Trial · NCT03350035
Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus
NCT03350035, Phase 2, Completed, Marinus Pharmaceuticals; results first posted 2022-12-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus. Trials, record NCT03350035. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03350035
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus
- NCT number
- NCT03350035
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Marinus Pharmaceuticals
- Conditions
- Status Epilepticus, Convulsive Status EPILEPTICUS, Non Convulsive Status Epilepticus, Epilepsy
- Interventions
- IV Ganaxolone active, IV Placebo, non-active
- First posted
- 2017-11-22
- Last updated
- 2023-03-09
- Results first posted
- 2022-12-15
- Limitations and caveats
- 2 deaths during the follow-up were extracted from the SAE reconciliation database.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Did Not Require an IV Anesthetic Drug for SE Treatment | 24 hours post study drug initiation | Number of participants who did not require an intravenous (IV) Anesthetic Drug (a third-line Treatment) for Status Epilepticus (SE) within the first 24 hours after Study Drug Initiation. |
| Secondary | Time to Cessation of SE | Time to SE Cessation, assessed up to 24 hours | Summary of Time to SE Cessation |
| Secondary | Number of Participants Who Required No Escalation of Treatment for Ongoing or Recurrent SE | Drug initiation through follow-up period, up to approximately 4 weeks | Number of participants who Required No Escalation of Treatment for Ongoing or Recurrent SE |
| Secondary | Number of Participants With No SE Recurrence Per Principal Investigator | Baseline (within 24hrs of treatment) through follow up period, up to approximately 4 weeks. | Number of participants with No SE Recurrence per Principal Investigator within 24hrs of starting treatment, during treatment period (excluding taper), during taper, during 24-hr follow-up period, and during follow-up period. |
| Secondary | Seizure Burden | Baseline (Pre-dose) to <-24hrs (Post Dose) | Seizure Burden (%) Baseline and Percentage Change from Baseline by Time Point |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Did Not Require an IV Anesthetic Drug for SE Treatment | 24 hours post study drug initiation | Safety Population: included all participants who received at least one dose of IV ganaxolone (GNX). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Cessation of SE | Time to SE Cessation, assessed up to 24 hours | Safety Population. Only participants were included if seizure was confirmed. | Minutes | MEDIAN |
| SECONDARY | Number of Participants Who Required No Escalation of Treatment for Ongoing or Recurrent SE | Drug initiation through follow-up period, up to approximately 4 weeks | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With No SE Recurrence Per Principal Investigator | Baseline (within 24hrs of treatment) through follow up period, up to approximately 4 weeks. | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Seizure Burden | Baseline (Pre-dose) to <-24hrs (Post Dose) | Safety Population | Percentage change from baseline | MEAN |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Did Not Require an IV Anesthetic Drug for SE Treatment | Low - GNX | 5 | Participants | ||
| Number of Participants Who Did Not Require an IV Anesthetic Drug for SE Treatment | Medium - GNX | 4 | Participants | ||
| Number of Participants Who Did Not Require an IV Anesthetic Drug for SE Treatment | High - GNX | 8 | Participants | ||
| Time to Cessation of SE | Low - GNX | 5.000 | Full Range 2.45 to 6.05 | Minutes | |
| Time to Cessation of SE | Medium - GNX | 5.580 | Full Range 4.18 to 22.25 | Minutes | |
| Time to Cessation of SE | High - GNX | 10.16 | Full Range 1.34 to 241.00 | Minutes | |
| Number of Participants Who Required No Escalation of Treatment for Ongoing or Recurrent SE | Low - GNX | 3 | Participants | ||
| Number of Participants Who Required No Escalation of Treatment for Ongoing or Recurrent SE | Medium - GNX | 3 | Participants | ||
| Number of Participants Who Required No Escalation of Treatment for Ongoing or Recurrent SE | High - GNX | 8 | Participants | ||
| Number of Participants With No SE Recurrence Per Principal Investigator | Low - GNX | Within 24hrs of starting treatment | 5 | Participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low - GNX | 5 | |
| Overall Study | STARTED | Medium - GNX | 4 | |
| Overall Study | STARTED | High - GNX | 8 | |
| Overall Study | COMPLETED | Low - GNX | 3 | |
| Overall Study | COMPLETED | Medium - GNX | 4 | |
| Overall Study | COMPLETED | High - GNX | 7 | |
| Overall Study | NOT COMPLETED | Low - GNX | 2 | |
| Overall Study | NOT COMPLETED | Medium - GNX | 0 | |
| Overall Study | NOT COMPLETED | High - GNX | 1 |
Source ClinicalTrials.gov
Adverse events57
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 | Somnolence | Nervous system disorders | Low - GNX | 1 | 5 | |
| other | Somnolence | Nervous system disorders | Medium - GNX | 1 | 4 | |
| other | Somnolence | Nervous system disorders | High - GNX | 3 | 8 | |
| other | Sedation | Nervous system disorders | Low - GNX | 0 | 5 | |
| other | Sedation | Nervous system disorders | Medium - GNX | 1 | 4 | |
| other | Sedation | Nervous system disorders | High - GNX | 1 | 8 | |
| other | Pain | General disorders | Low - GNX | 1 | 5 | |
| other | Pain | General disorders | Medium - GNX | 1 | 4 | |
| other | Pain | General disorders | High - GNX | 0 | 8 | |
| other | Hypotension | Vascular disorders | Low - GNX | 2 | 5 |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low - GNX | 2 | 5 |
| Total, all-cause mortality | Medium - GNX | 0 | 4 |
| Total, all-cause mortality | High - GNX | 1 | 8 |
| Total, other adverse events | Low - GNX | 5 | 5 |
| Total, other adverse events | Medium - GNX | 3 | 4 |
| Total, other adverse events | High - GNX | 7 | 8 |
| Total, serious adverse events | Low - GNX | 2 | 5 |
| Total, serious adverse events | Medium - GNX | 2 | 4 |
| Total, serious adverse events | High - GNX | 2 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35748707 | DERIVED |
Source PubMed
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/NCT03350035
GET https://conductscience.org/api/trials/v1/NCT03350035/results?page=2