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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
Sponsor:
Information provided by (Responsible Party):
Marinus Pharmaceuticals

Study Description
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Brief Summary:
This study will evaluate the effectiveness and safety of an investigational product (IP), intravenous (IV) ganaxolone, to treat participants with status epilepticus (SE).

Condition or disease Intervention/treatment Phase
Status Epilepticus Drug: Ganaxolone Drug: Placebo Phase 3

Detailed Description:
This is a double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of IV ganaxolone in status epilepticus. Investigational product will be added to standard of care following failure of any two or more antiseizure medications (benzodiazepine and one IV antiepileptic drug (AED) or two IV AEDs. Participants will be screened for inclusion/exclusion criteria prior to receiving investigational product by continuous IV infusion. Participants will be followed for approximately 4 weeks. Participants who are known to be at risk for SE may be consented or assented prior to an SE event.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Ganaxolone

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: IV Placebo
Placebo bolus dose followed by continuous infusion for 36 hours, followed by 12 hour taper
 Drug: Placebo
Placebo will be administered.
Experimental: IV ganaxolone active
Ganaxolone bolus dose followed by continuous infusion for 36 hours, followed by 12 hour taper
 Drug: Ganaxolone
Ganaxolone will be administered.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Percentage of participants with no progression to IV anesthesia for 36 hours following IP initiation [ Time Frame: Up to 36 hours ]

Secondary Outcome Measures :
  1. Percentage of participants with no progression to IV anesthesia for 72 hours following IP initiation [ Time Frame: Up to 72 hours ]
  2. Time to SE Cessation following IP initiation [ Time Frame: Up to 48 hours ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Male or females 12 years of age and older at the time of the first dose of IP

  3. 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

  4. 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

    • Benzodiazepines,
    • IV Fosphenytoin/phenytoin,
    • IV Valproic acid,
    • IV Levetiracetam,
    • IV Lacosamide,
    • IV Brivaracetam, or
    • IV Phenobarbital
  5. 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

Exclusion Criteria:

  1. Life expectancy of less than 24 hours
  2. 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)
  3. 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.
  4. Clinical condition or advance directive that would NOT permit use of IV anesthesia
  5. Participants known or suspected to be pregnant
  6. Participants with known allergy or sensitivity to progesterone or allopregnanolone medications/supplements
  7. Receiving a concomitant IV product containing Captisol®
  8. Known or suspected hepatic insufficiency or hepatic failure leading to impaired synthetic liver function.
  9. 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
  10. 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Marinus clinicaltrials@marinuspharma.com

Locations
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Sponsors and Collaborators
Marinus Pharmaceuticals
More Information
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Responsible Party: Marinus Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04391569    
Other Study ID Numbers: 1042-SE-3003
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marinus Pharmaceuticals:
Seizure
Status Epilepticus
Convulsive Status Epilepticus
Non-Convulsive Status Epilepticus
Epilepsy
Additional relevant MeSH terms:
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Status Epilepticus
Seizures
Neurologic Manifestations
Nervous System Diseases
Ganaxolone
Neurosteroids
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
GABA Modulators
GABA Agents