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Corticosteroid
Interventional start for Epilepsy
Phase 1 & 2
Waitlist Available
Led By Jeremy Toler, MD
Research Sponsored by Louisiana State University Health Sciences Center in New Orleans
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the number of seizures per month will be assessed at 1 month (following placebo/intervention), 2 months (following wash-out period), and 3 months (following cross-over phase of placebo/intervention).
Awards & highlights
Summary
This trial is testing whether or not oral steroids can help reduce seizure frequency in children.
Eligible Conditions
- Epilepsy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the number of seizures per month will be assessed at 1 month (following placebo/intervention), 2 months (following wash-out), and 3 months (following cross-over phase of placebo/intervention). change compared to baseline will be calculated.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the number of seizures per month will be assessed at 1 month (following placebo/intervention), 2 months (following wash-out), and 3 months (following cross-over phase of placebo/intervention). change compared to baseline will be calculated.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Seizure frequency
Secondary study objectives
Adverse events
Drop out percentage
Seizure freedom
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Interventional startExperimental Treatment2 Interventions
Patients who randomize to the interventional start arm will receive the study drug, methylprednisolone sodium succinate, in the first month of the study, followed by placebo in the cross-over phase of the study.
Group II: Placebo startPlacebo Group2 Interventions
Patients who randomize to the placebo start arm will receive placebo in the first month of the study, followed by the study drug, methylprednisolone sodium succinate, in the cross-over phase of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylprednisolone hemisuccinate
FDA approved
Find a Location
Who is running the clinical trial?
Louisiana State University Health Sciences Center in New OrleansLead Sponsor
119 Previous Clinical Trials
44,818 Total Patients Enrolled
Jeremy Toler, MDPrincipal InvestigatorLouisiana State University Health Sciences Center
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