Antiepileptic Drugs and Vascular Risk Markers
The purpose of this study is to determine if certain seizure medications raise levels of cholesterol and other blood components which could increase the risk of heart attacks and strokes.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effects of Antiepileptic Drugs on Serum Lipids and Inflammation in Patients With Subarachnoid Hemorrhage|
- Change in serum cholesterol, non-HDL cholesterol, HDL cholesterol, lipoprotein(a), and C-reactive protein from baseline to second draw and third draw in each of the 4 study arms [ Time Frame: 8 weeks, 16 weeks ] [ Designated as safety issue: No ]
- Incidence of acute seizures, incidence of late seizures, overall neurologic function (as measured by modified Rankin scale scores) [ Time Frame: 8 weeks, 16 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||November 2013|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.
Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.
Other Name: Dilantin, Cerebyx (a phenytoin pro-drug)
Active Comparator: 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 is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.
Other Name: Depakote, Depacon
Active Comparator: 3
Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
Other Name: Keppra
No Intervention: 4
Participants randomized to Group 4 will receive no drug intervention.
There is some evidence that certain seizure medicines may raise levels of cholesterol and other blood components which could increase the risk of heart attacks and strokes, however, more research is needed. Individuals with acute subarachnoid hemorrhage traditionally are treated with seizure medicines, but it is not clear which one is best, or if any such medication is necessary at all.
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.
|Contact: Prema Kishna, MDfirstname.lastname@example.org|
|Contact: Scott Mintzer, MDemail@example.com|
|United States, Pennsylvania|
|Jefferson Comprehensive Epilepsy Center, Thomas Jefferson University, 900 Walnut Street, Suite 200||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Prema Kishna, MD 215-503-5646 firstname.lastname@example.org|
|Principal Investigator: Scott Mintzer, MD|
|Principal Investigator:||Scott Mintzer, MD||Assistant Professor of Neurology, Jefferson Comprehensive Epilepsy Center|