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Lacosamid-i.v.-Register (LCM)

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ClinicalTrials.gov Identifier: NCT01620840
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
Ulrich Stephani, University of Schleswig-Holstein

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

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

Study Design
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Study Type : Observational
Actual Enrollment : 130 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Lacosamid-i.v.-Register
Study Start Date : June 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
Drug Information available for: Lacosamide
U.S. FDA Resources

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


Outcome Measures
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Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: June 15, 2012    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 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