Subarachnoid HemorrhageNCT00774306
Antiepileptic Drugs and Vascular Risk Markers
A study testing phenytoin, valproate and levetiracetam in people with Subarachnoid Hemorrhage, run by Thomas Jefferson University.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Subarachnoid Hemorrhage
- What is being tested?
- phenytoin, valproate and levetiracetam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Acute subarachnoid hemorrhage, Hunt-Hess Grades I-IV
- Within 48 hours of admission
Who cannot join
- Grade V subarachnoid hemorrhage
- 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)
About this study
Official title: The Effects of Antiepileptic Drugs on Serum Lipids and Inflammation in Patients With Subarachnoid Hemorrhage
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.
Read the detailed description
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.
- Conditions
- Subarachnoid Hemorrhage
- Being tested
- phenytoin, valproate, levetiracetam
- Keywords
- vascular risk, lipid fractions, lipoprotein(a), C-reactive protein, subarachnoid hemorrhage, antiepileptic drug, randomized, seizure, cholesterol
- Medical subject headings
- Subarachnoid Hemorrhage, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phenytoinDrug
Also called Dilantin, Cerebyx (a phenytoin pro-drug)
Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.
valproateDrug
Also called Depakote, Depacon
Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.
levetiracetamDrug
Also called Keppra
Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. Receives: Drug: phenytoin |
| 2 | Active comparator | 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. Receives: Drug: valproate |
| 3 | Active comparator | Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses. Receives: Drug: levetiracetam |
| 4 | No intervention | Participants randomized to Group 4 will receive no drug intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks, 16 weeks
Secondary outcomes (1)
Incidence of Acute Seizures, Incidence of Late Seizures, Overall Neurologic Function (as Measured by Modified Rankin Scale Scores)
Measured: 8 weeks, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startApr 2009
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: study no longer consistent with current clinical practice
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Mintzer, MD, Principal investigator, Assistant Professor of Neurology, Jefferson Comprehensive Epilepsy Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774306
- Sponsor's protocol ID
- K23NS058669
- Other IDs
- 1K23NS058669
- Status last verified
- Dec 2017
- First submitted
- 16 Oct 2008
- Last updated
- 18 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Antiepileptic Drugs on Serum Lipids and Inflammation in Patients With Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT00774306
- Acronym / sponsor ID
- K23NS058669
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- vascular risk, lipid fractions, lipoprotein(a), C-reactive protein, subarachnoid hemorrhage, antiepileptic drug, randomized, seizure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study no longer consistent with current clinical practice
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Apr 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 17 Oct 2008 (estimated)
- Results
- Posted 25 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: phenytoinParticipants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. |
| 2 | Active comparator | Drug: valproateParticipants 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. |
| 3 | Active comparator | Drug: levetiracetamParticipants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses. |
| 4 | No intervention | –Participants randomized to Group 4 will receive no drug intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Acute subarachnoid hemorrhage, Hunt-Hess Grades I-IV
- Within 48 hours of admission
Key exclusion criteria (4 listed)
- Grade V subarachnoid hemorrhage
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phenytoinAlso: Dilantin, Cerebyx (a phenytoin pro-drug)Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. | Drug | 1 |
| valproateAlso: Depakote, DepaconValproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses. | Drug | 2 |
| levetiracetamAlso: KeppraLevetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses. | Drug | 3 |
Primary outcome
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
1 secondary outcome
Incidence of Acute Seizures, Incidence of Late Seizures, Overall Neurologic Function (as Measured by Modified Rankin Scale Scores)
Time frame: 8 weeks, 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Mintzer, MD principal investigator
Assistant Professor of Neurology, Jefferson Comprehensive Epilepsy Center
Questions about this trial
What is this clinical trial studying?
A study testing phenytoin, valproate and levetiracetam in people with Subarachnoid Hemorrhage, run by Thomas Jefferson University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2017.