SeizuresPhase 3PediDOSENCT05121324
Pediatric Dose Optimization for Seizures in Emergency Medical Services
A Phase 3 study testing Standardized seizure protocol and Conventional seizure protocol in people with Seizures, run by Stanford University at 20 sites in United States.
Trial summary
The Pediatric Dose Optimization for Seizures in Emergency Medical Services (PediDOSE) study is designed to improve how paramedics treat seizures in children on ambulances. Seizures are one of the most common reasons why people call an ambulance for a child, and paramedics typically administer midazolam to stop the… Read more about this study
- Who is it for?
- Ages 6 months to 13 years
- Conditions the study is for
- Seizures
- What is being tested?
- Standardized seizure protocol and Conventional seizure protocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,700 participants
- Where
- 20 sitesUnited States
- Study dates
- 8 Aug 2022to 30 Sep 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 6 months to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Witnessed by the paramedic to be actively seizing, regardless of seizure type or duration; AND
- Under the care of a paramedic; AND
- Transported by an EMS agency participating in the study
Who cannot join
- A prior history of a benzodiazepine allergy; OR
- Known or presumed pregnancy; OR
- Severe growth restriction based on the paramedic's subjective assessment
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
United States20 sites, 20 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48105
Stacey Noel, MD, 734-763-7488, sknoel@med.umich.edu
- Recruiting
Emory University
Atlanta, Georgia, 30322
Claudia R Morris, MD, 404-727-5500, claudia.r.morris@emory.edu
- Recruiting
University of Colorado
Aurora, Colorado, 80045
Kathleen Adelgais, MD, MPH, 303-724-2595, kathleen.adelgais@childrenscolorado.org
- Recruiting
University at Buffalo
Buffalo, New York, 14203
Brian Clemency, MD, 716-645-9726, bc34@buffalo.edu
- Recruiting
Mecklenburg EMS
Charlotte, North Carolina, 28226
Douglas Swanson, MD, 704-355-2000, dswanson@medic911.com
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Lauren Riney, DO, 513-803-2969, lauren.riney@cchmc.org
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Julie Leonard, MD, MPH, 614-722-4384, julie.leonard@nationwidechildrens.org
- Recruiting
University of Texas Southwestern
Dallas, Texas, 75235
Geoffrey Lowe, MD, 214-456-1359, geoffrey.lowe@utsouthwestern.edu
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Kathryn M Kothari, MD, 832-824-5497, kathryn.kothari@bcm.edu
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Gregory W Faris, MD, 317-962-3886, gfaris@iu.edu
- Recruiting
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Todd P Chang, MD, MAcM, 323-361-2109, tochang@chla.usc.edu
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Lorin Browne, DO, 414-266-2625, lbrowne@mcw.edu
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Sylvia Owusu-Ansah, MD, MPH, 412-692-7692, sylvia.owusuansah@chp.edu
- Recruiting
Oregon Health and Sciences University
Portland, Oregon, 97239
Matthew Hansen, MD, MCR, 503-494-7551, hansemat@ohsu.edu
- Recruiting
University of California, Davis
Sacramento, California, 95817
Daniel Nishijima, MD, MAS, 916-734-3884, dnishijima@ucdavis.edu
- Recruiting
University of Utah
Salt Lake City, Utah, 84108
Maija Holsti, MD, MPH, 801-587-7450, maija.holsti@hsc.utah.edu
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Nicolaus Glomb, MD, MPH, 415-476-3345, nicolaus.glomb@ucsf.edu
- Recruiting
University of Washington
Seattle, Washington, 98104
Andrew Latimer, MD, 206-521-1588, alatim@uw.edu
- Recruiting
University of Arizona
Tucson, Arizona, 85724
Joshua B Gaither, MD, 520-626-1670, jgaither@aemrc.arizona.edu
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
Kathleen Brown, MD, 202-476-4177, kbrown@childrensnational.org
About this study
Official title: Pediatric Dose Optimization for Seizures in EMS (PediDOSE)
The Pediatric Dose Optimization for Seizures in Emergency Medical Services (PediDOSE) study is designed to improve how paramedics treat seizures in children on ambulances. Seizures are one of the most common reasons why people call an ambulance for a child, and paramedics typically administer midazolam to stop the seizure. One-third of children with active seizures on ambulances arrive at emergency departments still seizing. Prior research suggests that seizures on ambulances continue due to under-dosing and delayed delivery of medication. Under-dosing happens when calculation errors occur, and delayed medication delivery occurs due to the time required for dose calculation and placement of an intravenous line to give the medication. Seizures stop quickly when standardized medication doses are given as a muscular injection or a nasal spray. This research has primarily been done in adults, and evidence is needed to determine if this is effective and safe in children.
PediDOSE optimizes how paramedics choose the midazolam dose by eliminating calculations and making the dose age-based. This study involves changing the seizure treatment protocols for ambulance services in 20 different cities, in a staggered and randomly-assigned manner.
Read more
One aim of PediDOSE is to determine if using age to select one of four standardized doses of midazolam and giving it as a muscular injection or nasal spray is more effective than the current calculation-based method, as measured by the number of children arriving at emergency departments still seizing. The investigators believe that a standardized seizure protocol with age-based doses is more effective than current practice.
Another aim of PediDOSE is to determine if a standardized seizure protocol with age-based doses is just as safe as current practice, since either ongoing seizures or receiving too much midazolam can interfere with breathing. The investigators believe that a standardized seizure protocol with age-based doses is just as safe as current practice, since the seizures may stop faster and these doses are safely used in children in other healthcare settings.
If this study demonstrates that standardized, age-based midazolam dosing is equally safe and more effective in comparison to current practice, the potential impact of this study is a shift in the treatment of pediatric seizures that can be easily implemented in ambulance services across the United States and in other parts of the world.
- Conditions
- Seizures
- Being tested
- Standardized seizure protocol, Conventional seizure protocol
- Keywords
- Child, Emergency Medical Services
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized seizure protocolDrug
Also called midazolam
The intervention is a standardized seizure protocol for paramedics that prioritizes administration of only intramuscular (IM) or intranasal (IN) midazolam, up to 2 doses given 5 minutes apart, with age-based dosing as follows: 6-16 months (1.25 mg); 17 months-5 years (2.5 mg); 6-11 years (5 mg); 12-13 years (10 mg).
Conventional seizure protocolDrug
Also called midazolam
The control is the EMS agency's current seizure protocol, based on conventional calculation-based dosing. These vary from one EMS agency to the other with respect to recommended midazolam doses ranging from 0.05-0.3 mg/kg and with multiple route choices listed, including intravenous, intraosseous, intramuscular, intranasal, and rectal.
for paramedics that prioritizes administration of only intramuscular (IM) or intranasal (IN) midazolam, up to 2 doses given 5 minutes apart, with age-based dosing as follows: 6-16 months (1.25 mg); 17 months-5 years (2.5 mg); 6-11 years (5 mg); 12-13 years (10 mg).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This arm will be exposed to the study intervention: a standardized seizure protocol. Receives: Drug: Standardized seizure protocol |
| Control | Active comparator | This arm will be exposed to the emergency medical services (EMS) agency's existing seizure protocol; this is the control arm Receives: Drug: Conventional seizure protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizing on emergency department arrival
Binary assessment of whether the participant is seizing or not upon arrival to the emergency department, as measured by either a rapid response electroencephalogram (preferred) or clinical judgement (alternative).
Measured: Between arrival to the emergency department and 10 minutes after arrival
Secondary outcomes (2)
Respiratory failure
A binary assessment of insufficient breathing at any point during EMS care or within 30 minutes of emergency department arrival, defined as having received bag valve mask ventilation, bi-level positive airway pressure, placement of a supraglottic airway or endotracheal intubation.
Measured: Between paramedic arrival on scene until 30 minutes after emergency department arrival
Time to first midazolam administration
Time in minutes from paramedic arrival to the scene until the paramedic administers midazolam to the patient
Measured: From paramedic arrival to the scene until emergency department arrival, assessed up to 1 hour after paramedic scene arrival or 1 minute after emergency department arrival, whichever occurs last
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start8 Aug 2022
- Primary completion31 Jul 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SeizuresStudies of the same condition, open and under way.
- More trials run by Stanford 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a stepped-wedge, cluster-randomized trial. Every 2 months, 1 of the 20 sites will transition, in a staggered manner, from the control (conventional protocol with calculation-based dosing) to the intervention (standardized protocol with age-based dosing), such that all 20 sites will ultimately implement the intervention during the 4-year enrollment period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), University of Utah, Baylor College of Medicine
- Responsible party
- Principal investigator, Manish Shah, Stanford University
- Investigators
- Manish I Shah, MD, MS, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121324
- Sponsor's protocol ID
- 73018
- Other IDs
- U01NS114042, BCM H-49824
- Acronym
- PediDOSE
- Status last verified
- Sep 2025
- First submitted
- 26 Oct 2021
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: After subject enrollment and follow up have been completed, the Data Coordinating Center (DCC) for the study will prepare a final study database for analysis. A releasable database will be produced and completely de-identified in accordance with the definitions provided in the Health Insurance Portability and Accountability Act (HIPAA). Namely, all identifiers specified in HIPAA will be recoded in a manner that will make it impossible to deduce or impute the specific identity of any participant. The database will not contain institutional identifiers. The DCC will also prepare a data dictionary that provides a concise definition of every data element included in the database. If specific data elements have idiosyncrasies that might affect interpretation or analysis, this will be discussed in the dictionary document. In accordance with policies determined by the investigators and funding sponsors, the releasable database will be provided to users in electronic form.
Publications
Shah MI, Ostermayer DG, Browne LR, Studnek JR, Carey JM, Stanford C, Fumo N, Lerner EB. Multicenter Evaluation of Prehospital Seizure Management in Children. Prehosp Emerg Care. 2021 Jul-Aug;25(4):475-486. doi: 10.1080/10903127.2020.1788194. Epub 2020 Jul 17.
PubMed 32589502Carey JM, Studnek JR, Browne LR, Ostermayer DG, Grawey T, Schroter S, Lerner EB, Shah MI. Paramedic-Identified Enablers of and Barriers to Pediatric Seizure Management: A Multicenter, Qualitative Study. Prehosp Emerg Care. 2019 Nov-Dec;23(6):870-881. doi: 10.1080/10903127.2019.1595234. Epub 2019 May 13.
PubMed 30917730Shah MI, Macias CG, Dayan PS, Weik TS, Brown KM, Fuchs SM, Fallat ME, Wright JL, Lang ES. An Evidence-based Guideline for Pediatric Prehospital Seizure Management Using GRADE Methodology. Prehosp Emerg Care. 2014;18 Suppl 1:15-24. doi: 10.3109/10903127.2013.844874. Epub 2013 Dec 3.
PubMed 24298939Johnson AR, Riches NO, VanBuren JM, Corona AE, Jacobsen K, Yang S, Shah MI; Pediatric Emergency Care Applied Research Network (PECARN) PediDOSE Study Investigators. Measuring the efficacy of community consultation in a pediatric exception from informed consent trial. Acad Emerg Med. 2025 May;32(5):506-515. doi: 10.1111/acem.15073. Epub 2024 Dec 29.
PubMed 40365924Kornblith AE, Singh C, Innes JC, Chang TP, Adelgais KM, Holsti M, Kim J, McClain B, Nishijima DK, Rodgers S, Shah MI, Simon HK, VanBuren JM, Ward CE, Counts CR. Analyzing patient perspectives with large language models: a cross-sectional study of sentiment and thematic classification on exception from informed consent. Sci Rep. 2025 Feb 20;15(1):6179. doi: 10.1038/s41598-025-89996-w.
PubMed 39979559Ward CE, Adelgais KM, Holsti M, Jacobsen KK, Simon HK, Morris CR, Gonzalez VM, Lerner G, Ghaffari K, VanBuren JM, Lerner EB, Shah MI; Pediatric Emergency Care Applied Research Network (PECARN) PediDOSE Study Group. Public support for and concerns regarding pediatric dose optimization for seizures in emergency medical services: An exception from informed consent (EFIC) trial. Acad Emerg Med. 2024 Jul;31(7):656-666. doi: 10.1111/acem.14884. Epub 2024 Mar 7.
PubMed 38450918
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Dose Optimization for Seizures in EMS (PediDOSE)
- ClinicalTrials.gov ID
- NCT05121324
- Acronym / sponsor ID
- PediDOSE / 73018
- Conditions
- Seizures
- Keywords
- Child, Emergency Medical Services
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,700 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), University of Utah, Baylor College of Medicine
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Pediatric Dose Optimization for Seizures in Emergency Medical Services (PediDOSE) study is designed to improve how paramedics treat seizures in children on ambulances. Seizures are one of the most common reasons why people call an ambulance for a child, and paramedics typically administer midazolam to stop the seizure. One-third of children with active seizures on ambulances arrive at emergency departments still seizing. Prior research suggests that seizures on ambulances continue due to under-dosing and delayed delivery of medication. Under-dosing happens when calculation errors occur, and delayed medication delivery occurs due to the time required for dose calculation and placement of an intravenous line to give the medication. Seizures stop quickly when standardized medication doses are given as a muscular injection or a nasal spray. This research has primarily been done in adults, and evidence is needed to determine if this is effective and safe in children.
PediDOSE optimizes how paramedics choose the midazolam dose by eliminating calculations and making the dose age-based. This study involves changing the seizure treatment protocols for ambulance services in 20 different cities, in a staggered and randomly-assigned manner.
One aim of PediDOSE is to determine if using age to select one of four standardized doses of midazolam and giving it as a muscular injection or nasal spray is more effective than the current calculation-based method, as measured by the number of children arriving at emergency departments still seizing. The investigators believe that a standardized seizure protocol with age-based doses is more effective than current practice.
Another aim of PediDOSE is to determine if a standardized seizure protocol with age-based doses is just as safe as current practice, since either ongoing seizures or receiving too much midazolam can interfere with breathing. The investigators believe that a standardized seizure protocol with age-based doses is just as safe as current practice, since the seizures may stop faster and these doses are safely used in children in other healthcare settings.
If this study demonstrates that standardized, age-based midazolam dosing is equally safe and more effective in comparison to current practice, the potential impact of this study is a shift in the treatment of pediatric seizures that can be easily implemented in ambulance services across the United States and in other parts of the world.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a stepped-wedge, cluster-randomized trial. Every 2 months, 1 of the 20 sites will transition, in a staggered manner, from the control (conventional protocol with calculation-based dosing) to the intervention (standardized protocol with age-based dosing), such that all 20 sites will ultimately implement the intervention during the 4-year enrollment period.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Standardized seizure protocolThis arm will be exposed to the study intervention: a standardized seizure protocol. |
| Control | Active comparator | Drug: Conventional seizure protocolThis arm will be exposed to the emergency medical services (EMS) agency's existing seizure protocol; this is the control arm |
Who may qualify
- Ages
- 6 months to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Witnessed by the paramedic to be actively seizing, regardless of seizure type or duration; AND
- Under the care of a paramedic; AND
- Transported by an EMS agency participating in the study
Key exclusion criteria (3 listed)
- A prior history of a benzodiazepine allergy; OR
- Known or presumed pregnancy; OR
- Severe growth restriction based on the paramedic's subjective assessment
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 |
|---|---|---|
| Standardized seizure protocolAlso: midazolamThe intervention is a standardized seizure protocol for paramedics that prioritizes administration of only intramuscular (IM) or intranasal (IN) midazolam, up to 2 doses given 5 minutes apart, with age-based dosing as follows: 6-16 months (1.25 mg); 17 months-5 years (2.5 mg); 6-11 years (5 mg); 12-13 years (10 mg). | Drug | Intervention |
| Conventional seizure protocolAlso: midazolamThe control is the EMS agency's current seizure protocol, based on conventional calculation-based dosing. These vary from one EMS agency to the other with respect to recommended midazolam doses ranging from 0.05-0.3 mg/kg and with multiple route choices listed, including intravenous, intraosseous, intramuscular, intranasal, and rectal. for paramedics that prioritizes administration of only intramuscular (IM) or intranasal (IN) midazolam, up to 2 doses given 5 minutes apart, with age-based dosing as follows: 6-16 months (1.25 mg); 17 months-5 years (2.5 mg); 6-11 years (5 mg); 12-13 years (10 mg). | Drug | Control |
Primary outcome
Seizing on emergency department arrival
Time frame: Between arrival to the emergency department and 10 minutes after arrival
Binary assessment of whether the participant is seizing or not upon arrival to the emergency department, as measured by either a rapid response electroencephalogram (preferred) or clinical judgement (alternative).
2 secondary outcomes
Respiratory failure
Time frame: Between paramedic arrival on scene until 30 minutes after emergency department arrival
Time to first midazolam administration
Time frame: From paramedic arrival to the scene until emergency department arrival, assessed up to 1 hour after paramedic scene arrival or 1 minute after emergency department arrival, whichever occurs last
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Background: PubMed 32589502Shah MI, Ostermayer DG, Browne LR, Studnek JR, Carey JM, Stanford C, Fumo N, Lerner EB. Multicenter Evaluation of Prehospital Seizure Management in Children. Prehosp Emerg Care. 2021 Jul-Aug;25(4):475-486. doi: 10.1080/10903127.2020.1788194. Epub 2020 Jul 17.
- Background: PubMed 30917730Carey JM, Studnek JR, Browne LR, Ostermayer DG, Grawey T, Schroter S, Lerner EB, Shah MI. Paramedic-Identified Enablers of and Barriers to Pediatric Seizure Management: A Multicenter, Qualitative Study. Prehosp Emerg Care. 2019 Nov-Dec;23(6):870-881. doi: 10.1080/10903127.2019.1595234. Epub 2019 May 13.
- Background: PubMed 24298939Shah MI, Macias CG, Dayan PS, Weik TS, Brown KM, Fuchs SM, Fallat ME, Wright JL, Lang ES. An Evidence-based Guideline for Pediatric Prehospital Seizure Management Using GRADE Methodology. Prehosp Emerg Care. 2014;18 Suppl 1:15-24. doi: 10.3109/10903127.2013.844874. Epub 2013 Dec 3.
- Results publication: PubMed 40365924Johnson AR, Riches NO, VanBuren JM, Corona AE, Jacobsen K, Yang S, Shah MI; Pediatric Emergency Care Applied Research Network (PECARN) PediDOSE Study Investigators. Measuring the efficacy of community consultation in a pediatric exception from informed consent trial. Acad Emerg Med. 2025 May;32(5):506-515. doi: 10.1111/acem.15073. Epub 2024 Dec 29.
- Results publication: PubMed 39979559Kornblith AE, Singh C, Innes JC, Chang TP, Adelgais KM, Holsti M, Kim J, McClain B, Nishijima DK, Rodgers S, Shah MI, Simon HK, VanBuren JM, Ward CE, Counts CR. Analyzing patient perspectives with large language models: a cross-sectional study of sentiment and thematic classification on exception from informed consent. Sci Rep. 2025 Feb 20;15(1):6179. doi: 10.1038/s41598-025-89996-w.
- Results publication: PubMed 38450918Ward CE, Adelgais KM, Holsti M, Jacobsen KK, Simon HK, Morris CR, Gonzalez VM, Lerner G, Ghaffari K, VanBuren JM, Lerner EB, Shah MI; Pediatric Emergency Care Applied Research Network (PECARN) PediDOSE Study Group. Public support for and concerns regarding pediatric dose optimization for seizures in emergency medical services: An exception from informed consent (EFIC) trial. Acad Emerg Med. 2024 Jul;31(7):656-666. doi: 10.1111/acem.14884. Epub 2024 Mar 7.
- Individual participant dataSharing planned: Yes. After subject enrollment and follow up have been completed, the Data Coordinating Center (DCC) for the study will prepare a final study database for analysis. A releasable database will be produced and completely de-identified in accordance with the definitions provided in the Health Insurance Portability and Accountability Act (HIPAA). Namely, all identifiers specified in HIPAA will be recoded in a manner that will make it impossible to deduce or impute the specific identity of any participant. The database will not contain institutional identifiers. The DCC will also prepare a data dictionary that provides a concise definition of every data element included in the database. If specific data elements have idiosyncrasies that might affect interpretation or analysis, this will be discussed in the dictionary document. In accordance with policies determined by the investigators and funding sponsors, the releasable database will be provided to users in electronic form.
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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.
Manish I Shah, MD, MS principal investigator
Stanford University
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standardized seizure protocol and Conventional seizure protocol in people with Seizures, run by Stanford University at 20 sites in United States.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manish I Shah, MD, MS (650-723-3319, mshah5@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizing on emergency department arrival (time frame: Between arrival to the emergency department and 10 minutes after arrival). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05121324, which also lists 6 linked publications.
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 30 Sep 2025.