Lacosamid-i.v.-Register (LCM)
Recruitment status was Recruiting
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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 |
| 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 |
Patients who are treated with Lacosamide i.v.-solution in routine clinical practice.
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01620840
| 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 |
| 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 | |
| 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:
|
Lacosamide Anticonvulsants Central Nervous System Agents Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on February 25, 2015