Trial · NCT02239380
Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan
NCT02239380, Phase 3, Completed, Pfizer; results first posted 2019-02-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan. Trials, record NCT02239380. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02239380
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan
- NCT number
- NCT02239380
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 26 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Status Epilepticus
- Interventions
- Lorazepam
- First posted
- 2014-09-12
- Last updated
- 2019-02-18
- Other registries' IDs
- eudract:2017-000125-13
- Results first posted
- 2019-02-18
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Initial Dose (Dose 1) of Study Drug | 30 minutes post Dose 1 | Participants with clinical benefit were defined as participants whose initial seizure stopped within 10 minutes after initial dose (Dose 1) and who continued seizure-free for at least 30 minutes after the completion of initial dose (Dose 1). |
| Secondary | Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Any Dose of Study Drug | 30 minutes post Dose 1 or 2 | Percentage of participants whose initial seizure stopped within 10 minutes after the administration of study drug (either Dose 1 or 2 \[in 10 to 30 minutes from the initial dose\]) and who continued seizure-free for at least 30 minutes were analyzed and reported in this outcome measure. |
| Secondary | Percentage of Participants Who Achieved Seizure Free Interval of At Least 12 Hours After Administration (Either Initial or Any Dose) of Study Drug | 12 hour post Dose 1; 12 hour post Dose 1 or 2 | Percentage of participants whose seizures stopped within 10 minutes after the administration of initial dose (Dose 1) of study drug and after any study drug dose (either Dose 1 or Dose 2 \[in 10 to 30 minutes from the initial dose\]), who continued to be seizure-free for at least 12 hours post-dose were analyzed and reported in this outcome measure. |
| Secondary | Percentage of Participants Who Achieved Seizure Free Interval of At Least 24 Hours After Administration (Either Initial or Any Dose) of Study Drug | 24 hour post Dose 1; 24 hour post Dose 1 or 2 | Percentage of participants whose seizures stopped within 10 minutes after the administration of initial dose (Dose 1) of study drug and after any study drug dose (either Dose 1 or Dose 2 \[in 10 to 30 minutes from the initial dose\]), who continued to be seizure-free for at least 24 hours post-dose were analyzed and reported in this outcome measure. |
| Secondary | Time to Resolution of Seizures From The Administration (Either Initial or Any Dose) of Study Drug | 10 minutes post Dose 1; 10 minutes post Dose 1 or 2 | Time to resolution (in minutes) was defined as the duration between the administration of study drug until the seizure resolved without receiving the prohibited medications. |
| Secondary | Time to Relapse Following The Administration (Either Initial or Any Dose) of Study Drug | 24 hour post Dose 1; 24 hour post Dose 1 or 2 | Time to relapse (in minutes) was defined as duration from the time of study drug administration to the time of relapse, as determined by investigator. Participants whose seizure stops within 10 minutes without receiving the prohibited medications were analyzed in this outcome measure. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 7 days after last dose of study drug administration (up to 12 days) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug to the end of study (Day 12), that were absent before treatment or that worsened relative to pre-treatment state. AEs include both serious and non-serious adverse events. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Initial Dose (Dose 1) of Study Drug | 30 minutes post Dose 1 | Full analysis set (FAS) included all participants who received at least 1 dose of study drug, excluded those participants whose status epilepticus (SE) or repetitive SE/cluster seizure was determined on the electroencephalography (EEG). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Any Dose of Study Drug | 30 minutes post Dose 1 or 2 | FAS included all participants who received at least 1 dose of study drug, excluded those participants whose SE or repetitive SE/cluster seizure was determined on the EEG. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Seizure Free Interval of At Least 12 Hours After Administration (Either Initial or Any Dose) of Study Drug | 12 hour post Dose 1; 12 hour post Dose 1 or 2 | FAS included all participants who received at least 1 dose of study drug, excluded those participants whose SE or repetitive SE/cluster seizure was determined on the EEG. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Seizure Free Interval of At Least 24 Hours After Administration (Either Initial or Any Dose) of Study Drug | 24 hour post Dose 1; 24 hour post Dose 1 or 2 | FAS included all participants who received at least 1 dose of study drug, excluded those participants whose SE or repetitive SE/cluster seizure was determined on the EEG. | percentage of participants | NUMBER |
| SECONDARY | Time to Resolution of Seizures From The Administration (Either Initial or Any Dose) of Study Drug | 10 minutes post Dose 1; 10 minutes post Dose 1 or 2 | FAS included all participants who received at least 1 dose of study drug, excluded those participants whose SE or repetitive SE/cluster seizure was determined on the EEG. Here, 'n' signifies those participants who were evaluable for specific category. | minutes | MEDIAN |
| SECONDARY | Time to Relapse Following The Administration (Either Initial or Any Dose) of Study Drug | 24 hour post Dose 1; 24 hour post Dose 1 or 2 | FAS included all participants who received at least 1 dose of study drug, excluded those participants whose SE or repetitive SE/cluster seizure was determined on the EEG. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure. | minutes | MEDIAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 7 days after last dose of study drug administration (up to 12 days) | Safety analysis set included all participants who received at least 1 dose of study drug. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Initial Dose (Dose 1) of Study Drug | Lorazepam | 48.0 | 95% Confidence Interval 27.8 to 68.7 | percentage of participants | |
| Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Any Dose of Study Drug | Lorazepam | 64.0 | 95% Confidence Interval 42.5 to 82.0 | percentage of participants | |
| Percentage of Participants Who Achieved Seizure Free Interval of At Least 12 Hours After Administration (Either Initial or Any Dose) of Study Drug | Lorazepam | Post Dose 1 | 32.0 | percentage of participants | |
| Percentage of Participants Who Achieved Seizure Free Interval of At Least 12 Hours After Administration (Either Initial or Any Dose) of Study Drug | Lorazepam | Post Dose 1 or 2 | 44.0 | percentage of participants | |
| Percentage of Participants Who Achieved Seizure Free Interval of At Least 24 Hours After Administration (Either Initial or Any Dose) of Study Drug | Lorazepam | Post Dose 1 | 24.0 | percentage of participants | |
| Percentage of Participants Who Achieved Seizure Free Interval of At Least 24 Hours After Administration (Either Initial or Any Dose) of Study Drug | Lorazepam | Post Dose 1 or 2 | 32.0 | percentage of participants | |
| Time to Resolution of Seizures From The Administration (Either Initial or Any Dose) of Study Drug | Lorazepam | Post Dose 1 | 1.0 | Full Range 0 to 10 | minutes |
| Time to Resolution of Seizures From The Administration (Either Initial or Any Dose) of Study Drug | Lorazepam | Post Dose 1 or 2 | 1.0 | Full Range 0 to 10 | minutes |
| Time to Relapse Following The Administration (Either Initial or Any Dose) of Study Drug | Lorazepam | Post Dose 1 | 62.0 | Full Range 11 to 879 | minutes |
| Time to Relapse Following The Administration (Either Initial or Any Dose) of Study Drug | Lorazepam | Post Dose 1 or 2 | 103.0 | Full Range 23 to 1246 | minutes |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lorazepam | 26 | |
| Overall Study | COMPLETED | Lorazepam | 26 | |
| Overall Study | NOT COMPLETED | Lorazepam | 0 |
Source ClinicalTrials.gov
Adverse events15
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 | Vomiting | Gastrointestinal disorders | Lorazepam | 1 | 26 | |
| other | Pyrexia | General disorders | Lorazepam | 1 | 26 | |
| other | Pneumonia | Infections and infestations | Lorazepam | 1 | 26 | |
| other | Urinary tract infection | Infections and infestations | Lorazepam | 1 | 26 | |
| other | Fall | Injury, poisoning and procedural complications | Lorazepam | 1 | 26 | |
| other | Laceration | Injury, poisoning and procedural complications | Lorazepam | 1 | 26 | |
| other | Blood creatine phosphokinase increased | Investigations | Lorazepam | 1 | 26 | |
| other | Ataxia | Nervous system disorders | Lorazepam | 1 | 26 | |
| other | Balance disorder | Nervous system disorders | Lorazepam | 1 | 26 | |
| other | Somnolence | Nervous system disorders | Lorazepam | 2 | 26 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lorazepam | ||
| Total, other adverse events | Lorazepam | 12 | 26 |
| Total, serious adverse events | Lorazepam | 1 | 26 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
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/NCT02239380
GET https://conductscience.org/api/trials/v1/NCT02239380/registered