The Safety of Intravenous Lacosamide
This study is currently recruiting participants.
Verified February 2012 by Le Bonheur Children's Medical Center
Sponsor:
Le Bonheur Children's Medical Center
Information provided by (Responsible Party):
James W. Wheless, Le Bonheur Children's Medical Center
ClinicalTrials.gov Identifier:
NCT00832884
First received: January 29, 2009
Last updated: February 23, 2012
Last verified: February 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
To evaluate the safety of IV Lacosamide in children with partial-onset epilepsy, ages 4-20 years old, inclusive, who are either unable to take oral medication or require intravenous administration of IV Lacosamide.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy |
Drug: Lacosamide |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | IV Lacosamide: The Safety of Intravenous Lacosamide |
Resource links provided by NLM:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
MedlinePlus related topics:
Epilepsy
Drug Information available for:
Lacosamide
U.S. FDA Resources
Further study details as provided by Le Bonheur Children's Medical Center:
Primary Outcome Measures:
- 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: one year ] [ Designated as safety issue: Yes ]
- 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.
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Group 1A
Subjects 001, 002, 003, 004, 005
|
Drug: Lacosamide
0.7 mg/kg (up to maximum of 50 mg) x 5 subjects x 30 minutes
Other Name: Vimpat
|
|
Active Comparator: Group 2A
Subjects 006, 007, 008, 009, 010
|
Drug: Lacosamide
1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 30 minutes
Other Name: Vimpat
|
|
Active Comparator: Group 3A
Subjects 011, 012, 013, 014, 015
|
Drug: Lacosamide
2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 30 minutes
Other Name: Vimpat
|
|
Active Comparator: Group 4A
Subjects 016, 017, 018, 019, 020
|
Drug: Lacosamide
2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 30 minutes
Other Name: Vimpat
|
|
Active Comparator: Group 1B
Subjects 021, 022, 023, 024, 025
|
Drug: Lacosamide
0.7 mg/kg (up to a maximum of 50 mg) x 5 subjects x 15 minutes
Other Name: Vimpat
|
|
Active Comparator: Group 2B
Subjects 026, 027, 028, 029, 030
|
Drug: Lacosamide
1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 15 minutes
Other Name: Vimpat
|
|
Active Comparator: Group 3B
Subjects 031, 032, 033, 034, 035
|
Drug: Lacosamide
2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 15 minutes
Other Name: Vimpat
|
|
Active Comparator: Group 4B
Subjects 036, 037, 038, 039, 040
|
Drug: Lacosamide
2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 15 minutes
Other Name: Vimpat
|
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 20 years, who are either unable to take oral medication, or whom parenteral administration of IV Lacosamide is desirable.
Eligibility| Ages Eligible for Study: | 4 Years to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 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 20 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832884
Contacts
| Contact: Michelle J Ellis, RN, CCRP | 901-287-5330 | Michelle.Ellis@lebonheur.org |
Locations
| United States, Tennessee | |
| LeBonheur Children's Medical Center | Recruiting |
| Memphis, Tennessee, United States, 38103 | |
| Contact: Michelle J Ellis, RN 901-287-5330 Michelle.Ellis@lebonheur.org | |
| Sub-Investigator: Amy L McGregor, MD | |
| Sub-Investigator: Colin A Hovinga, PharmD | |
| Sub-Investigator: Thomas K Chin, MD | |
| Sub-Investigator: Kathryn C Van Poppel, MD | |
| Sub-Investigator: Stephen A Fulton, MD | |
Sponsors and Collaborators
Le Bonheur Children's Medical Center
Investigators
| Principal Investigator: | James W Wheless, MD | LeBonheur Children's Medical Center |
More Information
Additional Information:
Publications:
| Responsible Party: | James W. Wheless, Principal Investigator, Le Bonheur Children's Medical Center |
| ClinicalTrials.gov Identifier: | NCT00832884 History of Changes |
| Other Study ID Numbers: | 00570-FB |
| Study First Received: | January 29, 2009 |
| Last Updated: | February 23, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Le Bonheur Children's Medical Center:
|
partial onset epilepsy pediatric |
lacosamide partial onset epilepsy vimpat |
Additional relevant MeSH terms:
|
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013