Lacosamid-i.v.-Register

NCT01620840 | Completed DMC

• 1 other identifier: UCB-LCM-2011
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

oral administration of Lacosamide is not possible or adequate

Study Arms (1)

Lacosamid-i.v. treatment

Drug: Lacosamide 10mg/ml

Interventions

Lacosamide 10mg/ml DRUG

intravenous administration up to 10 days

Also known as: VimpatⓇ

Lacosamid-i.v. treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are treated with Lacosamide i.v.-solution in routine clinical practice.

You may qualify if:

• 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

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Neurologie

Kiel, Schleswig-Holstein, 24105, Germany

Location

MeSH Terms

Interventions

Lacosamide

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Study Officials

• Ulrich Stephani, Prof.Dr.med.

  University hospital Schleswig-Holstein, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Ulrich Stephani

Study Record Dates

• First Submitted: June 13, 2012
• First Posted: June 15, 2012
• Study Start: June 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

DE (1)