Lacosamid-i.v.-Register

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-11-30

Brief Summary

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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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Detailed Description

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Conditions

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Epilepsy With Partial Onset Seizures With or Without Secondary Generalization

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Lacosamid-i.v. treatment

Lacosamide 10mg/ml

Intervention Type DRUG

intravenous administration up to 10 days

Interventions

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Lacosamide 10mg/ml

intravenous administration up to 10 days

Intervention Type DRUG

Other Intervention Names

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VimpatⓇ

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No