Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures

Conditions	Phase	Intervention Type
Epilepsy	Phase 3	Drug Lacosamide Drug Lacosamide

View trial NCT00520741 on www.clinicaltrials.gov

Contacts

Please use the information below to contact the trial coordinators.

UCB Clinical Trial Call Center

+877 822 9493

Eligibility

Ages Eligible for Study: 16 years to 70 years
Genders Eligible for Study: Both

Keywords

Epilepsy, Partial Onset Seizures, Lacosamide, Monotherapy, and Vimpat

Inclusion Criteria

- Subject has a diagnosis of Epilepsy with Simple Partial Seizures (motor component)
and or Complex Partial Seizures (with or without secondary generalization)

- Must be experiencing 2 to 40 seizures per 28-day period

- Stable dose of 1 or 2 marketed antiepileptic drugs

- Second Antiepileptic Drug (AED) must be less than or equal to 50 % of the minimum
recommended maintenance dose per USA product label at screening

Exclusion Criteria

- Subject has a history of primary generalized or unclassified seizures

- Seizure disorder primarily characterized by isolated auras

- History of status epilepticus

- Seizures that are uncountable due to clustering

- Has greater than 5 seizures/day

- Subjects taking Benzodiazepines, Phenobarbital or Primidone

- Subject has Vagus Nerve Stimulation (VNS)

- Significant medical or psychiatric condition

- History of alcohol or drug abuse

- History of Ethosuximide use, Felbamate use after 1994 or Vigabatrin use after 1997

Detailed Description

The objective of this historical-controlled trial is to demonstrate the efficacy and safety of conversion to lacosamide monotherapy in subjects with partial-onset seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520741

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