Safety Study Of Intravenous Levetiracetam
This study has been completed.
Sponsor:
Le Bonheur Children's Medical Center
Information provided by (Responsible Party):
James W. Wheless, Le Bonheur Children's Medical Center
ClinicalTrials.gov Identifier:
NCT00720863
First received: July 21, 2008
Last updated: December 20, 2012
Last verified: December 2012
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Purpose
The test article for this study is levetiracetam (Keppra, which is commercially available. Keppra is indicated for use as adjunctive therapy in the treatment of partial onset seizure disorders in patients age four years and above. An intravenous dosage form of levetiracetam is available for patients who are unable to take the oral form. UCB has conducted pharmacokinetic studies in normal volunteers and one safety study in epileptic patients using IV levetiracetam. These studies have shown a 1:1 ratio between doses of oral and parental levetiracetam. In addition, several different infusion rates have been studied, from five minutes to fifteen minutes with no significant safety concerns. These studies were performed in adults age 16 and over. This was done because at the time when IV studies were conducted, there was no pediatric approval However, since then a pediatric indication has been approved, based on the results of a successful outpatient pediatric study in children ages four to sixteen years, using levetiracetam as adjunctive therapy for partial seizures.
| Condition | Intervention | Phase |
|---|---|---|
|
Seizures |
Drug: levetiracetam |
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: Prevention |
| Official Title: | The Safety of Intravenous Levetiracetam |
Resource links provided by NLM:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
Drug Information available for:
Levetiracetam
U.S. FDA Resources
Further study details as provided by Le Bonheur Children's Medical Center:
Primary Outcome Measures:
- To evaluate the study of IV levetiracetam in children/young adults with epilepsy ages 4 to 23,who are either unable to take oral medication, or in who iv administration is desirable. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Additionally, the investigators aim to collect safety information in a population of patients where IV levetiracetam may reasonably be expected to be used, (i.e., children over age four and less than age twenty-three. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 45 |
| Study Start Date: | February 2007 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Levetiracetam 20/mg/kg Maximum 1,000 mg
Levetiracetam 20mg/kg (maximum 1,000 mg)given IV over 5 minutes
|
Drug: levetiracetam
Intravenous, 20mg/kg,once, over 5 minutes
Other Names:
|
|
Active Comparator: Levetiracetam 40 mg/kg (maximum 2,000 mg) over 5 minutes
Levetiracetam 40mg/kg (maximum 2,000 mg)given IV over 5 minutes
|
Drug: levetiracetam
Intravenous, 40mg/kg,once, over 5 minutes
Other Names:
|
|
Active Comparator: Levetiracetam 60mg/kg (maximum 3,000 mg)
Levetiracetam 60mg/kg (maximum 3,000 mg)given over 6 minutes.
|
Drug: levetiracetam
Intravenous,60mg/kg,once, over 6 minutes
Other Names:
|
Detailed Description:
Each subject will receive open label levetiracetam.
Eligibility| Ages Eligible for Study: | 4 Years to 23 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects must have a confirmed diagnosis of either partial onset seizures or generalized epilepsy and have received anti-epileptic drug therapy prior to initiation of IV levetiracetam.
- Subjects must have a medical condition in which the rapid achievement of serum levels with the use parenteral administration of levetiracetam is desirable. Such as in the case of re-initiating drug therapy to achieve therapeutic serum levels of an inpatient prior to discharge.
- Subject may be male or female.
- Subject must be four years of age or older, and less than age 23 years. This age is indicative of the patient population typically treated at LeBonheur Children's Medical Center.
- Subject or his/her legally authorized representative must sign an informed consent prior to any study-specific procedures.
Exclusion Criteria:
- Subject has previously participated in any other intravenous levetiracetam study.
- Subject has status epilepticus within the last 6 months.
- Subject has a history of a drug allergy to levetiracetam.
- Subject is pregnant.
- Subject has taken an experimental drug within the last 30 days.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720863
Locations
| United States, Tennessee | |
| Lebonheur Children's Hospital | |
| Memphis, Tennessee, United States, 38103 | |
Sponsors and Collaborators
Le Bonheur Children's Medical Center
Investigators
| Principal Investigator: | James W Wheless, MD | University of Tennessee Healthscience Center Pediatric Neurology |
More Information
Additional Information:
Publications:
| Responsible Party: | James W. Wheless, Principal Investigator, Le Bonheur Children's Medical Center |
| ClinicalTrials.gov Identifier: | NCT00720863 History of Changes |
| Other Study ID Numbers: | MHIRB#2006-047 |
| Study First Received: | July 21, 2008 |
| Last Updated: | December 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Le Bonheur Children's Medical Center:
|
levetiracetam intravenous pediatric |
safety partial seizures |
Additional relevant MeSH terms:
|
Seizures Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Etiracetam Piracetam |
Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Nootropic Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013