IV Lacosamide: The Safety of Intravenous Lacosamide

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the safety of IV Lacosamide in children ages 4-35.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Safety of Intravenous Lacosamide

NCT00832884

Epilepsy

COMPLETED PHASE4

A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide

NCT01110187

Traumatic Brain Injury

TERMINATED NA

Lacosamide IV and EEG/EKG (LIVE) Study

NCT01724918

Focal Epilepsy

TERMINATED PHASE2

Intravenous Lacosamide Compared With Fosphenytoin in the Treatment of Patients With Frequent Nonconvulsive Seizures

NCT01458522

Nonconvulsive Seizures

COMPLETED PHASE2

eValuation of the Efficacy and toleRability of Vimpat When Added to lEvetiracetam

NCT01484977

Epilepsy

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The objective of this study is to evaluate the safety of IV Lacosamide in children ages 4 years to 35 years, inclusive who are unable to take oral medications or require parenteral administration of IV Lacosamide Occasionally, patients over the age of 20 are seen at LeBonheur Children's Hospital due to the complexity of their condition, or due to a long relationship with their physician. These are exceptions which are reviewed on a case by case basis and are approved by the hospital administrator for admissions and outpatient testing.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epilepsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

IV Lacosamide administered (intravenously) over 30 minutes: 0.7mg/kg, 1.4 mg/kg, 2.1 mg/ kg and 2.9 mg/kg over 30 minutes.

Group Type ACTIVE_COMPARATOR

IV Lacosamide

Intervention Type DRUG

Lacosamide administered intravenously over 15 or 30 minutes, depending on study arm, to patients with epilepsy.

Group B

IV Lacosamide to be administered (intravenously) over 15 minutes: 0.7mg/kg, 1.4 mg/kg, 2.1mg/kg, 2,4 mg/kg

Group Type ACTIVE_COMPARATOR

IV Lacosamide

Intervention Type DRUG

Lacosamide administered intravenously over 15 or 30 minutes, depending on study arm, to patients with epilepsy.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IV Lacosamide

Lacosamide administered intravenously over 15 or 30 minutes, depending on study arm, to patients with epilepsy.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Vimpat

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient or LAR must sign informed consent
* Diagnosis of partial onset currently uncontrolled
* Patient must have received anti-epileptic drug therapy prior to initiation
* Patient must have a medical condition in which parental administration is desireable
* Male or female
* Ages 4-35

Exclusion Criteria

* Patient has participated in a study involving IV Lacosamide
* Patient has had an episode of status epilepticus in the last 3 months
* Drug history to lacosamide pregnant or lactating
* If of child bearing age, must have pregnancy test
* Patient has participated in an experimental drug study in last 30 days
* Patients with significant active hepatic or renal disease.
* Patients with known cardiac disease.

Minimum Eligible Age

4 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes