Established Status Epilepticus Treatment Trial
Public ClinicalTrials.gov record NCT01960075. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Blinded, Comparative Effectiveness Study of Fosphenytoin, Valproic Acid, or Levetiracetam in the Emergency Department Treatment of Patients With Benzodiazepine-refractory Status Epilepticus.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective is to determine the most effective and/or the least effective treatment of benzodiazepine-refractory status epilepticus (SE) among patients older than 2 years. There are three active treatment arms being compared: fosphenytoin (FOS),levetiracetam (LEV), and valproic acid (VPA). The second objective is comparison of three drugs with respect to secondary outcomes. The final objective is to ensure that the trial is informative for treatment of established SE in children by describing the effectiveness, safety, and rate of adverse reactions of these drugs in children.
Study identification
- NCT ID
- NCT01960075
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 478 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2015 (Type not available)
- Primary completion
- Feb 2019 (Actual)
- Completion
- May 2019 (Actual)
- Last update posted
- Jun 14, 2021
2015 – 2019
United States locations
- U.S. sites
- 65
- U.S. states
- 21
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner University Medical Center - South Campus | Tucson | Arizona | 85713 | — |
| Banner University Medical Center-Tucson Campus | Tucson | Arizona | 85724 | — |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | — |
| UC Davis Children's Hospital | Sacramento | California | 95817 | — |
| San Francisco General Hospital | San Francisco | California | 94110 | — |
| UCSF Medical Center | San Francisco | California | 94143 | — |
| UCSF Benioff Children's Hospital | San Francisco | California | 94145 | — |
| Stanford University Medical Center | Stanford | California | 94305 | — |
| Christiana Hospital | Newark | Delaware | 19718 | — |
| A.I.DuPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20310 | — |
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | — |
| Children's Healthcare of Atlanta at Egleston | Atlanta | Georgia | 30322 | — |
| University of Kentucky Hospital | Lexington | Kentucky | 40536 | — |
| University of maryland Medical Center | Baltimore | Maryland | 21201 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| C.S. Mott Children's Hospital | Ann Arbor | Michigan | 48109 | — |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109 | — |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | — |
| Detroit Receiving Hospital | Detroit | Michigan | 48201 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Sinai-Grace Hospital | Detroit | Michigan | 48235 | — |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | — |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | — |
| University of Minnesota Medical Center | Minneapolis | Minnesota | 55454 | — |
| University of Minnesota Masonic Children's Hospital | Minneapolis | Minnesota | 55455 | — |
| Regions Hospital | Saint Paul | Minnesota | 55101 | — |
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Kings County Hospital Center | Brooklyn | New York | 11203 | — |
| SUNY Downstate Medical Center | Brooklyn | New York | 11203 | — |
| Maimonides Medical Center | Brooklyn | New York | 11219 | — |
| NYP Columbia University Medical Center | New York | New York | 10032 | — |
| NYP Morgan Stanley Children's Hospital | New York | New York | 10032 | — |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| OSU Wexner Medical Center | Columbus | Ohio | 43210 | — |
| Oregon Health & Science University Hospital | Portland | Oregon | 97239 | — |
| Crozer-Chester Medical Center | Chester | Pennsylvania | 19013 | — |
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Hahnemann University Hospital | Philadelphia | Pennsylvania | 19102 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | — |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19107 | — |
| Temple University Hospital Episcopal Campus | Philadelphia | Pennsylvania | 19125 | — |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | — |
| Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| UPMC Presbyterian Hospital | Pittsburgh | Pennsylvania | 15213 | — |
| UPMC Mercy Hospital | Pittsburgh | Pennsylvania | 15219 | — |
| Children's Hospital of Pittsburgh UPMC | Pittsburgh | Pennsylvania | 15224 | — |
| Hasbro Children's Hospital | Providence | Rhode Island | 02903 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Children's Medical Center UTSW | Dallas | Texas | 75390 | — |
| Lyndon B. Johnson General Hospital | Houston | Texas | 77026 | — |
| Memorial Hermann Texas medical Center | Houston | Texas | 77030 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| University Health System University Hospital | San Antonio | Texas | 78229 | — |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
| VCU Medical Center | Richmond | Virginia | 23298 | — |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
| Froedtert Memorial Lutheran Hospital | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01960075, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 14, 2021 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01960075 live on ClinicalTrials.gov.