Epilepsy Clinical Trial
Official title:
IV Lacosamide: The Safety of Intravenous Lacosamide
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 |
Verified date | September 2020 |
Source | Le Bonheur Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | LeBonheur Children's Medical Center | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Le Bonheur Children's Hospital |
United States,
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
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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