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Levetiracetam to Prevent Post-Traumatic Epilepsy

Information source: Children's Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy; Post-traumatic Epilepsy

Intervention: Levetiracetam (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Children's Research Institute

Official(s) and/or principal investigator(s):
Pavel Klein, M.D., Principal Investigator, Affiliation: Children's Research Institute


Head injury is the cause of approximately 5% of all epilepsy in the US. Past attempts at preventing epilepsy by treatment with older antiepileptic drugs have been unsuccessful. Levetiracetam is a novel AED with potent antiepileptogenic properties in animal models of epilepsy. It has a favorable side effect and pharmacokinetic profile. It is therefore a strong candidate for a clinical trial of epilepsy prevention following traumatic brain injury (TBI). However, there has been no experience in administering levetiracetam rapidly to individuals with acute TBI. The investigators propose to initiate the evaluation of levetiracetam in prevention of post-traumatic epilepsy by determining the safety, tolerability, pharmacokinetics and feasibility of acute and chronic administration of levetiracetam to individuals with head injury with a high risk for developing post-traumatic epilepsy. Further, the investigators will follow subjects for 2 years after injury in order to obtain pilot data about effect of levetiracetam on PTE. This pilot study is the first step in evaluation of levetiracetam in prevention of post-traumatic epilepsy.

Clinical Details

Official title: Pilot: Levetiracetam to Prevent Post-Traumatic Epilepsy

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

adverse effect profile

pharmacokinetic profile of levetiracetam

pharmacokinetic profile of levetiracetam administered during the acute and chronic phase of head injury orally, intravenously and via orogastric tube

Secondary outcome:

Subject enrollment

Subject retention

Treatment compliance

post-traumatic epilepsy


Minimum age: 6 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Acute head injury associated with one of the following:

Intracranial hemorrhage, including epidural, subdural and intracerebral hemorrhage or with cerebral contusion(s) of any size; Penetrating (foreign body) head injury; Skull fracture and dural tear; Seizure within 8 hours of head injury

- Onset of head injury within 8-hours of proposed treatment initiation.

- Glasgow Coma Scale 6-15.

- Male and female subjects aged ≥ 6 years.

Exclusion Criteria:

- Clinical contraindications:

- Previous epilepsy or status epilepticus.

- Any systemic illness or unstable medical condition that might pose additional

risk, including: renal insufficiency, other unstable metabolic or endocrine disturbances, and active systemic cancer.

- Psychosis within six months of enrollment as determined by history of

hospitalization for psychosis or medications for psychosis.

- Moderate to severe mental retardation (IQ< 55 or>2 school grade levels below the

expected for age [expected age = grade level +5]).

- Clinical/Laboratory Indicators:

- Serum creatinine > 1. 5 on the day of treatment initiation for adults.

- Serum creatinine ≥1. 5 for subjects ≥17 years old, ≥1. 0 for subjects 13-17 years

old and ≥0. 7 for subjects 6-12 years old.

- Pregnancy

- Use of any CNS-active investigational drugs within 3 months of enrollment.

- Use of Antiepileptic Drugs (AEDs) within two months of enrollment, for any


- Allergy/sensitivity to study drugs or their formulations:

- Active drug or alcohol dependence that, in the opinion of the site investigator,

would interfere with adherence to study requirements:

- Inability or unwillingness of subject or legal guardian/representative to give

written informed consent.

Locations and Contacts

Children's National Medical Center, Washington, District of Columbia 20010, United States

MedStar Research Institute, Washington, District of Columbia 20010, United States

Additional Information

Starting date: April 2005
Last updated: October 28, 2011

Page last updated: August 23, 2015

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