Lacosamid-i.v.-Register (LCM)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ulrich Stephani, University of Schleswig-Holstein

ClinicalTrials.gov Identifier:

NCT01620840

First received: June 13, 2012

Last updated: May 27, 2015

Last verified: May 2015

History of Changes

Purpose

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.

Condition	Intervention
Epilepsy With Partial Onset Seizures With or Without Secondary Generalization	Drug: Lacosamide 10mg/ml


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Lacosamid-i.v.-Register

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Seizures

Drug Information available for: Lacosamide

U.S. FDA Resources

Further study details as provided by Ulrich Stephani, University of Schleswig-Holstein:


Enrollment:	130
Study Start Date:	June 2011
Study Completion Date:	November 2013
Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Lacosamid-i.v. treatment	Drug: Lacosamide 10mg/ml intravenous administration up to 10 days Other Name: VimpatⓇ

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

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:

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620840

Locations


Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Neurologie
Kiel, Schleswig-Holstein, Germany, 24105

Sponsors and Collaborators

University of Schleswig-Holstein

Investigators


Principal Investigator:	Ulrich Stephani, Prof.Dr.med.	University hospital Schleswig-Holstein, Germany

More Information


Responsible Party:	Ulrich Stephani, Prof. Dr. med. Ulrich Stephani, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:	NCT01620840 History of Changes
Other Study ID Numbers:	UCB-LCM-2011
Study First Received:	June 13, 2012
Last Updated:	May 27, 2015

Keywords provided by Ulrich Stephani, University of Schleswig-Holstein:


oral administration of Lacosamide is not possible or adequate

Additional relevant MeSH terms:


Seizures Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases	Neurologic Manifestations Signs and Symptoms Lacosamide Anticonvulsants

ClinicalTrials.gov processed this record on September 21, 2017

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