Overview

Lacosamid-i.v.-Register

Status:
Completed
Trial end date:
2013-11-01
Target enrollment:
0
Participant gender:
All
Summary
Lacosamide is a new antiepileptic drug (AED) marketed as Vimpat with three different formulations, tablets, oral syrup and a solution for intravenous infusion. Lacosamide is approved as adjunctive therapy in epilepsy patients with partial onset seizures with or without secondary generalization. The i.v. solution is used in patients in which oral administration is not possible or adequate. Bioequivalence with oral tablets and safety could be demonstrated in healthy volunteers and in patients switched from tablets to Lacosamide i.v. solution. A recently published study demonstrates the feasibility of single loading doses up to 300 mg. The aim of this Lacosamide i.v. registry is to collect systematically data on the safety, tolerability and administration procedures when Lacosmide i.v. is used in routine daily clinical practice, mainly in hospitals. These data will help treating physicians to optimize the use of Lacosamide i.v. in clinical routine.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital Schleswig-Holstein
University of Schleswig-Holstein
Treatments:
Lacosamide
Criteria
Inclusion Criteria:

- before any data are collected for any patient in this registry an ehtical committee
must be notified of the registry and written data consent must be properly executed
and documented

Exclusion Criteria: