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

June 13, 2012
May 27, 2015
June 2011
November 2013   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01620840 on ClinicalTrials.gov Archive Site
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Lacosamid-i.v.-Register
Lacosamid-i.v.-Register

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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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

Epilepsy With Partial Onset Seizures With or Without Secondary Generalization
Drug: Lacosamide 10mg/ml
intravenous administration up to 10 days
Other Name: VimpatⓇ
Lacosamid-i.v. treatment
Intervention: Drug: Lacosamide 10mg/ml
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
November 2013
November 2013   (final data collection date for primary outcome measure)

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:

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01620840
UCB-LCM-2011
Yes
Ulrich Stephani, University of Schleswig-Holstein
University of Schleswig-Holstein
Not Provided
Principal Investigator: Ulrich Stephani, Prof.Dr.med. University hospital Schleswig-Holstein, Germany
University of Schleswig-Holstein
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP