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
|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 ]
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