NCT00832884

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2009

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

2.2 years

First QC Date

January 29, 2009

Last Update Submit

September 21, 2020

Conditions

Epilepsy

Keywords

partialonsetepilepsypediatriclacosamidepartial onset epilepsyvimpat

Outcome Measures

Primary Outcomes (1)

  • To evaluate the safety of IV Lacosamide given as a rapid infusion.

    The safety of IV Lacosamide will be assessed in patients in whom parental administration of Lacosamide is warranted.

    one year

Study Arms (8)

Group 1A

ACTIVE COMPARATOR

Lacosamide, IV, 50 mg, once, 30 minutes

Drug: Lacosamide

Group 2A

ACTIVE COMPARATOR

Lacosamide, IV, 100 mg, once, 30 min

Drug: Lacosamide

Group 3A

ACTIVE COMPARATOR

Lacosamide, IV, 150 mg, once, 30 min

Drug: Lacosamide

Group 4A

ACTIVE COMPARATOR

Lacosamide, IV, 200 mg, once, 30 min

Drug: Lacosamide

Group 1B

ACTIVE COMPARATOR

Lacosamide, IV, 50 mg, once, 15 min

Drug: Lacosamide

Group 2B

ACTIVE COMPARATOR

Lacosamide, IV, 100 mg, once, 15 min

Drug: Lacosamide

Group 3B

ACTIVE COMPARATOR

Lacosamide, IV, 150 mg, once, 15 min

Drug: Lacosamide

Group 4B

ACTIVE COMPARATOR

Lacosamide, IV, 200 mg, once, 15 min

Drug: Lacosamide

Interventions

LacosamideDRUG

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

Also known as: Vimpat
Group 1AGroup 1BGroup 2AGroup 2BGroup 3AGroup 3BGroup 4AGroup 4B

Eligibility Criteria

Age4 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients must have a diagnosis of epilepsy and have received anti-epileptic drug therapy prior to initiation of IV Lacosamide
  • Patients must have a medical 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LeBonheur Children's Medical Center

Memphis, Tennessee, 38103, United States

Location

Related Publications (2)

  • Biton V, Rosenfeld WE, Whitesides J, Fountain NB, Vaiciene N, Rudd GD. Intravenous lacosamide as replacement for oral lacosamide in patients with partial-onset seizures. Epilepsia. 2008 Mar;49(3):418-24. doi: 10.1111/j.1528-1167.2007.01317.x. Epub 2007 Sep 19.

    PMID: 17888078RESULT

  • Bialer M, Johannessen SI, Kupferberg HJ, Levy RH, Loiseau P, Perucca E. Progress report on new antiepileptic drugs: a summary of the Fifth Eilat Conference (EILAT V). Epilepsy Res. 2001 Jan;43(1):11-58. doi: 10.1016/s0920-1211(00)00171-6.

    PMID: 11137386RESULT

Related Links

MeSH Terms

Conditions

Epilepsy

Interventions

Lacosamide

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic Acids

Study Officials

  • James W Wheless, MD

    LeBonheur Children's Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 29, 2009

First Posted

January 30, 2009

Study Start

March 1, 2010

Primary Completion

May 1, 2012

Study Completion

November 1, 2012

Last Updated

September 22, 2020

Record last verified: 2020-09

Locations

US(1)