A Phase 2 interventional study of IV Ganaxolone active and IV Placebo, non-active in Status Epilepticus, Convulsive Status EPILEPTICUS and Non Convulsive Status Epilepticus, sponsored by Marinus Pharmaceuticals. Completed at 8 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2023-03-09.
Sponsored by Marinus Pharmaceuticals (part of Immedica Pharma) · Phase 2, Interventional, and Treatment
Among 41 studies in Status Epilepticus with a site in United States — 13 open to participants now, 13 under way, 2 of them phase 3. Status Epilepticus · United States.
Among the 41 studies in Status Epilepticus with a site in United States, this one is the 20th largest by enrollment of the 30 interventional ones that give a count, is one of 4 that started in 2018, is one of 4 in phase 2, and was the 15th registered.
124 studies on the registry are indexed under Status Epilepticus; 37 are open to participants now.
Browse Status Epilepticus studies →13 of the 41 studies in Status Epilepticus with a site in United States are open now. Recruiting first, the newest first:
University of Virginia · Sites in United States
Boston Medical Center · Sites in United States
University of California, San Francisco · Sites in United States
Nationwide Children's Hospital · Sites in United States
University of California, San Francisco · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 29 Status Epilepticus studies recruiting now, 16 (55%) set no upper age limit and 8 (28%) stop at 75 or younger; 14 take children under 18; 2 take healthy volunteers.
This study: 12 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
41 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 8 · Phase 3 11 · Phase 4 2
First in 2005; this study’s year is marked. 4 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 17 is below the median of 80 across 75 interventional studies indexed under Status Epilepticus.
Median enrollment 35 across the 30 interventional studies, 300 across the 11 observational. Of the 26 that completed or were terminated, 12 (46%) have results posted.
This tab as a report to print or save as PDF → With an account.
8 of 41 have an industry lead sponsor. The 10 most frequent:
Marinus Pharmaceuticals is the lead sponsor of 22 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 9 (100%) have results posted.
Marinus Pharmaceuticals has 4 studies filed under Status Epilepticus — fewer than ten, so there is no comparison to draw.
5 of the studies in Status Epilepticus with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06564662Children's Hospital at MontefioreRapid-Response EEG in Children With Suspected Status Epilepticus | 2026-12-08 |
| NCT06194747Nationwide Children's HospitalImproving Status Epilepticus Treatment Times | 2027-03-31 |
| NCT06401707University of California, San FranciscoPeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest | 2027-05-20 |
| NCT07177235Thomas Jefferson UniversityKetamine for the Treatment of Refractory Status Epilepticus | 2027-07 |
| NCT05851391University of California, San FranciscobuRst-supprESsion TO Stop Refractory Status Epilepticus Post-cardiac Arrest | 2027-11-30 |
Among the 41 studies in Status Epilepticus with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study will evaluate the effectiveness and safety of an investigational drug, IV ganaxolone, as adjunctive therapy to standard of care to treat subjects with status epilepticus.
This is a double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, and efficacy of adjunctive IV ganaxolone in subjects with SE.
Study drug will be added to standard of care before IV anesthetic during the treatment of SE.
Subjects will be screened for inclusion/exclusion criteria prior to receiving study drug as adjunctive therapy by continuous IV. Subject's will be followed up for 3 weeks post-treatment.
Subjects who are known to be at risk for SE may be consented and/or assented prior to an SE event.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ganaxolone IV loading dose with continuous infusion (maintenance dose) for 2-4 days followed by an 18-hour taper.
Drug: IV Ganaxolone active
Placebo IV loading dose with continuous infusion (maintenance dose) for 2-4 days followed by an 18-hour taper.
Drug: IV Placebo, non-active
IV
IV
Number of Participants Who Did Not Require an IV Anesthetic Drug for SE Treatment
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.
Time frame: 24 hours post study drug initiation
Time to Cessation of SE
Summary of Time to SE Cessation
Time frame: Time to SE Cessation, assessed up to 24 hours
Number of Participants Who Required No Escalation of Treatment for Ongoing or Recurrent SE
Number of participants who Required No Escalation of Treatment for Ongoing or Recurrent SE
Time frame: Drug initiation through follow-up period, up to approximately 4 weeks
Number of Participants With No SE Recurrence Per Principal Investigator
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.
Time frame: Baseline (within 24hrs of treatment) through follow up period, up to approximately 4 weeks.
Seizure Burden
Seizure Burden (%) Baseline and Percentage Change from Baseline by Time Point
Time frame: Baseline (Pre-dose) to <-24hrs (Post Dose)
| Milestone | Low - GNX | Medium - GNX | High - GNX |
|---|---|---|---|
| Started | 5 | 4 | 8 |
| Completed | 3 | 4 | 7 |
| Not completed | 2 | 0 | 1 |
| Withdrew: Lack of efficacy | 2 | 0 | 0 |
| Withdrew: Subject discharged to hospice | 0 | 0 | 1 |
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.
| Participants | Low - GNX | Medium - GNX | High - GNX |
|---|---|---|---|
| Number of Participants Who Did Not Require an IV Anesthetic Drug for SE Treatment | 5 | 4 | 8 |
Summary of Time to SE Cessation
| Minutes | Low - GNX | Medium - GNX | High - GNX |
|---|---|---|---|
| Time to Cessation of SE | 5.000 (2.45 to 6.05) | 5.580 (4.18 to 22.25) | 10.16 (1.34 to 241.00) |
Number of participants who Required No Escalation of Treatment for Ongoing or Recurrent SE
| Participants | Low - GNX | Medium - GNX | High - GNX |
|---|---|---|---|
| Number of Participants Who Required No Escalation of Treatment for Ongoing or Recurrent SE | 3 | 3 | 8 |
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.
| Participants | Low - GNX | Medium - GNX | High - GNX |
|---|---|---|---|
| Within 24hrs of starting treatment | 5 | 4 | 7 |
| During treatment period (excluding taper) | 3 | 4 | 7 |
| During taper | 3 | 2 | 7 |
| During 24-hr follow-up period | 3 | 3 | 8 |
| During follow-up period | 1 | 3 | 7 |
Seizure Burden (%) Baseline and Percentage Change from Baseline by Time Point
| Percentage change from baseline | Low - GNX | Medium - GNX | High - GNX |
|---|---|---|---|
| Change from Baseline at 0 to <- 1 Hour Post-Dose | -94.80 ± 8.458 | -74.63 ± 25.247 | -84.01 ± 18.862 |
| Change from Baseline at 0 to <- 4 Hour Post-Dose | -98.59 ± 2.092 | -71.75 ± 33.498 | -87.99 ± 21.439 |
| Change from Baseline at >4 to <- 8 Hours Post-Dose | -77.53 ± 17.950 | -59.80 ± 48.352 | -96.58 ± 6.772 |
| Change from Baseline at >8 to <- 16 Hours Post-Dose | -47.98 ± 38.063 | -53.29 ± 44.490 | -93.75 ± 13.306 |
| Change from Baseline at >16 to <- 24 Hours Post-Dose | -99.53 ± 0.935 | -48.25 ± 45.475 | -81.16 ± 47.368 |
| Change from Baseline at 0 to <- 24 Hours Post-Dose | -78.64 ± 15.286 | -56.10 ± 42.183 | -89.06 ± 20.039 |
Collected over Baseline (within 24hrs of treatment) through follow up period, up to approximately 4 weeks. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Low - GNX | 2/5 (40%) | 2/5 (40%) | 5/5 (100%) |
| Medium - GNX | 0/4 (0%) | 2/4 (50%) | 3/4 (75%) |
| High - GNX | 1/8 (12.5%) | 2/8 (25%) | 7/8 (87.5%) |
| Event | Low - GNX | Medium - GNX | High - GNX |
|---|---|---|---|
| SedationNervous system disorders | 0/5 | 1/4 | 1/8 |
| Loss of consciousnessNervous system disorders | 0/5 | 1/4 | 0/8 |
| FallInjury, poisoning and procedural complications | 0/5 | 1/4 | 1/8 |
| Multiple fracturesInjury, poisoning and procedural complications | 0/5 | 1/4 | 0/8 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 0/5 | 1/4 | 0/8 |
| SepsisInfections and infestations | 1/5 | 0/4 | 0/8 |
| Endotracheal intubationSurgical and medical procedures | 1/5 | 0/4 | 0/8 |
| Withdrawal of life supportSurgical and medical procedures | 1/5 | 0/4 | 0/8 |
| Intestinal perforationGastrointestinal disorders | 0/5 | 0/4 | 1/8 |
| Event | Low - GNX | Medium - GNX | High - GNX |
|---|---|---|---|
| HypotensionVascular disorders | 2/5 | 0/4 | 2/8 |
| SomnolenceNervous system disorders | 1/5 | 1/4 | 3/8 |
| SedationNervous system disorders | 0/5 | 1/4 | 1/8 |
| PainGeneral disorders | 1/5 | 1/4 | 0/8 |
| LeukocytosisBlood and lymphatic system disorders | 0/5 | 0/4 | 2/8 |
| HypokalaemiaMetabolism and nutrition disorders | 0/5 | 1/4 | 2/8 |
| HypocalcaemiaMetabolism and nutrition disorders | 0/5 | 0/4 | 2/8 |
| HypercaprniaRespiratory, thoracic and mediastinal disorders | 0/5 | 0/4 | 2/8 |
| PneumoniaInfections and infestations | 0/5 | 1/4 | 1/8 |
| HaematuriaRenal and urinary disorders | 1/5 | 0/4 | 1/8 |
Safety Population
| Age, Continuous(years) | Low - GNX | Medium - GNX | High - GNX | Total |
|---|---|---|---|---|
| Mean | 57.8 ± 25.35 | 62.0 ± 18.96 | 53.8 ± 17.04 | 56.9 ± 19.15 |
| Sex: Female, Male(Participants) | Low - GNX | Medium - GNX | High - GNX | Total |
|---|---|---|---|---|
| Female | 5 | 2 | 2 | 9 |
| Male | 0 | 2 | 6 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Low - GNX | Medium - GNX | High - GNX | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 5 | 4 | 6 | 15 |
| Unknown or Not Reported | 0 | 0 | 2 | 2 |
| Race (NIH/OMB)(Participants) | Low - GNX | Medium - GNX | High - GNX | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 2 | 5 |
| White | 3 | 2 | 4 | 9 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 2 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Feb 2018 to primary completion in Sep 2019, 18 months.
Results were first posted in Dec 2022, 3 years 2 months after primary completion. A results delay was requested in Sep 2020.
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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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