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

Completed · Phase 3

Conditions studied: Partial Epilepsies, Partial Onset Seizures

In brief

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.

Key facts

Study ID

NCT00655551

Run by

UCB BIOSCIENCES, Inc.

People needed

100

Starts

2008-04-01

Expected to finish

2009-09-01

Last updated by the study team

2018-07-17

Who can join

Age: 16 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Baltimore, Maryland, United States
• Study site — Chesterfield, Missouri, United States
• Study site — Columbus, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Dallas, Texas, United States
• Study site — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.