Study Results
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View full resultsBasic Information
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TERMINATED
NA
52 participants
INTERVENTIONAL
2009-04-30
2012-06-30
Brief Summary
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Detailed Description
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This study is intended to find out if certain seizure medications raise levels of cholesterol and other blood components which could lead to an increased risk of heart attacks and strokes.
In this study, 200 people with acute subarachnoid hemorrhage will be randomized to treatment with one of three different seizure medicines-phenytoin, valproate, or levetiracetam-or to receive no seizure medication at all. In each participant, cholesterol and other blood markers that relate to heart attack and stroke risk will be measured shortly after hospital admission and again 8 weeks later. At the 8-week point most participants will have their seizure medication discontinued, and the same blood tests will be repeated.
Information from this study could lead to changes in how seizure medications are prescribed both in the subarachnoid hemorrhage population and in other people who are prone to seizures.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.
phenytoin
Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.
2
Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.
valproate
Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.
3
Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
levetiracetam
Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
4
Participants randomized to Group 4 will receive no drug intervention.
No interventions assigned to this group
Interventions
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phenytoin
Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.
valproate
Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.
levetiracetam
Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Within 48 hours of admission
Exclusion Criteria
* Being treated with a lipid-lowering agent
* Contraindication to phenytoin, valproate, or levetiracetam (e.g. history of allergy to one of these agents)
* Contraindication to receiving no antiepileptic drug treatment (e.g. history of pre-existing epilepsy, seizure activity on admission EEG)
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Thomas Jefferson University
OTHER
Responsible Party
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Principal Investigators
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Scott Mintzer, MD
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor of Neurology, Jefferson Comprehensive Epilepsy Center
Other Identifiers
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