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| Sponsor: | Thomas Jefferson University |
|---|---|
| Information provided by: | Thomas Jefferson University |
| ClinicalTrials.gov Identifier: | NCT00774306 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Subarachnoid Hemorrhage |
Drug: phenytoin Drug: valproate Drug: levetiracetam |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Pharmacodynamics Study |
| Official Title: | The Effects of Antiepileptic Drugs on Serum Lipids and Inflammation in Patients With Subarachnoid Hemorrhage |
| Estimated Enrollment: | 200 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.
|
Drug: phenytoin
Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.
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|
2: Active Comparator
Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.
|
Drug: valproate
Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.
|
|
3: Active Comparator
Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
|
Drug: levetiracetam
Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
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4: No Intervention
Participants randomized to Group 4 will receive no drug intervention.
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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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Prema Kishna, MD | 215-503-5646 | prema.krishna@jefferson.edu |
| Contact: Scott Mintzer, MD | 215-503-9831 | scott.mintzer@jefferson.edu |
| 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 prema.krishna@jefferson.edu | |
| Principal Investigator: Scott Mintzer, MD | |
| Principal Investigator: | Scott Mintzer, MD | Assistant Professor of Neurology, Jefferson Comprehensive Epilepsy Center |
More Information
| Responsible Party: | Thomas Jefferson University ( Scott Mintzer, MD, Assistant Professor of Neurology, Jefferson Comprehensive Epilepsy Center ) |
| Study ID Numbers: | K23NS058669, 1K23NS058669 |
| Study First Received: | October 16, 2008 |
| Last Updated: | September 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00774306 History of Changes |
| Health Authority: | United States: Federal Government |
|
vascular risk lipid fractions lipoprotein(a) C-reactive protein subarachnoid hemorrhage |
antiepileptic drug randomized seizure cholesterol |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Intracranial Hemorrhages Brain Diseases Hemorrhage Cerebrovascular Disorders Valproic Acid Phenytoin Pathologic Processes Therapeutic Uses Cardiovascular Diseases Nootropic Agents |
Tranquilizing Agents Nervous System Diseases Vascular Diseases Central Nervous System Diseases Central Nervous System Depressants Enzyme Inhibitors Antimanic Agents Pharmacologic Actions Subarachnoid Hemorrhage GABA Agents Etiracetam Central Nervous System Agents Anticonvulsants |