Levetiracetam to Prevent Post-Traumatic Epilepsy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2010-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Epilepsy Post-traumatic Epilepsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Levetiracetam

66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy will receive levetiracetam 55 mg/kg/day in a b.i.d. schedule. Treatment will commence within 8 hours of the acute head injury and will last for 30 days. In addition, subjects will receive phenytoin for 1 week following head injury as standard clinical care.

Group Type ACTIVE_COMPARATOR

Levetiracetam

Intervention Type DRUG

55 mg/kg/day given in 2 divided doses 12 hours apart

No Intervention Control

60 subjects with acute head injury with a high risk for developing post-traumatic epilepsy enrolled 8-24 hours after injury will not receive levetiracetam. Subjects will receive phenytoin for 1 week following head injury as standard clinical care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Levetiracetam

55 mg/kg/day given in 2 divided doses 12 hours apart

Intervention Type DRUG

Other Intervention Names

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Keppra (brand name)

Eligibility Criteria

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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.

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 indication.
* 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.

Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No