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Ganaxolone for Epileptic Seizure

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Epileptic Seizure+3 MoreGanaxolone - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

This trial will test if the investigational product ganaxolone can treat subjects with epilepsy who are experiencing seizures.

Eligible Conditions
  • Epileptic Seizure
  • Non-Convulsive Status Epilepticus
  • Status Epilepticus (Convulsive)
  • Epilepsy

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

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1
Isradipine
1
IP

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: 72 hours

48 hours
SE Cessation
72 hours
Progression to IV anesthesia
Up to 30 minutes
Percentage of participants reporting SE cessation within 30 minutes of IP initiation without medications for the acute treatment of SE
Up to 36 hours
Percentage of participants with no progression to IV anesthesia for 36 hours following IP initiation
Up to 48 hours
Time to SE Cessation following IP initiation
Up to 72 hours
Percentage of participants with no progression to IV anesthesia for 72 hours following IP initiation

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
MDMA
1
Isradipine
1
IP

Side Effects for

Ganaxolone
19%Somnolence
14%Headache
8%Sedation
8%Fatigue
7%Dizziness
7%Myalgia
7%Vision blurred
7%Nightmare
5%Dysarthria
5%Confusional state
3%Vertigo
3%Diarrhoea
3%Balance disorder
3%Gastrointestinal disorder
3%Nasopharyngitis
3%Cough
3%Neck pain
3%Pain in extremity
3%Lethargy
3%Tremor
3%Insomnia
3%Ataxia
3%Increased appetite
2%Arthralgia
2%Nausea
2%Dry mouth
2%Feeling drunk
2%Product used for unknown indication
2%Euphoric mood
2%Tic
2%Upper respiratory tract infection
2%Rhinorrhoea
2%Chest discomfort
2%Psychomotor retardation
2%Vomiting
2%Disturbance in attention
2%Balance Issues
2%Chest pain
2%Irritability
2%Urinary tract infection
2%Decreased appetite
2%Back pain
2%Splenomegaly
2%Abdominal discomfort
2%Haematuria
2%Sinus congestion
2%Upper airway resistance syndrome
2%Suicidal Ideation
2%Fever
2%Dry Eye
2%Pharyngitis streptococcal
2%Pulmonary congestion
2%Alanine aminotransferase increased
2%Blood urine present
2%Liver function test abnormal
2%Protein urine present
2%Tandem galt test abnormal
2%Muscle spasms
2%Migraine
2%Motor dysfunction
2%Abnormal dreams
2%Anger
2%Anorgasmia
2%Depressed
2%Initial insomnia
2%Sleep disorder
2%Suicidal ideation
2%Rash
2%Suicide of companion
2%Depressed level of consciousness
2%Confusion
2%Road traffic accident
2%Weight increased
This histogram enumerates side effects from a completed 2014 Phase 2 trial (NCT01339689) in the Ganaxolone ARM group. Side effects include: Somnolence with 19%, Headache with 14%, Sedation with 8%, Fatigue with 8%, Dizziness with 7%.

Trial Design

2 Treatment Groups

IV ganaxolone active
1 of 2
IV Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

124 Total Participants · 2 Treatment Groups

Primary Treatment: Ganaxolone · Has Placebo Group · Phase 3

IV ganaxolone active
Drug
Experimental Group · 1 Intervention: Ganaxolone · Intervention Types: Drug
IV Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ganaxolone
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 72 hours

Who is running the clinical trial?

Marinus PharmaceuticalsLead Sponsor
20 Previous Clinical Trials
1,720 Total Patients Enrolled
Maciej Gasior, MD, PhDStudy DirectorMarinus Pharmaceuticals, Inc.
1 Previous Clinical Trials
17 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Participants, their parents, guardians or LARs must provide a signed document indicating consent/assent and in instances where the participant is judged to be incapable of making informed decisions about medical treatment (as determined by institution guidelines) deferred practices may be followed
You are male or female and at least 12 years old when you received the initial dose of IP.
Clinical and EEG evidence of convulsive, myoclonic or focal motor SE must be present for those exhibiting prominent motor features.
You exhibit the necessary clinical characteristics and an electroencephalogram (EEG) showing signs of NCSE.
You experienced a minimum of 6 minutes of seizure activity within the hour prior to starting IP.
You experienced no seizure activity in the preceding half hour.
The treating physician(s) presume that intravenous anesthesia is likely to be the following remedy for status epilepticus persisting after initiating intramuscular treatment.
To be eligible, you must have received two or more of the specified treatments for your episode of SE at a dose and duration deemed appropriate by the investigator to show efficacy.
You are using benzodiazepines.
You have received intravenous fosphenytoin or phenytoin.
References

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