Lacosamid-i.v.-Register (LCM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Schleswig-Holstein.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Ulrich Stephani, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01620840
First received: June 13, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  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:


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

Estimated Enrollment: 200
Study Start Date: June 2011
Estimated Study Completion Date: April 2013
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
Genders Eligible for Study:   Both
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

Contacts
Contact: Ulrich Stephani, Prof.Dr.med. +49 431 597 ext 1761 stephani@pedneuro.uni-kiel.de
Contact: Irene Lehmann +49 431 597 ext 1761 i.lehmann@pedneuro.uni-kiel.de

Locations
Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Neurologie Recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Contact: Nicolas Lang, Dr. med.    0049(0)431 597 ext 0      
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
Principal Investigator: Ulrich Stephani, Prof.Dr.med. University hospital Schleswig-Holstein, Germany
  More Information

No publications provided

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: June 13, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Schleswig-Holstein:
oral administration of Lacosamide is not possible or adequate

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Lacosamide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014