Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of oral Lacosamide as first add on treatment in subjects with uncontrolled partial-onset seizures after prior treatment with a monotherapy Antiepileptic Drug (AED) regimen compared to subjects who have received treatment with at least 2 AEDs.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Anticonvulsants; Lacosamide

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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

• Prior or concomitant Vigabatrin use