Trial · NCT01960075
Established Status Epilepticus Treatment Trial
NCT01960075, Phase 3, Completed, University of Virginia; results first posted 2020-02-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Established Status Epilepticus Treatment Trial. Trials, record NCT01960075. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01960075
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Established Status Epilepticus Treatment Trial
- NCT number
- NCT01960075
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 478 participants, actual
- Lead sponsor
- University of Virginia
- Conditions
- Benzodiazepine Refractory Status Epilepticus
- Interventions
- Fosphenytoin, Levetiracetam, Valproic acid
- First posted
- 2013-10-10
- Last updated
- 2021-06-14
- Results first posted
- 2020-02-28
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Clinical Cessation of Status Epilepticus - Intention to Treat | Within 60 minutes after the start of study drug infusion | Determined by the absence of clinically apparent seizures and improving consciousness at 1 hour without other anticonvulsant medications. Intention to treat |
| Primary | Number of Participants With Clinical Cessation of Status Epilepticus - Per-protocol Analysis | Within 60 minutes after the start of study drug infusion | Determined by the absence of clinically apparent seizures and improving consciousness at 1 hour without other anticonvulsant medications. Per-protocol analysis |
| Primary | Number of Participants With Clinical Cessation of Status Epilepticus - Adjudicated Outcomes Analysis | Within 60 minutes after the start of study drug infusion | Determined by the absence of clinically apparent seizures and improving consciousness at 1 hour without other anticonvulsant medications. The Adjudicated outcomes analysis is different from Outcome measure 1 because a central clinical phenomenology core of four neurologists adjudicated from the medical records the time to seizure cessation, the time in status epilepticus before trial-drug initiation, and the cause of the seizure. For each enrollment, two neurologists from this core group conducted independent initial reviews and then determined a consensus or consulted a third adjudicator, as needed. Adjudicators were unaware of the treatment assignments and made determinations by medical record review. |
| Secondary | Number of Participants With Admission to Intensive Care Unit | Admission to intensive care unit after start of study drug infusion, where the ICU is the initial inpatient unit for the patient | ICU admission is recorded as occurring only if the ICU is the initial inpatient unit for the patient. |
| Secondary | Length of ICU Stay | number of calendar days after the day of ED arrival until hospital discharge or subject end-of-study | Length of stay is determined by the number of calendar days after the day of ED arrival until hospital discharge or subject end-of-study. |
| Secondary | Minutes From Start of Trial Drug Infusion to Termination of Seizures for Patients With Treatment Success | start of drug infusion to seizure cessation | The time to termination of seizures is the interval from the start of study drug infusion to cessation of clinically apparent seizure in those who meet the primary outcome. |
| Secondary | Number of Participants With Seizure Cessation Within 20 Minutes for Patients With Treatment Success | within 20 minutes | Number of participants with seizure cessation within 20 minutes of study drug initiation for patients with treatment success. This outcome measure was only reported in the Supplementary materials to the Primary Paper. |
| Secondary | Length of Hospital Stay | length of hospital stay | Length of hospital stay in days |
| Other | Number of Participants With Safety Outcome: Life Threatening Hypotension | within 60 minutes of the start of study drug infusion | Life-threatening hypotension within 60 minutes of the start of study drug infusion |
| Other | Number of Participants With Safety Outcome: Life-threatening Cardiac Arrhythmia | within 60 minutes of the start of study drug infusion | Life-threatening cardiac arrhythmia within 60 minutes of the start of study drug infusion |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Clinical Cessation of Status Epilepticus - Intention to Treat | Within 60 minutes after the start of study drug infusion | The difference from Participant Flow is because the total of 384 is from the first 400 patients and excludes 16 re-enrollers in the study. The first 400 patients were used because of the prespecified stopping rule and the trial stopped for futility. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinical Cessation of Status Epilepticus - Per-protocol Analysis | Within 60 minutes after the start of study drug infusion | The analysis population for this outcome is the Per-protocol population, which is all patients who completed the study without major protocol deviations. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinical Cessation of Status Epilepticus - Adjudicated Outcomes Analysis | Within 60 minutes after the start of study drug infusion | The difference from Participant Flow is because the total of 384 is from the first 400 patients and excludes 16 re-enrollers in the study. The first 400 patients were used because of the prespecified stopping rule and the trial stopped for futility. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Admission to Intensive Care Unit | Admission to intensive care unit after start of study drug infusion, where the ICU is the initial inpatient unit for the patient | The difference from Participant Flow is because the total of 384 is from the first 400 patients and excludes 16 re-enrollers in the study. The first 400 patients were used because of the prespecified stopping rule and the trial stopped for futility. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Length of ICU Stay | number of calendar days after the day of ED arrival until hospital discharge or subject end-of-study | The difference from Participant Flow is because the total of 384 is from the first 400 patients and excludes 16 re-enrollers in the study. The first 400 patients were used because of the prespecified stopping rule and the trial stopped for futility. | days | MEDIAN |
| SECONDARY | Minutes From Start of Trial Drug Infusion to Termination of Seizures for Patients With Treatment Success | start of drug infusion to seizure cessation | The analysis population here is different than Participant Flow because it includes only the patients who had this data available. The first 400 patients were used because of the prespecified stopping rule and the trial stopped for futility. | minutes | MEDIAN |
| SECONDARY | Number of Participants With Seizure Cessation Within 20 Minutes for Patients With Treatment Success | within 20 minutes | The population is different than Participant flow because it is only those with treatment success. This outcome measure was only reported in the Supplementary materials to the Primary Paper. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Length of Hospital Stay | length of hospital stay | The difference from Participant Flow is because the total of 384 is from the first 400 patients and excludes 16 re-enrollers in the study. The first 400 patients were used because of the prespecified stopping rule and the trial stopped for futility. | days | MEDIAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Safety Outcome: Life Threatening Hypotension | within 60 minutes of the start of study drug infusion | The first 400 patients were analyzed for this outcome. The first 400 patients were used because of the prespecified stopping rule and the trial stopped for futility. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Safety Outcome: Life-threatening Cardiac Arrhythmia | within 60 minutes of the start of study drug infusion | The first 400 patients were analyzed for this outcome. The first 400 patients were used because of the prespecified stopping rule and the trial stopped for futility. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group51
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Clinical Cessation of Status Epilepticus - Intention to Treat | Fosphenytoin (FOS) | 53 | Participants | ||
| Number of Participants With Clinical Cessation of Status Epilepticus - Intention to Treat | Valproic Acid | 56 | Participants | ||
| Number of Participants With Clinical Cessation of Status Epilepticus - Intention to Treat | Levetiracetam | 68 | Participants | ||
| Number of Participants With Clinical Cessation of Status Epilepticus - Per-protocol Analysis | Fosphenytoin (FOS) | 37 | Participants | ||
| Number of Participants With Clinical Cessation of Status Epilepticus - Per-protocol Analysis | Valproic Acid | 43 | Participants | ||
| Number of Participants With Clinical Cessation of Status Epilepticus - Per-protocol Analysis | Levetiracetam | 51 | Participants | ||
| Number of Participants With Clinical Cessation of Status Epilepticus - Adjudicated Outcomes Analysis | Fosphenytoin (FOS) | 57 | Participants | ||
| Number of Participants With Clinical Cessation of Status Epilepticus - Adjudicated Outcomes Analysis | Valproic Acid | 60 | Participants | ||
| Number of Participants With Clinical Cessation of Status Epilepticus - Adjudicated Outcomes Analysis | Levetiracetam | 67 | Participants | ||
| Number of Participants With Admission to Intensive Care Unit | Fosphenytoin (FOS) | 70 | Participants |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fosphenytoin (FOS) | 149 | |
| Overall Study | STARTED | Valproic Acid | 149 | |
| Overall Study | STARTED | Levetiracetam | 180 | |
| Overall Study | COMPLETED | Fosphenytoin (FOS) | 141 | |
| Overall Study | COMPLETED | Valproic Acid | 146 | |
| Overall Study | COMPLETED | Levetiracetam | 173 | |
| Overall Study | NOT COMPLETED | Fosphenytoin (FOS) | 8 | |
| Overall Study | NOT COMPLETED | Valproic Acid | 3 | |
| Overall Study | NOT COMPLETED | Levetiracetam | 7 |
Source ClinicalTrials.gov
Adverse events288
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Fosphenytoin (FOS) | 1 | 125 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Valproic Acid | 0 | 125 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Levetiracetam | 0 | 150 | 0 |
| other | Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Fosphenytoin (FOS) | 0 | 125 | 0 |
| other | Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Valproic Acid | 0 | 125 | 0 |
| other | Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Levetiracetam | 1 | 150 | 1 |
| other | Agitation | Psychiatric disorders | Fosphenytoin (FOS) | 0 | 125 | 0 |
| other | Agitation | Psychiatric disorders | Valproic Acid | 1 | 125 | 1 |
| other | Agitation | Psychiatric disorders | Levetiracetam | 0 | 150 | 0 |
| other | Apnoea | Respiratory, thoracic and mediastinal disorders | Fosphenytoin (FOS) | 1 | 125 | 1 |
1 to 10 of 288Source ClinicalTrials.gov
See all 288 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fosphenytoin (FOS) | 3 | 125 |
| Total, all-cause mortality | Valproic Acid | 2 | 125 |
| Total, all-cause mortality | Levetiracetam | 7 | 150 |
| Total, other adverse events | Fosphenytoin (FOS) | 28 | 125 |
| Total, other adverse events | Valproic Acid | 22 | 125 |
| Total, other adverse events | Levetiracetam | 25 | 150 |
| Total, serious adverse events | Fosphenytoin (FOS) | 57 | 125 |
| Total, serious adverse events | Valproic Acid | 46 | 125 |
| Total, serious adverse events | Levetiracetam | 64 | 150 |
Source ClinicalTrials.gov
Papers11
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01NS088034 | Established Status Epilepticus Treatment Trial (ESETT) | KAPUR, JAIDEEP; CHAMBERLAIN, JAMES; SILBERGLEIT, ROBERT | UNIVERSITY OF VIRGINIA | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2014 to 2018 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01960075
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