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The Safety of Intravenous Lacosamide

NCT00832884 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-09-22

No results posted yet for this study

Summary

To evaluate the safety of IV Lacosamide in children with partial-onset epilepsy, ages 4-35 years old, inclusive, who are either unable to take oral medication or require intravenous administration of IV Lacosamide.

Conditions

Interventions

DRUG

Lacosamide

0.7 mg/kg (up to maximum of 50 mg) x 5 subjects x 30 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 30 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 30 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 30 minutes. 0.7 mg/kg (up to a maximum of 50 mg) x 5 subjects x 15 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 15 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 15 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 15 minutes

Sponsors & Collaborators

  • Le Bonheur Children's Hospital

    lead OTHER

Principal Investigators

  • James W Wheless, MD · LeBonheur Children's Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-05-31
Completion
2012-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00832884 on ClinicalTrials.gov