Status EpilepticusPhase 3RAISENCT04391569

Randomized Therapy In Status Epilepticus

A Phase 3 study testing Ganaxolone in people with Status Epilepticus, run by Marinus Pharmaceuticals at 74 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study evaluated the effectiveness and safety of an investigational product (IP), intravenous (IV) ganaxolone, to treat participants with status epilepticus (SE). Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Status Epilepticus
What is being tested?: Ganaxolone
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 74 sitesin 3 countries
Study dates: 9 Dec 2020to 28 Apr 2024
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Participant, participant's parent, guardian, or legal authorized representative (LAR) must provide signed of informed consent/assent, and once capable (per institution guidelines), there must be documentation of consent/assent by the participant demonstrating they are willing and aware of the investigational nature of the study and related procedures. Where allowed by law, where the participant lacks the capacity to make informed decisions regarding his/her medical treatment options, the treating clinician may follow their deferred consenting practices. The clinician will make the final decision based on the best interests of the particiapant.
Male or females 12 years of age and older at the time of the first dose of IP
SE meeting the following criteria:
A diagnosis of SE with or without prominent motor features based on clinical and EEG findings:
Diagnosis is established by:
For SE with prominent motor features: Clinical and EEG seizure activity indicative of convulsive, myoclonic or focal motor SE.

Show all 20Show fewer

For SE without prominent motor features (nonconvulsive SE): Appropriate clinical features and an EEG indicative of non-convulsive status epilepticus (NCSE)
For any type of SE:
At least 6 minutes of cumulative seizure activity over a 30-minute period within the hour before IP initiation, AND
Seizure activity during the 30 minutes immediately prior to IP initiation
The treating clinician(s) anticipate that IV anesthesia is likely to be the next treatment for SE that persists following initiation of IP
Participants must have received any two or more of the following agents for treatment of the current episode of SE administered at an adequate dose and for a sufficient duration, in the judgment of the investigator, to demonstrate efficacy
Benzodiazepines,
IV Fosphenytoin/phenytoin,
IV Valproic acid,
IV Levetiracetam,
IV Lacosamide,
IV Brivaracetam, or
IV Phenobarbital
Body mass index (BMI) < 40 or, if BMI is not able to be calculated at screening, participant is assessed by investigator as not morbidly obese

Who cannot join

Life expectancy of less than 24 hours
Anoxic brain injury or an uncorrected rapidly reversable metabolic condition as the primary cause of SE (e.g., hypoglycemia < 50 milligram per deciliter [mg/dL] or hyperglycemia > 400 mg/dL)
Participants who have received high-dose IV anesthetics (e.g., midazolam, propofol, thiopental, or pentobarbital) during the current episode of SE for more than 18 hours, or who continue to have clinical or electrographic evidence of persistent seizures while receiving high-dose IV anesthetics.
Clinical condition or advance directive that would NOT permit use of IV anesthesia
Participants known or suspected to be pregnant
Participants with known allergy or sensitivity to progesterone or allopregnanolone medications/supplements

Show all 10Show fewer

Receiving a concomitant IV product containing Captisol®
Known or suspected hepatic insufficiency or hepatic failure leading to impaired synthetic liver function.
Known or suspected stage 3B (moderate to severe; estimated glomerular filtration rate [eGFR] 44-30 milliliter/minutes/1.73-meter square [mL/min/1.73m^2]), stage 4 (severe; eGFR 29-15 mL/min/1.73m^2), or stage 5 (kidney failure; eGFR < 15 mL/min/1.73m^2 or dialysis) kidney disease
Use of an investigational product for which less than 30 days or 5 half-lives have elapsed from the final product administration. Participation in a non-interventional clinical study does not exclude eligibility.

Trial locations and contacts

74 sites in 3 countries.

Country

City, postcode or hospital

74 sites in 3 countries

United States64 sites

Marinus Research Site
Albany, New York, 12208
Marinus Research Site
Albuquerque, New Mexico, 87106
Marinus Research Site
Ann Arbor, Michigan, 48109
Marinus Research Site
Aurora, Colorado, 80045
Marinus Research Site #1
Baltimore, Maryland, 21201
Marinus Research Site
Baltimore, Maryland, 21201
Marinus Research Site
Baltimore, Maryland, 21215
Marinus Research Site
Birmingham, Alabama, 35233
Marinus Research Site
Boston, Massachusetts, 02111
Marinus Research Site
Boston, Massachusetts, 02114
Marinus Research Site
Boston, Massachusetts, 02115
Marinus Research Site
Boston, Massachusetts, 02118
Marinus Research Site
Boston, Massachusetts, 02215
Marinus Research Site
Brooklyn, New York, 11203
Marinus Research Site
Chapel Hill, North Carolina, 27514
Marinus Research Site
Charlotte, North Carolina, 28203
Marinus Research Site
Chicago, Illinois, 60611
Marinus Research Site
Chicago, Illinois, 60612
Marinus Research Site
Cincinnati, Ohio, 45219
Marinus Research Site
Cleveland, Ohio, 44195
Marinus Research Site
Columbia, Missouri, 65212
Marinus Research Site
Columbus, Ohio, 43210
Marinus Research Site
Dallas, Texas, 75235
Marinus Research Site
Denver, Colorado, 80204
Marinus Research Site
Downey, California, 90242
Marinus Research Site
Durham, North Carolina, 27710
Marinus Research Site
Fort Worth, Texas, 76104
Marinus Research Site
Gainesville, Florida, 32608
Marinus Research Site
Grand Rapids, Michigan, 49503
Marinus Research Site
Knoxville, Tennessee, 37920
Marinus Research Site
La Jolla, California, 92037
Marinus Research Site
Little Rock, Arkansas, 72205
Marinus Research Site
Louisville, Kentucky, 40202
Marinus Research Site
Madison, Wisconsin, 53792
Marinus Research Site
Memphis, Tennessee, 38103
Marinus Research Site #1
Miami, Florida, 33136
Marinus Research Site
Miami, Florida, 33136
Marinus Research Site
Miami, Florida, 33155
Marinus Research Site
Murray, Utah, 84107
Marinus Research Site
New Brunswick, New Jersey, 08901
Marinus Research Site
New Haven, Connecticut, 06510
Marinus Research Site
New Orleans, Louisiana, 70121
Marinus Research Site
New York, New York, 10029
Marinus Research Site
New York, New York, 10032
Marinus Research Site
Orange, California, 92868
Marinus Research Site #1
Philadelphia, Pennsylvania, 19104
Marinus Research Site #2
Philadelphia, Pennsylvania, 19104
Marinus Research Site
Philadelphia, Pennsylvania, 19104
Marinus Research Site
Philadelphia, Pennsylvania, 19107
Marinus Research Site
Philadelphia, Pennsylvania, 19140
Marinus Research Site
Phoenix, Arizona, 85013
Marinus Research Site
Pittsburgh, Pennsylvania, 15212
Marinus Research Site
Port Saint Lucie, Florida, 34987
Marinus Research Site
Portland, Oregon, 97225
Marinus Research Site
Portland, Oregon, 97239
Marinus Research Site
Richmond, Virginia, 23298
Marinus Research Site
Rochester, New York, 14642
Marinus Research Site
Sacramento, California, 95817
Marinus Research Site
San Antonio, Texas, 78229
Marinus Research Site
Shreveport, Louisiana, 71103
Marinus Research Site
St Louis, Missouri, 63110
Marinus Research Site
Tampa, Florida, 33606
Marinus Research Site
Urbana, Illinois, 61801
Marinus Research Site
Worcester, Massachusetts, 01655

Other trials in United States

Australia5 sites

Marinus Research Site
Box Hill, Victoria, 3128
Marinus Research Site
Melbourne, Victoria, 3004
Marinus Research Site
Melbourne, Victoria, 3050
Marinus Research Site
Randwick, New South Wales, 2031
Marinus Research Site
South Brisbane, Queensland, 4101

Other trials in Australia

Canada5 sites

Marinus Research Site
Calgary, Alberta, T2N 4Z6
Marinus Research Site
Calgary, Alberta, T3B 6A8
Marinus Research Site
Kingston, Ontario, K7L 2V7
Marinus Research Site
Québec, Quebec, G1V 4G2
Marinus Research Site
Saskatoon, Saskatchewan, S7N 0W8

Other trials in Canada

About this study

Official title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous Ganaxolone in Status Epilepticus

This study evaluated the effectiveness and safety of an investigational product (IP), intravenous (IV) ganaxolone, to treat participants with status epilepticus (SE).

Read the detailed description

This is a double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of IV ganaxolone in status epilepticus. Investigational product was added to standard of care following failure of any two or more antiseizure medications (benzodiazepine and one IV antiepileptic drug (AED) or two IV AEDs. Participants were screened for inclusion/exclusion criteria prior to receiving investigational product by continuous IV infusion. Participants were followed for approximately 4 weeks. Participants who are known to be at risk for SE were consented or assented prior to an SE event.

Conditions: Status Epilepticus
Being tested: Ganaxolone, Placebo
Keywords: Seizure, Status Epilepticus, Convulsive Status Epilepticus, Non-Convulsive Status Epilepticus, Epilepsy
Medical subject headings: Status Epilepticus, Seizures, Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GanaxoloneDrug
Ganaxolone will be administered.
PlaceboDrug
Placebo will be administered.

Study groups in NCT04391569
Study group	Role	What they receive
IV Placebo	Placebo comparator	Placebo bolus dose followed by continuous infusion for 36 hours, followed by 12 hour taper Receives: Drug: Placebo
IV ganaxolone active	Experimental	Ganaxolone bolus dose followed by continuous infusion for 36 hours, followed by 12 hour taper Receives: Drug: Ganaxolone

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With SE Cessation Within 30 Minutes of Investigational Product (IP) Initiation Without Medications for the Acute Treatment of SE
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.
Measured: Up to 30 minutes
Percentage of Participants With no Progression to Intravenous (IV) Anesthesia for 36 Hours Following Investigational Product (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.
Measured: Up to 36 hours after IP initiation
Number of Participants With Treatment Emergent Adverse Events
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.
Measured: Up to 4 weeks after IP initiation

Secondary outcomes (7)

Percentage of Participants With no Progression to IV Anesthesia for 72 Hours Following 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.
Measured: Up to 72 hours after IP initiation
Time to SE Cessation Following IP Initiation
Time to SE cessation was assessed for the first 72 hours following IP using the Kaplan-Meier method.
Measured: Up to 72 hours after IP initiation
Percentage of Participants With Any Escalation of Treatment in the First 24 Hours Following 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
Measured: Up to 24 hours after IP initiation
Time to Treatment Escalation in the First 24 Hours Following 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.
Measured: Up to 24 hours after IP initiation
Time to Initiation of Anesthesia for SE Treatment Through the Final Study Follow-up Visit/Contact
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.
Measured: Up to 4 Weeks following IP initiation
Percentage of Participants Who Develop Super Refractory Status Epilepticus (SRSE) Through the Final Study Follow-up Visit/Contact
Percentage of participants who developed SRSE through the final study follow-up visit/contact was provided for each treatment group.
Measured: Up to 4 Weeks following IP initiation
Percent Change From Baseline in Seizure Burden Through 72 Hours Following 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.
Measured: Up to 72 hours after IP initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Dec 202028 Apr 2024

First posted18 May 2020
Study start9 Dec 2020
Primary completion30 Mar 2024
Study completion28 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Status EpilepticusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04391569
Sponsor's protocol ID: 1042-SE-3003
Acronym: RAISE
Status last verified: May 2025
First submitted: 30 Apr 2020
Last updated: 29 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
Stereotypical Prolonged Seizures
Not yet recruitingObservational study
Predictors of Outcomes of Convulsive Status Epilepticus
Status Epilepticus, Convulsive Status Epilepticus
Enrolling by invitationPhase 3
A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
Stereotypical Prolonged Seizures
Recruiting
Acute Effects of Focused Ultrasound Modulation on EEG Behavior in Status Epilepticus Patients
Seizures
RecruitingPhase 3
Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)
Status Epilepticus

All Status Epilepticus trials

Study at a glance

From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous Ganaxolone in Status Epilepticus
ClinicalTrials.gov ID: NCT04391569
Acronym / sponsor ID: RAISE / 1042-SE-3003
Conditions: Status Epilepticus
Keywords: Seizure, Status Epilepticus, Convulsive Status Epilepticus, Non-Convulsive Status Epilepticus, Epilepsy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Marinus PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 9 Dec 2020 (actual)
Primary completion: 30 Mar 2024 (actual)
Study completion: 28 Apr 2024 (actual)
First posted: 18 May 2020 (actual)
Results: Posted 29 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study evaluated the effectiveness and safety of an investigational product (IP), intravenous (IV) ganaxolone, to treat participants with status epilepticus (SE).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
IV Placebo	Placebo comparator	Drug: PlaceboPlacebo bolus dose followed by continuous infusion for 36 hours, followed by 12 hour taper
IV ganaxolone active	Experimental	Drug: GanaxoloneGanaxolone bolus dose followed by continuous infusion for 36 hours, followed by 12 hour taper

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (20 listed)

Participant, participant's parent, guardian, or legal authorized representative (LAR) must provide signed of informed consent/assent, and once capable (per institution guidelines), there must be documentation of consent/assent by the participant demonstrating they are willing and aware of the investigational nature of the study and related procedures. Where allowed by law, where the participant lacks the capacity to make informed decisions regarding his/her medical treatment options, the treating clinician may follow their deferred consenting practices. The clinician will make the final decision based on the best interests of the particiapant.
Male or females 12 years of age and older at the time of the first dose of IP
SE meeting the following criteria:
Participants must have received any two or more of the following agents for treatment of the current episode of SE administered at an adequate dose and for a sufficient duration, in the judgment of the investigator, to demonstrate efficacy
Body mass index (BMI) < 40 or, if BMI is not able to be calculated at screening, participant is assessed by investigator as not morbidly obese

Key exclusion criteria (10 listed)

Life expectancy of less than 24 hours
Anoxic brain injury or an uncorrected rapidly reversable metabolic condition as the primary cause of SE (e.g., hypoglycemia < 50 milligram per deciliter [mg/dL] or hyperglycemia > 400 mg/dL)
Participants who have received high-dose IV anesthetics (e.g., midazolam, propofol, thiopental, or pentobarbital) during the current episode of SE for more than 18 hours, or who continue to have clinical or electrographic evidence of persistent seizures while receiving high-dose IV anesthetics.
Clinical condition or advance directive that would NOT permit use of IV anesthesia
Participants known or suspected to be pregnant

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GanaxoloneGanaxolone will be administered.	Drug	IV ganaxolone active
PlaceboPlacebo will be administered.	Drug	IV Placebo

Primary outcome

Percentage of Participants With SE Cessation Within 30 Minutes of Investigational Product (IP) Initiation Without Medications for the Acute Treatment of SE
Time frame: 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.
Percentage of Participants With no Progression to Intravenous (IV) Anesthesia for 36 Hours Following Investigational Product (IP) Initiation
Time frame: 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.
Number of Participants With Treatment Emergent Adverse Events
Time frame: 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.

7 secondary outcomes

Percentage of Participants With no Progression to IV Anesthesia for 72 Hours Following IP Initiation
Time frame: Up to 72 hours after IP initiation
Time to SE Cessation Following IP Initiation
Time frame: Up to 72 hours after IP initiation
Percentage of Participants With Any Escalation of Treatment in the First 24 Hours Following IP Initiation
Time frame: Up to 24 hours after IP initiation
Time to Treatment Escalation in the First 24 Hours Following IP Initiation
Time frame: Up to 24 hours after IP initiation
Time to Initiation of Anesthesia for SE Treatment Through the Final Study Follow-up Visit/Contact
Time frame: Up to 4 Weeks following IP initiation
Percentage of Participants Who Develop Super Refractory Status Epilepticus (SRSE) Through the Final Study Follow-up Visit/Contact
Time frame: Up to 4 Weeks following IP initiation
Percent Change From Baseline in Seizure Burden Through 72 Hours Following IP Initiation
Time frame: Up to 72 hours after IP initiation

Results and safety

Results posted to the registry on 29 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ganaxolone	51	30
Placebo	49	35

Primary outcome: Percentage of Participants With SE Cessation Within 30 Minutes of Investigational Product (IP) Initiation Without Medications for the Acute Treatment of SE

Time frame: Up to 30 minutes. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Ganaxolone n = 49	Placebo n = 47
Value	79.59 (65.657 to 89.755)	12.77 (4.832 to 25.741)

Ganaxolone vs Placebo: p = 0.0000, fixed weight combination test

Population analysed: 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.

Primary outcome: Percentage of Participants With no Progression to Intravenous (IV) Anesthesia for 36 Hours Following Investigational Product (IP) Initiation

Time frame: Up to 36 hours after IP initiation. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Ganaxolone n = 49	Placebo n = 47
Value	63.27 (48.288 to 76.578)	51.06 (36.064 to 65.924)

Ganaxolone vs Placebo: p = 0.1619, fixed weight combination test

Population analysed: ITT population

Primary outcome: Number of Participants With Treatment Emergent Adverse Events

Time frame: Up to 4 weeks after IP initiation. Number. Unit: Participants

Measure	Ganaxolone n = 51	Placebo n = 49
Any TEAE	48	43
Serious TEAEs	19	18
TEAE Leading to study drug discontinuation	1	2
TEAE leading to withdrawal	2	0
TEAE resulting in death	11	11

Population analysed: Safety Population

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 4 Weeks. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	18 of 49 (36.7%)	39 of 49 (79.6%)	11 of 49
Ganaxolone	19 of 51 (37.3%)	43 of 51 (84.3%)	15 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Status Epilepticus

RecruitingPhase 3
A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
Stereotypical Prolonged Seizures
Not yet recruitingObservational study
Predictors of Outcomes of Convulsive Status Epilepticus
Status Epilepticus, Convulsive Status Epilepticus
Enrolling by invitationPhase 3
A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
Stereotypical Prolonged Seizures
Recruiting
Acute Effects of Focused Ultrasound Modulation on EEG Behavior in Status Epilepticus Patients
Seizures
RecruitingPhase 3
Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)
Status Epilepticus

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

74 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ganaxolone in people with Status Epilepticus, run by Marinus Pharmaceuticals at 74 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With SE Cessation Within 30 Minutes of Investigational Product (IP) Initiation Without Medications for the Acute Treatment of SE (time frame: Up to 30 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04391569.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.