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Neurosteroid
Ganaxolone for Epileptic Seizure (RAISE Trial)
Phase 3
Recruiting
Research Sponsored by Marinus Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 72 hours
Awards & highlights
RAISE Trial Summary
This trial will test if the investigational product ganaxolone can treat subjects with epilepsy who are experiencing seizures.
RAISE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 72 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 72 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants reporting SE cessation within 30 minutes of IP initiation without medications for the acute treatment of SE
Percentage of participants with no progression to IV anesthesia for 36 hours following IP initiation
Secondary outcome measures
Percentage of participants with no progression to IV anesthesia for 72 hours following IP initiation
Time to SE Cessation following IP initiation
Side effects data
From 2014 Phase 2 trial • 112 Patients • NCT0133968919%
Somnolence
14%
Headache
8%
Fatigue
8%
Sedation
7%
Dizziness
7%
Nightmare
7%
Vision blurred
7%
Myalgia
5%
Confusional state
5%
Dysarthria
3%
Vertigo
3%
Pain in extremity
3%
Gastrointestinal disorder
3%
Tremor
3%
Neck pain
3%
Nasopharyngitis
3%
Increased appetite
3%
Ataxia
3%
Balance disorder
3%
Cough
3%
Insomnia
3%
Diarrhoea
3%
Lethargy
2%
Road traffic accident
2%
Pulmonary congestion
2%
Splenomegaly
2%
Upper respiratory tract infection
2%
Dry mouth
2%
Confusion
2%
Arthralgia
2%
Balance Issues
2%
Tandem galt test abnormal
2%
Rhinorrhoea
2%
Urinary tract infection
2%
Protein urine present
2%
Vomiting
2%
Chest pain
2%
Decreased appetite
2%
Abnormal dreams
2%
Nausea
2%
Chest discomfort
2%
Feeling drunk
2%
Irritability
2%
Pharyngitis streptococcal
2%
Blood urine present
2%
Weight increased
2%
Back pain
2%
Muscle spasms
2%
Depressed level of consciousness
2%
Disturbance in attention
2%
Motor dysfunction
2%
Anger
2%
Depressed
2%
Euphoric mood
2%
Initial insomnia
2%
Psychomotor retardation
2%
Sleep disorder
2%
Upper airway resistance syndrome
2%
Anorgasmia
2%
Suicidal ideation
2%
Haematuria
2%
Suicide of companion
2%
Product used for unknown indication
2%
Dry Eye
2%
Abdominal discomfort
2%
Alanine aminotransferase increased
2%
Liver function test abnormal
2%
Tic
2%
Migraine
2%
Suicidal Ideation
2%
Fever
2%
Sinus congestion
2%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ganaxolone
Placebo
RAISE Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: IV ganaxolone activeExperimental Treatment1 Intervention
Ganaxolone bolus dose followed by continuous infusion for 36 hours, followed by 12 hour taper
Group II: IV PlaceboPlacebo Group1 Intervention
Placebo bolus dose followed by continuous infusion for 36 hours, followed by 12 hour taper
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ganaxolone
FDA approved
Find a Location
Who is running the clinical trial?
Marinus PharmaceuticalsLead Sponsor
22 Previous Clinical Trials
1,839 Total Patients Enrolled
Maciej Gasior, MD, PhDStudy DirectorMarinus Pharmaceuticals, Inc.
1 Previous Clinical Trials
17 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently receiving intravenous (IV) lacosamide.I'm sorry, but the provided criterion is incomplete. Can you please provide more specific information or context for this criterion?You had a seizure within 30 minutes before starting the study medication.You are allergic or sensitive to progesterone or allopregnanolone medications/supplements.You are currently receiving another medicine through an IV that contains Captisol®.It seems like there is missing information in the criterion you provided. Could you please provide more details or clarify what "SE" refers to?The doctor thinks that if the initial treatment doesn't work, you may need to receive anesthesia through a vein (IV) for further treatment.I'm sorry, it seems part of the criterion you provided is missing. Could you please provide the complete criterion?Doctors believe you have less than 24 hours to live.
Research Study Groups:
This trial has the following groups:- Group 1: IV Placebo
- Group 2: IV ganaxolone active
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
When will Ganaxolone likely be cleared by the FDA?
"There is both efficacy and safety data available for Ganaxolone because it is a Phase 3 trial, so it received a score of 3."
Answered by AI
How many people are being monitored as part of this research?
"That is correct. The clinicaltrials.gov website contains information which supports that this study is recruiting patients. This study was first posted on 10/10/2020 and was last edited on 10/20/2022. The study is looking for 124 participants between 54 sites."
Answered by AI
Are there any other Ganaxolone trials that we can compare this one to?
"There is currently one trial underway for Ganaxolone, which is in Phase 3. Although the primary research site for Ganaxolone is Little Rock, Arkansas, there are 54 other locations across the United States conducting research for this medication."
Answered by AI
Is this investigation an original one?
"Presently, there is a single ongoing Ganaxolone trial spanning 54 cities in a single nation. The inaugural Ganaxolone clinical trial was in 2020 and, upon completion of its Phase 3 drug approval process, involved 124 study participants. Since then, 18,247 more trials have been completed."
Answered by AI
Are there any more spots open for this research project?
"The listed clinical trial on clinicaltrials.gov is searching for participants, with the last update to the posting on 10/20/2022. The trial was first advertised on 10/10/2020."
Answered by AI
Who else is applying?
What site did they apply to?
Marinus Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
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