taper/Safety Follow-Up Phase.
Age
17–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Group 1:
Subject has a diagnosis of epilepsy with simple partial seizures (motor component) and/or complex partial seizures with or without secondary generalization
Currently taking adequate monotherapy (defined as a single Antiepileptic Drug (AED) for at least 28 days prior to Screening) and has no history of AED polytherapy. Prior use of rescue medication (short-term intermittent use) is acceptable
Epilepsy diagnosis should be ≤24 months at the time of the Screening Visit
The minimum allowed seizure frequency at any time during the 12 weeks prior to the Screening Visit is ≥3 partial-onset seizures
Group 2:
Subject has a diagnosis of epilepsy with simple partial seizures (motor component) and/or complex partial seizures with or without secondary generalization
Currently taking 1 to 3 AEDs, and has tried at least 2 prior AED treatment regimens (concurrently or sequentially)
Epilepsy diagnosis should be ≥5 years at the time of the Screening Visit
The minimum allowed seizure frequency during the 12 weeks prior to the Screening Visit is ≥1 partial-onset seizure per 28 days
You may not be if
Previous use of Lacosamide
History of seizure disorder characterized primarily by isolated auras
History of primary generalized seizures
History of status epilepticus within last 12-months
History of cluster seizures during the 12 week period prior to Visit 1
Nonepileptic events, including pseudoseizures that could be confused with seizure
Lifetime history of suicide attempt or suicidal ideation in the past 6 months
Hypersensitivity to any component of Lacosamide
History of drug or alcohol abuse
History of an acute or subacutely progressive Central Nervous System (CNS) disease
Undergone cranial surgery within the last year prior to study entry
Concomitant treatment of Felbamate or previous Felbamate therapy within the last 6 months
