Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the trial is to evaluate the safety of intravenous (iv) lacosamide delivered in a single dose followed by 6.5 days of oral lacosamide treatment in subjects with partial-onset seizures.

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

Details

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

Criteria

Inclusion Criteria:

• Diagnosis of epilepsy with simple partial seizures and/or complex partial seizures

• Stable dose regimen of 1 to 2 marketed antiepileptic drug(s) (AED(s)) for 28 days prior to screening and duration of trial

• Acceptable candidate for venipuncture and intravenous (iv) infusion

• At least 1 partial seizure with motor component per 90 days

• Maximum allowed seizure frequency during 28 days prior to screening is 40 partial seizures of any type

Exclusion Criteria:

• Previous use of lacosamide

• History of primary generalized seizures

• History of status epilepticus within last 12 months

• History of cluster seizures during 8 week period prior to screening

• Non-epileptic events, including psychogenic seizures that could be confused with seizures

• Use of neuroleptics, monoamine oxidase (MAO) inhibitors, barbiturates, or narcotic analgesics within 28 days prior to screening

• Received any rescue benzodiazepines more than once during the 28 days prior to screening

• Concomitant treatment of felbamate or previous felbamate therapy within last 6 months

• Prior or concomitant vigabatrin use