Status:
COMPLETED
Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures
Lead Sponsor:
UCB BIOSCIENCES, Inc.
Conditions:
Partial Epilepsies
Partial Onset Seizures
Eligibility:
All Genders
16-60 years
Phase:
PHASE3
Brief 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.
Detailed Description
This multicenter, open-label trial examined safety and tolerability of rapid initiation of adjunctive lacosamide via a single intravenous loading dose followed by oral maintenance treatment in subject...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00655551
Start Date
April 1 2008
End Date
September 1 2009
Last Update
July 17 2018
Active Locations (7)
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1
Phoenix, Arizona, United States
2
Baltimore, Maryland, United States
3
Chesterfield, Missouri, United States
4
Columbus, Ohio, United States