Back to results

The Safety of Intravenous Lacosamide

Primary Purpose

Epilepsy

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Lacosamide

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring partial, onset, epilepsy, pediatric, lacosamide, partial onset epilepsy, vimpat

Eligibility Criteria

4 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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 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.

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.

Sites / Locations

LeBonheur Children's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Arm Label

Group 1A

Group 2A

Group 3A

Group 4A

Group 1B

Group 2B

Group 3B

Group 4B

Arm Description

Lacosamide, IV, 50 mg, once, 30 minutes

Lacosamide, IV, 100 mg, once, 30 min

Lacosamide, IV, 150 mg, once, 30 min

Lacosamide, IV, 200 mg, once, 30 min

Lacosamide, IV, 50 mg, once, 15 min

Lacosamide, IV, 100 mg, once, 15 min

Lacosamide, IV, 150 mg, once, 15 min

Lacosamide, IV, 200 mg, once, 15 min

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00832884

First Posted

January 29, 2009

Last Updated

September 21, 2020

Sponsor

Le Bonheur Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00832884

Brief Title

The Safety of Intravenous Lacosamide

Official Title

IV Lacosamide: The Safety of Intravenous Lacosamide

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Le Bonheur Children's Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy

Keywords

partial, onset, epilepsy, pediatric, lacosamide, partial onset epilepsy, vimpat

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1A

Arm Type

Active Comparator

Arm Description

Lacosamide, IV, 50 mg, once, 30 minutes

Arm Title

Group 2A

Arm Type

Active Comparator

Arm Description

Lacosamide, IV, 100 mg, once, 30 min

Arm Title

Group 3A

Arm Type

Active Comparator

Arm Description

Lacosamide, IV, 150 mg, once, 30 min

Arm Title

Group 4A

Arm Type

Active Comparator

Arm Description

Lacosamide, IV, 200 mg, once, 30 min

Arm Title

Group 1B

Arm Type

Active Comparator

Arm Description

Lacosamide, IV, 50 mg, once, 15 min

Arm Title

Group 2B

Arm Type

Active Comparator

Arm Description

Lacosamide, IV, 100 mg, once, 15 min

Arm Title

Group 3B

Arm Type

Active Comparator

Arm Description

Lacosamide, IV, 150 mg, once, 15 min

Arm Title

Group 4B

Arm Type

Active Comparator

Arm Description

Lacosamide, IV, 200 mg, once, 15 min

Intervention Type

Drug

Intervention Name(s)

Lacosamide

Other Intervention Name(s)

Vimpat

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility 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 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James W Wheless, MD

Organizational Affiliation

LeBonheur Children's Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

LeBonheur Children's Medical Center

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38103

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17888078

Citation

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.

Results Reference

result

PubMed Identifier

11137386

Citation

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.

Results Reference

result

Links:

URL

http://www.lebonheur.org

Description

Study site website

Learn more about this trial

The Safety of Intravenous Lacosamide

We'll reach out to this number within 24 hrs