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To Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus (RSE)

Primary Purpose

Refractory Status Epilepticus

Status
Not yet recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ganaxolone
Placebo
Standard of care
Sponsored by
Marinus Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Status Epilepticus focused on measuring Refractory status epilepticus, Ganaxolone, Antiepileptic drug, Standard of care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participant, participant's parent, guardian, or LAR must provide signed 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 participant. Male or females 18 years of age and older at the time of the first dose of IP. SE warranting imminent progression of treatment meeting the following criteria: a) A diagnosis of SE, warranting imminent progression of treatment for seizure control, 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. Participants must have received a benzodiazepine and at least 1 of the following IV AEDs for treatment of the current episode of SE administered at an adequate dose and for a sufficient duration, in the judgement of the investigator, to demonstrate efficacy. The benzodiazepine and at least 1 of the IV AEDs must have been administered at a dose that would be expected to be effective for the termination of the current episode of SE. 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. Exclusion Criteria: Life expectancy of less than 24 hours. Anoxic brain injury or an uncorrected, rapidly reversable metabolic condition as the primary cause of SE (eg, hypoglycemia < 50 milligrams per deciliter [mg/dL] or hyperglycemia > 400 mg/dL). Participants who have received high-dose IV anesthetics (eg, 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 admission to the ICU or 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 milliliters per minute per 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. Known or suspected history or evidence of a medical condition that, in the investigator's judgment, would expose a participant to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the study

Sites / Locations

  • Kepler University Hospital
  • Paracelsus Medical University Salzburg, Christian Doppler University Hospital, Department of Neurology
  • Medical University Vienna
  • Hôpital Universitaire de Bruxelles - Hôpital Erasme
  • UZA University Hospital Antwerpen
  • University Hospitals UZ Leuven
  • University Hospital Centre Zagreb
  • Dubrava University Hospital
  • Mazaryk University, Brno,The First Department of Neurology
  • University Hospital Ostrava
  • Motol University Hospital
  • University Hospital Righospitalet
  • Helsinki University Hospital
  • Kuopio University Hospital
  • Hopital R. Salengro
  • Hospices Civils de Lyon
  • CHRU Nancy
  • Chu de Toulouse
  • Universitätsklinikum Erlangen
  • Epilepsy Center Hessen
  • University of Osnabruck, Dep of Neurology, Osnabrück
  • Universität- und Rehabilitationskliniken Ulm, RKU
  • National Institute of Clinical Neurosciences
  • Hadassah Medical Center
  • Tel-Aviv Sourasky Medical Center
  • Sheba Medical Center
  • Università Cattolica del Sacro Cuore
  • Azienda Ospedaliera Universitaria di Modena
  • Azienda Ospedaliera Universitaria Integrata di Verona
  • Vilnius University Hospital Santaros Klinikos
  • Uniwersyteckie Centrum Kliniczne
  • Hospital Universitari Vall d'Hebron
  • Hospital Clinico San Carlos
  • Centre Hospitalier Universitaire Vaudois (CHUV)
  • Oxford University Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ganaxolone IV solution + SOC IV AED

Placebo IV solution + SOC IV AED

Arm Description

Outcomes

Primary Outcome Measures

Percentage of participants who will report cessation of SE within 30 minutes of investigational product (IP) initiation of at least 30 minutes duration
Status epilepticus cessation will be determined by the investigator based on clinical and electroencephalography (EEG) features
Percentage of participants who will report no escalation of treatment for persistent or recurrent SE within 36 hours of IP initiation

Secondary Outcome Measures

Percentage of participants who will report cessation of SE within 30 minutes of IP initiation of at least 30 minutes duration
Percentage of participants who will report no escalation of treatment for persistent or recurrent SE within 72 hours of IP initiation
Time to SE cessation
Percentage of participants having cessation of SE within 30 minutes of IP initiation of at least 30 minutes duration without escalation of treatment
Percentage of participants reporting no escalation of treatment for persistent or recurrent SE within 36 hours of IP initiation
Percentage of participants reporting no escalation of treatment for persistent or recurrent SE within 72 hours of IP initiation
Change from Baseline in Modified Rankin Scale (mRS) at the time of hospital discharge
The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death where 0 - No symptoms; 1=No significant disability. Able to carry out all usual activities, despite some symptoms; 2=Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities; 3=Moderate disability. Requires some help, but able to walk unassisted; 4=Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted; 5=Severe disability. Requires constant nursing care and attention, bedridden, incontinent; 6=Dead. Higher scores will indicate high degree of disability.
Change from Baseline in level of responsiveness as assessed by the Full Outline of UnResponsiveness (FOUR) Score scale
The FOUR Score is a 17-point scale (with potential scores ranging from 0 - 16). Decreasing FOUR Score is associated with worsening level of consciousness. The FOUR coma scale includes 4 parameters with a minimum score of 0 and a maximum score of "4" for each of them: eye reactions (eye opening and tracking), motor responses (pain response and simple commands), stem reflexes (pupillary, corneal and cough) and respiratory patterns (respiratory rhythm and respiratory attempts in patients on a ventilator). The points are summed up, their sum is estimated. The interpretation of results will be as 15 to 16 score: clear consciousness; Less than 15: Impairment of consciousness; from 4 to 8: Coma and 0-4: Death. Lower the score, the greater the coma gravity.
Change from Baseline in level of sedation/ agitation as assessed by Richmond Agitation and Sedation Scale (RASS)
The RASS is a medical scale used to measure the agitation or sedation level. It is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm. higher scores indicate more agitation.
Percentage of participants with mRS > 3 at the time of hospital discharge
The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death where 0 - No symptoms; 1=No significant disability. Able to carry out all usual activities, despite some symptoms. 2=Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3=Moderate disability. Requires some help, but able to walk unassisted. 4=Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5=Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6=Dead. Higher scores will indicate high degree of disability.
Change from Baseline in Clinical Global Impression-Improvement (CGI-I) following IP initiation and at hospital discharge
The CGI-I is a 7-point Likert scale that the parent(s)/caregiver(s)/legally authorized representative (LAR)(s) and clinician uses to rate the change in overall seizure control, behavior, safety, and tolerability after initiation of the IP relative to Baseline (prior to treatment with the IP). It was rated as: 1- "very much improved", 2- "much improved', 3- "minimally improved", 4- "no change", 5- "minimally worse", 6- "much worse", and 7- "very much worse". Higher scores indicated worse condition.
Number of hours on positive pressure ventilation attributable to the episode of SE or its treatment
Healthcare Utilization Questionnaires include the Hospitalization Questionnaire and the Positive Pressure Ventilation (PPV) and Intubation Questionnaire. The Hospitalization Questionnaire should be collected at hospital discharge or at final study visit/contact. The need for non-invasive or invasive ventilatory support within 24 hours prior to IP initiation and following IP initiation and within 48 hours following IP discontinuation should be collected as close as possible to the event.
Number of hours on positive pressure ventilation
Length of stay (days) in intensive care unit (ICU)
Length of stay (days) in hospital
Percentage of participants requiring artificial ventilation after initiation of IP
Percentage of participants not requiring IV anesthesia for SE treatment within 36 hours of IP initiation
Percentage of participants not requiring IV anesthesia for SE treatment within 72 hours of IP initiation
Percentage of participants not requiring IV anesthesia for SE treatment through the final study follow-up visit/contact
Percentage of participants who do not develop super refractory status epilepticus (SRSE) through the final study follow-up visit/contact
Change from Baseline in Euro Quality of Life (five-level EuroQoL five-dimensional [EQ-5D-5L]) score
The EQ-5D-5L is the EuroQoL 5D-5L, a descriptive system that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the participant's health state. A positive score means quality of life improvement, a negative score, a worsening of quality of life. Higher scores indicate more problems.
Number of AEDs at discharge
Percentage of participants requiring supplemental oxygen after initiation of IP

Full Information

First Posted
April 3, 2023
Last Updated
September 14, 2023
Sponsor
Marinus Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05814523
Brief Title
To Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus (RSE)
Official Title
A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marinus Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a multicenter, double-blind, randomized, placebo-controlled study that will evaluate the efficacy, safety, and tolerability of intravenous (IV) ganaxolone versus placebo co-administered with IV antiepileptic drug (AED) according to standard of care for the treatment of RSE. Approximately 70 participants will be randomized in a 1:1 ratio to receive ganaxolone IV solution or placebo IV solution along with standard of care (SOC) IV AED.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Status Epilepticus
Keywords
Refractory status epilepticus, Ganaxolone, Antiepileptic drug, Standard of care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ganaxolone IV solution + SOC IV AED
Arm Type
Experimental
Arm Title
Placebo IV solution + SOC IV AED
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ganaxolone
Intervention Description
Ganaxolone will be administered as IV solution.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered as IV solution.
Intervention Type
Drug
Intervention Name(s)
Standard of care
Intervention Description
A non-anesthetic medication not previously used for treatment of SE within the current episode and will be administered at a dose sufficient for the termination of SE according to investigator judgment.
Primary Outcome Measure Information:
Title
Percentage of participants who will report cessation of SE within 30 minutes of investigational product (IP) initiation of at least 30 minutes duration
Description
Status epilepticus cessation will be determined by the investigator based on clinical and electroencephalography (EEG) features
Time Frame
Up to 30 minutes
Title
Percentage of participants who will report no escalation of treatment for persistent or recurrent SE within 36 hours of IP initiation
Time Frame
Up to 36 hours
Secondary Outcome Measure Information:
Title
Percentage of participants who will report cessation of SE within 30 minutes of IP initiation of at least 30 minutes duration
Time Frame
Up to 30 minutes
Title
Percentage of participants who will report no escalation of treatment for persistent or recurrent SE within 72 hours of IP initiation
Time Frame
Up to 72 hours
Title
Time to SE cessation
Time Frame
Up to 72 hours
Title
Percentage of participants having cessation of SE within 30 minutes of IP initiation of at least 30 minutes duration without escalation of treatment
Time Frame
Up to 30 minutes
Title
Percentage of participants reporting no escalation of treatment for persistent or recurrent SE within 36 hours of IP initiation
Time Frame
Up to 36 hours
Title
Percentage of participants reporting no escalation of treatment for persistent or recurrent SE within 72 hours of IP initiation
Time Frame
Up to 72 hours
Title
Change from Baseline in Modified Rankin Scale (mRS) at the time of hospital discharge
Description
The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death where 0 - No symptoms; 1=No significant disability. Able to carry out all usual activities, despite some symptoms; 2=Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities; 3=Moderate disability. Requires some help, but able to walk unassisted; 4=Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted; 5=Severe disability. Requires constant nursing care and attention, bedridden, incontinent; 6=Dead. Higher scores will indicate high degree of disability.
Time Frame
Baseline and Up to Day 31
Title
Change from Baseline in level of responsiveness as assessed by the Full Outline of UnResponsiveness (FOUR) Score scale
Description
The FOUR Score is a 17-point scale (with potential scores ranging from 0 - 16). Decreasing FOUR Score is associated with worsening level of consciousness. The FOUR coma scale includes 4 parameters with a minimum score of 0 and a maximum score of "4" for each of them: eye reactions (eye opening and tracking), motor responses (pain response and simple commands), stem reflexes (pupillary, corneal and cough) and respiratory patterns (respiratory rhythm and respiratory attempts in patients on a ventilator). The points are summed up, their sum is estimated. The interpretation of results will be as 15 to 16 score: clear consciousness; Less than 15: Impairment of consciousness; from 4 to 8: Coma and 0-4: Death. Lower the score, the greater the coma gravity.
Time Frame
Baseline and at 24, 36 and 72 hours
Title
Change from Baseline in level of sedation/ agitation as assessed by Richmond Agitation and Sedation Scale (RASS)
Description
The RASS is a medical scale used to measure the agitation or sedation level. It is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm. higher scores indicate more agitation.
Time Frame
Baseline and at 24, 36 and 72 hours
Title
Percentage of participants with mRS > 3 at the time of hospital discharge
Description
The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death where 0 - No symptoms; 1=No significant disability. Able to carry out all usual activities, despite some symptoms. 2=Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3=Moderate disability. Requires some help, but able to walk unassisted. 4=Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5=Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6=Dead. Higher scores will indicate high degree of disability.
Time Frame
Up to 122 hours
Title
Change from Baseline in Clinical Global Impression-Improvement (CGI-I) following IP initiation and at hospital discharge
Description
The CGI-I is a 7-point Likert scale that the parent(s)/caregiver(s)/legally authorized representative (LAR)(s) and clinician uses to rate the change in overall seizure control, behavior, safety, and tolerability after initiation of the IP relative to Baseline (prior to treatment with the IP). It was rated as: 1- "very much improved", 2- "much improved', 3- "minimally improved", 4- "no change", 5- "minimally worse", 6- "much worse", and 7- "very much worse". Higher scores indicated worse condition.
Time Frame
Baseline and at 24, 36, and 72 hours
Title
Number of hours on positive pressure ventilation attributable to the episode of SE or its treatment
Description
Healthcare Utilization Questionnaires include the Hospitalization Questionnaire and the Positive Pressure Ventilation (PPV) and Intubation Questionnaire. The Hospitalization Questionnaire should be collected at hospital discharge or at final study visit/contact. The need for non-invasive or invasive ventilatory support within 24 hours prior to IP initiation and following IP initiation and within 48 hours following IP discontinuation should be collected as close as possible to the event.
Time Frame
Up to 4 Weeks
Title
Number of hours on positive pressure ventilation
Time Frame
Up to 4 Weeks
Title
Length of stay (days) in intensive care unit (ICU)
Time Frame
Up to 4 Weeks
Title
Length of stay (days) in hospital
Time Frame
Up to 4 Weeks
Title
Percentage of participants requiring artificial ventilation after initiation of IP
Time Frame
Up to 122 hours
Title
Percentage of participants not requiring IV anesthesia for SE treatment within 36 hours of IP initiation
Time Frame
Up to 36 hours
Title
Percentage of participants not requiring IV anesthesia for SE treatment within 72 hours of IP initiation
Time Frame
Up to 72 hours
Title
Percentage of participants not requiring IV anesthesia for SE treatment through the final study follow-up visit/contact
Time Frame
Up to 4 Weeks
Title
Percentage of participants who do not develop super refractory status epilepticus (SRSE) through the final study follow-up visit/contact
Time Frame
Up to 4 Weeks
Title
Change from Baseline in Euro Quality of Life (five-level EuroQoL five-dimensional [EQ-5D-5L]) score
Description
The EQ-5D-5L is the EuroQoL 5D-5L, a descriptive system that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the participant's health state. A positive score means quality of life improvement, a negative score, a worsening of quality of life. Higher scores indicate more problems.
Time Frame
Baseline and Up to 4 Weeks
Title
Number of AEDs at discharge
Time Frame
Up to 122 hours
Title
Percentage of participants requiring supplemental oxygen after initiation of IP
Time Frame
Up to 4 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant, participant's parent, guardian, or LAR must provide signed 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 participant. Male or females 18 years of age and older at the time of the first dose of IP. SE warranting imminent progression of treatment meeting the following criteria: a) A diagnosis of SE, warranting imminent progression of treatment for seizure control, 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. Participants must have received a benzodiazepine and at least 1 of the following IV AEDs for treatment of the current episode of SE administered at an adequate dose and for a sufficient duration, in the judgement of the investigator, to demonstrate efficacy. The benzodiazepine and at least 1 of the IV AEDs must have been administered at a dose that would be expected to be effective for the termination of the current episode of SE. 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. Exclusion Criteria: Life expectancy of less than 24 hours. Anoxic brain injury or an uncorrected, rapidly reversable metabolic condition as the primary cause of SE (eg, hypoglycemia < 50 milligrams per deciliter [mg/dL] or hyperglycemia > 400 mg/dL). Participants who have received high-dose IV anesthetics (eg, 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 admission to the ICU or 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 milliliters per minute per 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. Known or suspected history or evidence of a medical condition that, in the investigator's judgment, would expose a participant to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marinus
Email
clinicaltrials@marinuspharma.com
Facility Information:
Facility Name
Kepler University Hospital
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raimund Helbok
Facility Name
Paracelsus Medical University Salzburg, Christian Doppler University Hospital, Department of Neurology
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eugen Trinka
Email
eugen@trinka.at
Facility Name
Medical University Vienna
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ekaterina Pataraia
Facility Name
Hôpital Universitaire de Bruxelles - Hôpital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas Gaspard
Phone
+32 2 5553429
Email
Nicolas.Gaspard@erasme.ulb.ac.be
Facility Name
UZA University Hospital Antwerpen
City
Edegem
ZIP/Postal Code
2650 Edegem
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Weckhuysen
Facility Name
University Hospitals UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wim Van Paesschen
Email
wim.vanpaesschen@uzleuven.be
Facility Name
University Hospital Centre Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zdravka Poljakovic
Email
zdravka.po@gmail.com
Facility Name
Dubrava University Hospital
City
Zagreb
ZIP/Postal Code
10040
Country
Croatia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Davor Sporis
Email
dsporis@kbd.hr
Facility Name
Mazaryk University, Brno,The First Department of Neurology
City
Brno
ZIP/Postal Code
60200
Country
Czechia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milan Brazdil
Email
milan.brazdil@fnusa.cz
Facility Name
University Hospital Ostrava
City
Ostrava
ZIP/Postal Code
70852
Country
Czechia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petr Hon
Email
petr.hon@fno.cz
Facility Name
Motol University Hospital
City
Prague
ZIP/Postal Code
150 06
Country
Czechia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Krysl
Email
david.krysl@fnmotol.cz
Facility Name
University Hospital Righospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ioannis Tsiropoulos
Email
ioannis.tsiropoulos@regionh.dk
Facility Name
Helsinki University Hospital
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Strbian
Email
Daniel.Strbian@hus.fi
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
702210
Country
Finland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reetta Kälviäinen
Email
reetta.kalviainen@uef.fi
Facility Name
Hopital R. Salengro
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phillippe Derambure
Email
philippe.derambure@chru-lille.fr
Facility Name
Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69002
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvian Rheims
Phone
+33-472-357106
Email
sylvain.rheims@chu-lyon.fr
Facility Name
CHRU Nancy
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louise Tyvaert
Facility Name
Chu de Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence Rulquin
Email
rulquin.f@chu-toulouse.fr
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hajo Hamer
Facility Name
Epilepsy Center Hessen
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susanne Knake
Email
knake@med.uni-marburg.de
Facility Name
University of Osnabruck, Dep of Neurology, Osnabrück
City
Osnabrück
ZIP/Postal Code
49076
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Kellinghaus
Email
christoph.kellinghaus@klinikum-os.de
Facility Name
Universität- und Rehabilitationskliniken Ulm, RKU
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Wagner
Facility Name
National Institute of Clinical Neurosciences
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Kelemen
Email
kelemenanna@hotmail.com
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
12000
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatma Shalabi
Phone
+972 549859344
Email
sfat@hadassah.org.il
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel aviv
ZIP/Postal Code
64239
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Firas Fahoum
Email
firasf@tlvmc.gov.il
Facility Name
Sheba Medical Center
City
Tel HaShomer
ZIP/Postal Code
526560
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Maggio
Email
nicola.maggio@sheba.health.gov.il
Facility Name
Università Cattolica del Sacro Cuore
City
Milan
ZIP/Postal Code
00-168
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Domenica Battaglia
Facility Name
Azienda Ospedaliera Universitaria di Modena
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Meletti
Email
stefano.meletti@unimore.it
Facility Name
Azienda Ospedaliera Universitaria Integrata di Verona
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiziano Zanoni
Facility Name
Vilnius University Hospital Santaros Klinikos
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruta Mameniskiene
Email
ruta.mameniskiene@santa.lt
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanna Siuda
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08004
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Estevo Santamarina
Email
estevo.santamarina@vallhebron.cat
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irene Morales
Email
garciamorales2@gmail.com
Facility Name
Centre Hospitalier Universitaire Vaudois (CHUV)
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Rossetti
Email
Andrea.Rossetti@chuv.ch
Facility Name
Oxford University Hospitals NHS Foundation Trust
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arjune Sen
Email
arjune.sen@ouh.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

To Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus (RSE)

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