Status:
COMPLETED
The Safety of Intravenous Lacosamide
Lead Sponsor:
Le Bonheur Children's Hospital
Conditions:
Epilepsy
Eligibility:
All Genders
4-35 years
Phase:
PHASE4
Brief Summary
To evaluate the safety of IV Lacosamide in children with partial-onset epilepsy, ages 4-35 years old, inclusive, who are either unable to take oral medication or require intravenous administration of ...
Detailed Description
Lacosamide tablets and intravenous formulations were both approved in the United States in the fall of 2008. Lacosamide is indicated for use as adjunctive therapy in the treatment of partial onset sei...
Eligibility Criteria
Inclusion
- Patients must have a diagnosis of epilepsy and have received anti-epileptic drug therapy prior to initiation of IV Lacosamide
- Patients must have a medical condition in which the parenteral administration of Lacosamide is desirable.
- Patients may be male or female.
- Patients must be 4 years of age or older, and less than age 35 years.
- Patient or his / her legally authorized representative must sign an informed consent form prior to any study specific procedures.
Exclusion
- Patients will be excluded from entry into the study if any of the following are true:
- Patient has previously participated in any other intravenous Lacosamide study.
- Patient has status epilepticus within the last 3 months.
- Patient has a history of drug allergy to Lacosamide.
- Patient is pregnant.
- Patient has taken experimental drug within last 30 days.
- Patient with significant hepatic or renal disease.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00832884
Start Date
March 1 2010
End Date
November 1 2012
Last Update
September 22 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
LeBonheur Children's Medical Center
Memphis, Tennessee, United States, 38103