Status:
COMPLETED
Levetiracetam to Prevent Post-Traumatic Epilepsy
Lead Sponsor:
Pavel Klein
Collaborating Sponsors:
Medstar Health Research Institute
Conditions:
Epilepsy
Post-traumatic Epilepsy
Eligibility:
All Genders
6+ years
Phase:
PHASE2
Brief Summary
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 nove...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT01463033
Start Date
April 1 2005
End Date
February 1 2010
Last Update
January 13 2016
Active Locations (2)
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1
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
2
MedStar Research Institute
Washington D.C., District of Columbia, United States, 20010