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Anti-epileptic drug
Seizure Prophylaxis for Seizures
Phase 4
Waitlist Available
Led By Richard Gonzalez, MD
Research Sponsored by Loyola University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients who have suffered intracranial injury identified by CT Scan
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
Study Summary
This trial will test whether anti-seizure medication can prevent seizures in brain injury patients and improve outcomes.
Eligible Conditions
- Seizures
- Traumatic Brain Injury
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Seizures (count of seizures)
Secondary outcome measures
Mortality
Side effects data
From 2006 Phase 4 trial • 251 Patients • NCT0016065430%
Somnolence
14%
Dizziness
6%
Fatigue
6%
Nausea
6%
Headache
6%
Sedation
2%
Convulsion
1%
Grand mal convulsion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Levetiracetam
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Seizure ProphylaxisExperimental Treatment1 Intervention
Participants randomized to this arm will receive the anti-seizure prophylaxis drug Levetiracetam for seven days post traumatic brain injury.
Group II: No seizure prophylaxisActive Control1 Intervention
Participants randomized to this arm will not receive anti-seizure prophylaxis
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Levetiracetam
FDA approved
Find a Location
Who is running the clinical trial?
Loyola UniversityLead Sponsor
156 Previous Clinical Trials
29,122 Total Patients Enrolled
Richard Gonzalez, MDPrincipal InvestigatorLoyola University
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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