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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00832884
Other study ID # 00570-FB
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 2010
Est. completion date November 2012

Study information

Verified date September 2020
Source Le Bonheur Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Other known NCT identifiers
  • NCT00720863

Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date November 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender All
Age group 4 Years to 35 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States LeBonheur Children's Medical Center Memphis Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Le Bonheur Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. Epub 2007 Sep 19. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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