← Back to Search

Age-Based Seizure Protocol for Pediatric Seizures (PediDOSE Trial)

Phase 3
Recruiting
Led By Manish I Shah, MD, MS
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between paramedic midazolam administration and hospital discharge, assessed up to 24 hours
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is designed to improve how paramedics treat seizures in children by making the midazolam dose age-based.

Who is the study for?
The PediDOSE trial is for children actively seizing when paramedics arrive, under their care, and transported by an EMS agency in the study. It excludes kids with known pregnancy, benzodiazepine allergy, or severe growth restriction as judged by the paramedic.
What is being tested?
PediDOSE tests if age-based doses of midazolam given via muscle injection or nasal spray are more effective than current calculation-based methods at stopping seizures before reaching the hospital. The study changes protocols across 20 cities to compare outcomes.
What are the potential side effects?
Potential side effects may include difficulty breathing if too much midazolam is administered. However, standardized doses used in this trial have been safely applied in other healthcare settings for children.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between paramedic arrival on scene until 30 minutes after emergency department arrival
This trial's timeline: 3 weeks for screening, Varies for treatment, and between paramedic arrival on scene until 30 minutes after emergency department arrival for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Seizing on emergency department arrival
Secondary study objectives
Respiratory failure
Time to first midazolam administration
Other study objectives
Depressed level of consciousness
Dose/route adherence
Life-threatening cardiac arrhythmia
+2 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
This arm will be exposed to the study intervention: a standardized seizure protocol.
Group II: ControlActive Control1 Intervention
This arm will be exposed to the emergency medical services (EMS) agency's existing seizure protocol; this is the control arm

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,485 Previous Clinical Trials
17,511,333 Total Patients Enrolled
7 Trials studying Seizures
5,358 Patients Enrolled for Seizures
Baylor College of MedicineOTHER
1,026 Previous Clinical Trials
6,023,819 Total Patients Enrolled
3 Trials studying Seizures
777 Patients Enrolled for Seizures
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,382 Previous Clinical Trials
646,351 Total Patients Enrolled
38 Trials studying Seizures
9,533 Patients Enrolled for Seizures

Media Library

Conventional seizure protocol Clinical Trial Eligibility Overview. Trial Name: NCT05121324 — Phase 3
Conventional seizure protocol 2023 Treatment Timeline for Medical Study. Trial Name: NCT05121324 — Phase 3
~2426 spots leftby Jul 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top