NCT01620840

Lacosamid-i.v.-Register

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 130 (actual)
• Sponsor: University Hospital Schleswig-Holstein · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy With Partial Onset Seizures With or Without Secondary Generalization

Interventions

Type	Name	Description
DRUG	Lacosamide 10mg/ml	intravenous administration up to 10 days

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-06-15
• Last updated: 2015-05-28

Locations

1 site across 1 country: Germany