Antiepileptic Drugs and Vascular Risk Markers

NCT00774306 | Terminated Results

• 2 other identifiers: K23NS0586691K23NS058669
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Subarachnoid Hemorrhage

Keywords

vascular risk; lipid fractions; lipoprotein(a); C-reactive protein; subarachnoid hemorrhage; antiepileptic drug; randomized; seizure; cholesterol

Outcome Measures

Primary Outcomes (1)

• 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

  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)

  8 weeks, 16 weeks

Study Arms (4)

1

ACTIVE COMPARATOR

Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.

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.

Drug: valproate

3

ACTIVE COMPARATOR

Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.

Drug: levetiracetam

4

NO INTERVENTION

Participants randomized to Group 4 will receive no drug intervention.

Interventions

phenytoin DRUG

Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.

Also known as: Dilantin, Cerebyx (a phenytoin pro-drug)

1

valproate DRUG

Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.

Also known as: Depakote, Depacon

2

levetiracetam DRUG

Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.

Also known as: Keppra

3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute subarachnoid hemorrhage, Hunt-Hess Grades I-IV
• Within 48 hours of admission

You may not qualify if:

• 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)

Sponsors & Collaborators

• Thomas Jefferson University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Seizures

Interventions

Phenytoin; fosphenytoin; Valproic Acid; Levetiracetam

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydantoins; Imidazolidines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Acetamides; Amides; Acetates; Pyrrolidinones; Pyrrolidines

Limitations and Caveats

Study terminated due to 1) change in clinical practice; 2) inadequate recruitment and follow-up. Number of pts providing full data was \<15% of goal. Because of this, any analysis of data was considered futile, and no analyses were performed.

Results Point of Contact

• Title: Dr. Scott Mintzer
• Organization: Thomas Jefferson University

scott.mintzer@jefferson.edu

215-955-1222

Study Officials

• Scott Mintzer, MD

  Assistant Professor of Neurology, Jefferson Comprehensive Epilepsy Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 17, 2008
• Study Start: April 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 18, 2017
• Results First Posted: November 25, 2014

Record last verified: 2017-12