Lacosamid-i.v.-Register (LCM)
This study has been completed.
Sponsor:
University of Schleswig-Holstein
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
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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
Drug Information available for:
Lacosamide
U.S. FDA Resources
Further study details as provided by 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) |
| 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
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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
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 |
| 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 |
ClinicalTrials.gov processed this record on September 26, 2016