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

January 29, 2009
March 24, 2014
March 2010
May 2012   (final data collection date for primary outcome measure)
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.
To evaluate the safety of IV Lacosamide in children with epilepsy, ages 4-20 years who are unable to take oral medication or whom parenteral administration of IV Lacosamide is desirable. [ Time Frame: Baseline, 5 , 10, 30, 60, and 120 minutes ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00832884 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Safety of Intravenous Lacosamide
IV Lacosamide: The Safety of Intravenous Lacosamide

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Epilepsy
  • Drug: Lacosamide
    0.7 mg/kg (up to maximum of 50 mg) x 5 subjects x 30 minutes
    Other Name: Vimpat
  • Drug: Lacosamide
    1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 30 minutes
    Other Name: Vimpat
  • Drug: Lacosamide
    2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 30 minutes
    Other Name: Vimpat
  • Drug: Lacosamide
    2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 30 minutes
    Other Name: Vimpat
  • Drug: Lacosamide
    0.7 mg/kg (up to a maximum of 50 mg) x 5 subjects x 15 minutes
    Other Name: Vimpat
  • Drug: Lacosamide
    1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 15 minutes
    Other Name: Vimpat
  • Drug: Lacosamide
    2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 15 minutes
    Other Name: Vimpat
  • Drug: IV Lacosamide
    2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 15 minutes
    Other Name: Vimpat
  • Active Comparator: Group 1A
    Lacosamide, IV, 50 mg, once, 30 minutes
    Intervention: Drug: Lacosamide
  • Active Comparator: Group 2A
    Lacosamide, IV, 100 mg, once, 30 min
    Intervention: Drug: Lacosamide
  • Active Comparator: Group 3A
    Lacosamide, IV, 150 mg, once, 30 min
    Intervention: Drug: Lacosamide
  • Active Comparator: Group 4A
    Lacosamide, IV, 200 mg, once, 30 min
    Intervention: Drug: Lacosamide
  • Active Comparator: Group 1B
    Lacosamide, IV, 50 mg, once, 15 min
    Intervention: Drug: Lacosamide
  • Active Comparator: Group 2B
    Lacosamide, IV, 100 mg, once, 15 min
    Intervention: Drug: Lacosamide
  • Active Comparator: Group 3B
    Lacosamide, IV, 150 mg, once, 15 min
    Intervention: Drug: Lacosamide
  • Active Comparator: Group 4B
    Lacosamide, IV, 200 mg, once, 15 min
    Intervention: Drug: IV Lacosamide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
November 2012
May 2012   (final data collection date for primary outcome measure)

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.
Both
4 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00832884
00570-FB
Yes
James W. Wheless, Le Bonheur Children's Hospital
Le Bonheur Children's Hospital
Not Provided
Principal Investigator: James W Wheless, MD LeBonheur Children's Medical Center
Le Bonheur Children's Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP