The Safety of Intravenous Lacosamide

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
James W. Wheless, Le Bonheur Children's Hospital
ClinicalTrials.gov Identifier:
NCT00832884
First received: January 29, 2009
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Epilepsy
Drug: Lacosamide
Drug: IV Lacosamide
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: IV Lacosamide: The Safety of Intravenous Lacosamide

Resource links provided by NLM:


Further study details as provided by Le Bonheur Children's Hospital:

Primary Outcome Measures:
  • To evaluate the safety of IV Lacosamide given as a rapid infusion. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    The safety of IV Lacosamide will be assessed in patients in whom parental administration of Lacosamide is warranted.


Enrollment: 40
Study Start Date: March 2010
Study Completion Date: November 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1A
Lacosamide, IV, 50 mg, once, 30 minutes
Drug: Lacosamide
0.7 mg/kg (up to maximum of 50 mg) x 5 subjects x 30 minutes
Other Name: Vimpat
Active Comparator: Group 2A
Lacosamide, IV, 100 mg, once, 30 min
Drug: Lacosamide
1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 30 minutes
Other Name: Vimpat
Active Comparator: Group 3A
Lacosamide, IV, 150 mg, once, 30 min
Drug: Lacosamide
2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 30 minutes
Other Name: Vimpat
Active Comparator: Group 4A
Lacosamide, IV, 200 mg, once, 30 min
Drug: Lacosamide
2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 30 minutes
Other Name: Vimpat
Active Comparator: Group 1B
Lacosamide, IV, 50 mg, once, 15 min
Drug: Lacosamide
0.7 mg/kg (up to a maximum of 50 mg) x 5 subjects x 15 minutes
Other Name: Vimpat
Active Comparator: Group 2B
Lacosamide, IV, 100 mg, once, 15 min
Drug: Lacosamide
1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 15 minutes
Other Name: Vimpat
Active Comparator: Group 3B
Lacosamide, IV, 150 mg, once, 15 min
Drug: Lacosamide
2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 15 minutes
Other Name: Vimpat
Active Comparator: Group 4B
Lacosamide, IV, 200 mg, once, 15 min
Drug: IV Lacosamide
2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 15 minutes
Other Name: Vimpat

Detailed Description:

Lacosamide tablets and intravenous formulations were both approved in the United States in the fall of 2008. Lacosamide is indicated for use as adjunctive therapy in the treatment of partial onset seizure disorder in patients' age seventeen years and older. A parenteral dosage form of Lacosamide is desirable for patients who are temporarily unable to take medication orally. The objective of this study is to evaluate the safety of IV Lacosamide in children with epilepsy, ages 4 to 35 years, who are either unable to take oral medication, or whom parenteral administration of IV Lacosamide is desirable.

  Eligibility

Ages Eligible for Study:   4 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Patients must have a diagnosis of epilepsy and have received anti-epileptic drug therapy prior to initiation of IV Lacosamide
  • Patients must have a medial condition in which the parenteral administration of Lacosamide is desirable.
  • Patients may be male or female.
  • Patients must be 4 years of age or older, and less than age 35 years.
  • Patient or his / her legally authorized representative must sign an informed consent form prior to any study specific procedures.

Exclusion Criteria

  • Patients will be excluded from entry into the study if any of the following are true:
  • Patient has previously participated in any other intravenous Lacosamide study.
  • Patient has status epilepticus within the last 3 months.
  • Patient has a history of drug allergy to Lacosamide.
  • Patient is pregnant.
  • Patient has taken experimental drug within last 30 days.
  • Patient with significant hepatic or renal disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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: NCT00832884

Locations
United States, Tennessee
LeBonheur Children's Medical Center
Memphis, Tennessee, United States, 38103
Sponsors and Collaborators
Le Bonheur Children's Hospital
Investigators
Principal Investigator: James W Wheless, MD LeBonheur Children's Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: James W. Wheless, Principal Investigator, Le Bonheur Children's Hospital
ClinicalTrials.gov Identifier: NCT00832884     History of Changes
Obsolete Identifiers: NCT00720863
Other Study ID Numbers: 00570-FB
Study First Received: January 29, 2009
Last Updated: March 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Le Bonheur Children's Hospital:
partial
onset
epilepsy
pediatric
lacosamide
partial onset epilepsy
vimpat

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 28, 2014