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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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the efficacy and safety of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB BIOSCIENCES, Inc.
• Treatments: Lacosamide

Criteria

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