Randomized Therapy In Status Epilepticus (RAISE)
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|ClinicalTrials.gov Identifier: NCT04391569|
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : February 23, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Status Epilepticus||Drug: Ganaxolone Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous Ganaxolone in Status Epilepticus|
|Actual Study Start Date :||October 10, 2020|
|Estimated Primary Completion Date :||October 31, 2023|
|Estimated Study Completion Date :||October 31, 2023|
Placebo Comparator: IV Placebo
Placebo bolus dose followed by continuous infusion for 36 hours, followed by 12 hour taper
Placebo will be administered.
Experimental: IV ganaxolone active
Ganaxolone bolus dose followed by continuous infusion for 36 hours, followed by 12 hour taper
Ganaxolone will be administered.
- Percentage of participants reporting SE cessation within 30 minutes of IP initiation without medications for the acute treatment of SE [ Time Frame: Up to 30 minutes ]SE cessation will be determined by the investigator based on clinical and electroencephalography (EEG). Medications for the acute treatment of SE are defined as 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 IV anesthesia for 36 hours following IP initiation [ Time Frame: Up to 36 hours ]
- Percentage of participants with no progression to IV anesthesia for 72 hours following IP initiation [ Time Frame: Up to 72 hours ]
- Time to SE Cessation following IP initiation [ Time Frame: Up to 48 hours ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||12 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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. A diagnosis of SE with or without prominent motor features based on clinical and EEG findings:
i. Diagnosis is established by:
- For SE with prominent motor features: Clinical and EEG seizure activity indicative of convulsive, myoclonic or focal motor SE.
- For SE without prominent motor features (nonconvulsive SE): Appropriate clinical features and an EEG indicative of non-convulsive status epilepticus (NCSE)
ii. 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
b. 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
- 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
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04391569
|Responsible Party:||Marinus Pharmaceuticals|
|Other Study ID Numbers:||
|First Posted:||May 18, 2020 Key Record Dates|
|Last Update Posted:||February 23, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Convulsive Status Epilepticus
Non-Convulsive Status Epilepticus
Nervous System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs