Trial · NCT04391569
Randomized Therapy In Status Epilepticus
NCT04391569, Phase 3, Completed, Marinus Pharmaceuticals; results first posted 2025-05-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Randomized Therapy In Status Epilepticus. Trials, record NCT04391569. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04391569
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Therapy In Status Epilepticus
- NCT number
- NCT04391569
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 100 participants, actual
- Lead sponsor
- Marinus Pharmaceuticals
- Conditions
- Status Epilepticus
- Interventions
- Ganaxolone, Placebo
- First posted
- 2020-05-18
- Last updated
- 2025-05-29
- Results first posted
- 2025-05-29
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With SE Cessation Within 30 Minutes of Investigational Product (IP) Initiation Without Medications for the Acute Treatment of SE | Up to 30 minutes | SE cessation was determined by the investigator based on clinical and electroencephalography (EEG). Medications for the acute treatment of SE were defined as antiepileptic drugs (AEDs) administered to abort ongoing SE or prevent imminent recurrence of SE based on clinical or EEG evidence. |
| Primary | Percentage of Participants With no Progression to Intravenous (IV) Anesthesia for 36 Hours Following Investigational Product (IP) Initiation | Up to 36 hours after IP initiation | Percentage of participants with no progression to IV anesthesia for 36 hours following IP initiation SE cessation was based on investigator report with confirmation by assessment of concomitant medication data. |
| Primary | Number of Participants With Treatment Emergent Adverse Events | Up to 4 weeks after IP initiation | An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant who has been administered a pharmaceutical product; it does not necessarily have a causal relationship with this treatment. Treatment-emergent adverse event (TEAE) is defined as an AE that occurred or worsened at the time of or following IP initiation. |
| Secondary | Percentage of Participants With no Progression to IV Anesthesia for 72 Hours Following IP Initiation | Up to 72 hours after IP initiation | Percentage of participants with no progression to IV anesthesia for 72 hours following IP initiation SE cessation was assessed by the investigator based on clinical and EEG features. |
| Secondary | Time to SE Cessation Following IP Initiation | Up to 72 hours after IP initiation | Time to SE cessation was assessed for the first 72 hours following IP using the Kaplan-Meier method. |
| Secondary | Percentage of Participants With Any Escalation of Treatment in the First 24 Hours Following IP Initiation | Up to 24 hours after IP initiation | SE cessation will be determined by the investigator based on clinical and EEG. Percentage of participants with any escalation of treatment in the first 24 hours following IP initiation, i.e. any medication other than IP administered for the acute treatment of SE in the first 24 hours following IP initiation was summarized |
| Secondary | Time to Treatment Escalation in the First 24 Hours Following IP Initiation | Up to 24 hours after IP initiation | For time to treatment escalation (any mediation used for acute treatment of SE), the estimates are based descriptive statistics on participants with treatment escalation in the first 24 hours following IP initiation. For participants without treatment escalation, the time to treatment escalation was censored at IP completion, or discontinuation from the study or death, whichever occurs earlier. The median time to treatment escalation has been presented. |
| Secondary | Time to Initiation of Anesthesia for SE Treatment Through the Final Study Follow-up Visit/Contact | Up to 4 Weeks following IP initiation | Time to initiation of anesthesia for SE treatment through the final study follow-up visit/contact, were calculated based on descriptive statistics. The estimate was censored at study discontinuation, death, or last follow-up of the participant, whichever occurs first. The median time to initiation of anesthesia has been presented. |
| Secondary | Percentage of Participants Who Develop Super Refractory Status Epilepticus (SRSE) Through the Final Study Follow-up Visit/Contact | Up to 4 Weeks following IP initiation | Percentage of participants who developed SRSE through the final study follow-up visit/contact was provided for each treatment group. |
| Secondary | Percent Change From Baseline in Seizure Burden Through 72 Hours Following IP Initiation | Up to 72 hours after IP initiation | The seizure burden through 72 hours following IP initiation is described as the percent of time during which there is electrographic seizure activity from IP initiation to 72 hours. The change from baseline of seizure burden was summarized using descriptive statistics by treatment group. The baseline seizure burden is defined for 30 minutes prior to IP initiation. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With SE Cessation Within 30 Minutes of Investigational Product (IP) Initiation Without Medications for the Acute Treatment of SE | Up to 30 minutes | Intent-To-Treat (ITT) population comprised of all randomized participants in the double-blind phase of the study who received IP and had at least one non-missing efficacy assessment. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With no Progression to Intravenous (IV) Anesthesia for 36 Hours Following Investigational Product (IP) Initiation | Up to 36 hours after IP initiation | ITT population | Percentage of participants | NUMBER |
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events | Up to 4 weeks after IP initiation | Safety Population | Participants | NUMBER |
| SECONDARY | Percentage of Participants With no Progression to IV Anesthesia for 72 Hours Following IP Initiation | Up to 72 hours after IP initiation | ITT population | Percentage of participants | NUMBER |
| SECONDARY | Time to SE Cessation Following IP Initiation | Up to 72 hours after IP initiation | ITT population | hours | MEDIAN |
| SECONDARY | Percentage of Participants With Any Escalation of Treatment in the First 24 Hours Following IP Initiation | Up to 24 hours after IP initiation | Intent-To-Treat (ITT) population comprised of all randomized participants in the double-blind phase of the study who received IP and had at least one non-missing efficacy assessment. | Percentage of participants | NUMBER |
| SECONDARY | Time to Treatment Escalation in the First 24 Hours Following IP Initiation | Up to 24 hours after IP initiation | ITT population. Participants with treatment escalation following IP initiation were analyzed. | hours | MEDIAN |
| SECONDARY | Time to Initiation of Anesthesia for SE Treatment Through the Final Study Follow-up Visit/Contact | Up to 4 Weeks following IP initiation | ITT population. Participants who initiated anesthesia for SE treatment were analyzed. | hours | MEDIAN |
| SECONDARY | Percentage of Participants Who Develop Super Refractory Status Epilepticus (SRSE) Through the Final Study Follow-up Visit/Contact | Up to 4 Weeks following IP initiation | ITT population | Percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Seizure Burden Through 72 Hours Following IP Initiation | Up to 72 hours after IP initiation | ITT population. Participants with percent change from Baseline in seizure burden through 72 hours has been presented. | Percent change | MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With SE Cessation Within 30 Minutes of Investigational Product (IP) Initiation Without Medications for the Acute Treatment of SE | Ganaxolone | 79.59 | 95% Confidence Interval 65.657 to 89.755 | Percentage of participants | |
| Percentage of Participants With SE Cessation Within 30 Minutes of Investigational Product (IP) Initiation Without Medications for the Acute Treatment of SE | Placebo | 12.77 | 95% Confidence Interval 4.832 to 25.741 | Percentage of participants | |
| Percentage of Participants With no Progression to Intravenous (IV) Anesthesia for 36 Hours Following Investigational Product (IP) Initiation | Ganaxolone | 63.27 | 95% Confidence Interval 48.288 to 76.578 | Percentage of participants | |
| Percentage of Participants With no Progression to Intravenous (IV) Anesthesia for 36 Hours Following Investigational Product (IP) Initiation | Placebo | 51.06 | 95% Confidence Interval 36.064 to 65.924 | Percentage of participants | |
| Number of Participants With Treatment Emergent Adverse Events | Ganaxolone | Any TEAE | 48 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events | Placebo | Any TEAE | 43 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events | Ganaxolone | Serious TEAEs | 19 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events | Placebo | Serious TEAEs | 18 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events | Ganaxolone | TEAE Leading to study drug discontinuation | 1 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events | Placebo | TEAE Leading to study drug discontinuation | 2 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ganaxolone | 51 | |
| Overall Study | STARTED | Placebo | 49 | |
| Overall Study | COMPLETED | Ganaxolone | 30 | |
| Overall Study | COMPLETED | Placebo | 35 | |
| Overall Study | NOT COMPLETED | Ganaxolone | 21 | |
| Overall Study | NOT COMPLETED | Placebo | 14 |
Source ClinicalTrials.gov
Adverse events154
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 | Urinary tract infection | Infections and infestations | Placebo | 4 | 49 | 4 |
| other | Urinary tract infection | Infections and infestations | Ganaxolone | 10 | 51 | 10 |
| other | Pneumonia | Infections and infestations | Placebo | 0 | 49 | 0 |
| other | Pneumonia | Infections and infestations | Ganaxolone | 5 | 51 | 6 |
| other | Pneumonia serratia | Infections and infestations | Placebo | 3 | 49 | 3 |
| other | Pneumonia serratia | Infections and infestations | Ganaxolone | 0 | 51 | 0 |
| other | Staphylococcal infection | Infections and infestations | Placebo | 3 | 49 | 3 |
| other | Staphylococcal infection | Infections and infestations | Ganaxolone | 0 | 51 | 0 |
| other | Klebsiella infection | Infections and infestations | Placebo | 2 | 49 | 2 |
| other | Klebsiella infection | Infections and infestations | Ganaxolone | 0 | 51 | 0 |
1 to 10 of 154Source ClinicalTrials.gov
See all 154 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 11 | 49 |
| Total, all-cause mortality | Ganaxolone | 15 | 51 |
| Total, other adverse events | Placebo | 39 | 49 |
| Total, other adverse events | Ganaxolone | 43 | 51 |
| Total, serious adverse events | Placebo | 18 | 49 |
| Total, serious adverse events | Ganaxolone | 19 | 51 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ganaxolone vs Placebo: deaths from any cause | Trial comparisons |
| Ganaxolone vs Placebo: serious adverse events | Trial comparisons |
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/NCT04391569
GET https://conductscience.org/api/trials/v1/NCT04391569/results?page=2