Phase 4 N=52 Randomized Single-blind Treatment

Assess Safety and Efficacy of Levetiracetam(LEV;Keppra)for Seizure Prevention

Traumatic Brain Injury · Subarachnoid Hemorrhage

Bottom Line

View on ClinicalTrials.gov: NCT00618436 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2014

Primary outcome: Primary: Seizure Incidence — 5; 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Levetiracetam (Drug); Phenytoin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Cincinnati
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Seizure Incidence	5; 3	—
SECONDARY Extended Glasgow Outcome Score	2; 2; 3; 3; 3; 3	—
SECONDARY Disability Rating Scale (DRS)	24; 23; 15; 13; 17; 9	—
SECONDARY Incidence of Adverse Events	—	—

Summary

To show that the use of intravenous levetiracetam(LEV;Keppra)for seizure prevention in patients in the Neuroscience Intensive Care Unit will result in fewer side effects compared to the current standard of care anticonvulsant and will be at least as effective as the current standard of care in preventing clinical and sub-clinical seizure activity.

Eligibility Criteria

Inclusion Criteria

Subjects with traumatic brain injury
Glasgow Coma Score (GCS) score 3-8(inclusive), or GCS motor score of 5 or less and abnormal admission CT scan showing intracranial pathology
Hemodynamically stable with a systolic BP >90 mm Hg
At least one reactive pupil
A negative pregnancy test in females
Age at least 18 years
Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for research form OR
Subjects with subarachnoid hemorrhage (SAH)
SAH documented by CT scan
Hunt-Hess grade 3-5, inclusive
Hemodynamically stable with a systolic BP> 90 mm Hg
At least one reactive pupil
A negative pregnancy test in females
Age of at least 18 years
Signed informed consent and HIPAA authorization for research form

Exclusion Criteria for enrollment

No venous access
Spinal cord injury
History of or CT confirmation of previous brain injury such as brain tumor, cerebral infarct, or spontaneous intracerebral hemorrhage
Hemodynamically unstable
Suspected anoxic events
Other peripheral trauma likely to result in liver failure
Positive pregnancy test in females
Age less than 18 years of age
Known hypersensitivity to any anticonvulsant
An injury that, in the opinion of the principal investigator, has a high likelihood of death within the first 72 hours.
Any treatment, condition, or injury that contraindicates treatment with LEV (levetiracetam) or phenytoin (PHT).
Inability to obtain signed informed consent or HIPAA authorization for research.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00618436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.