Lacosamid-i.v.-Register (LCM)

University Hospital Schleswig-Holstein (UKSH)

Status: Completed

Conditions: Epilepsy With Partial Onset Seizures With or Without Secondary Generalization

Treatments: Drug: Lacosamide 10mg/ml

Study type: Observational

Funder types: Other

Identifiers

NCT01620840

UCB-LCM-2011

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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:

Trial design

130 participants in 1 patient group

Lacosamid-i.v. treatment

Treatment:

Drug: Lacosamide 10mg/ml