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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has received benzodiazepines before or after arrival to the ED for generalized convulsive seizures lasting more than 5 minutes
Ongoing or recurrent convulsions, or evidence of electrographic SE on rapid EEG immediately prior to the first IP bolus initiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 hours
Awards & highlights
Study Summary
This trial will test the safety and effectiveness of using ganaxolone to treat epilepsy, by adjusting the dose and comparing it to a placebo.
Who is the study for?
Adults over 18 with ongoing or recurrent convulsive seizures lasting more than 5 minutes, who have received benzodiazepines and are about to receive a second-line IV AED. Excluded are those intubated, pregnant, incarcerated, under 40 kg, severely hypotensive on multiple vasopressors, with life expectancy less than 24 hours or certain medical conditions.Check my eligibility
What is being tested?
The trial is testing IV Ganaxolone as an additional treatment for established status epilepticus (ESE). It starts with an open-label phase to find the right dose and then compares it against a placebo in a double-blind setup alongside standard care.See study design
What are the potential side effects?
Potential side effects of IV Ganaxolone may include drowsiness, dizziness, fatigue, headache and potential allergic reactions. Side effects specific to this study haven't been listed but will be monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been given benzodiazepines for seizures lasting over 5 minutes.
Select...
I have ongoing seizures or signs of seizure activity on a recent EEG.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Absence of electrographic (rapid electroencephalography [EEG]) evidence of status epilepticus or recurrence of convulsions at 1 hour after the first IP bolus administration without the use of any additional medications with anti-seizure properties
Secondary outcome measures
Percentage of participants with no escalation of care (including re-administration of IP) at any point within 24 hours from the initial IP bolus administration
Percentage of participants with no escalation of care for Status epilepticus (SE) during investigational product (IP) infusion
Percentage of participants with no escalation to IV anesthesia for treatment of seizures during IP infusion
+3 moreSide effects data
From 2021 Phase 3 trial • 101 Patients • NCT0357293336%
Somnolence
18%
Pyrexia
14%
Seizure
10%
Vomiting
10%
Upper Respiratory Tract Infection
6%
Salivary Hypersecretion
6%
Sedation
6%
Constipation
6%
Rash
6%
Seasonal Allergy
4%
Lethargy
4%
Gait Disturbance
4%
Irritability
4%
Nasal Congestion
4%
Ear Infection
4%
Influenza
4%
Hypersomnia
4%
Bronchitis
4%
Insomnia
4%
Rhinitis
2%
Oxygen Saturation Decreased
2%
Rhinovirus Infection
2%
Urinary Tract Infection
2%
Food Refusal
2%
Pneumonia Aspiration
2%
Diarrhoea
2%
Rhinorrhoea
2%
Respiratory Tract Infection Viral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ganaxolone
Placebo
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Double-blind phase: IV Ganaxolone + SOCExperimental Treatment1 Intervention
Group II: Dose optimization phase (open label): IV Ganaxolone bolus (variable) followed by infusion (variable)Experimental Treatment1 Intervention
Group III: Double-blind phase: IV Placebo + SOCPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Marinus PharmaceuticalsLead Sponsor
22 Previous Clinical Trials
1,843 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need two or more medications to manage my low blood pressure.My seizure is due to a sudden lack of oxygen, heart stoppage, injury, sugar level issues, or eclampsia.I have been given benzodiazepines for seizures lasting over 5 minutes.My kidney function is low, but I am not on dialysis.I am currently on a breathing machine or it has been decided that I will be.I weigh less than 40 kg.I have ongoing seizures or signs of seizure activity on a recent EEG.I am allergic to progesterone or related medications.I have chosen not to participate in this study.I took my last benzodiazepine dose more than 5 minutes ago.I am 18 years old or older.I haven't started a second-line IV treatment for my current seizure episode, or it can be started within specific times around my first treatment.I am currently receiving a treatment that includes Captisol.
Research Study Groups:
This trial has the following groups:- Group 1: Double-blind phase: IV Placebo + SOC
- Group 2: Dose optimization phase (open label): IV Ganaxolone bolus (variable) followed by infusion (variable)
- Group 3: Double-blind phase: IV Ganaxolone + SOC
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 0 awards, including:Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the Ganaxolone bolus a safe method of dose optimization for individuals?
"Dose optimization phase (Open Label): IV Ganaxolone followed by bolus is rated a 2 since there has been evidence of its safety, yet it is still in Phase 2 and therefore efficacy studies are underway."
Answered by AI
Is enrollment still open for this experiment?
"According to the records available on clinicaltrials.gov, this medical study is not accepting applicants at present; however, it was initially posted in January 1st 2026 and most recently edited on February 24th 2023. Fortunately, there are 13 other trials that remain open for enrollment presently."
Answered by AI
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