RAISE: RAndomized Therapy In Status Epilepticus

Sponsor

Marinus Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04391569

Collaborator

(none)

124

Enrollment

Locations

Arms

16.7

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the effectiveness and safety of an investigational product, IV ganaxolone, to treat subjects with status epilepticus.

Condition or Disease	Intervention/Treatment	Phase
Status Epilepticus Convulsive Status EPILEPTICUS Non-Convulsive Status Epilepticus Epilepsy	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 before IV anesthetic during the treatment of SE. Subjects will be screened for inclusion/exclusion criteria prior to receiving investigational product by continuous IV infusion. Subjects will be followed for approximately 4 weeks.

Subjects who are known to be at risk for SE may be consented or assented prior to an SE event.

Study Design

Study Type:

Interventional

Anticipated 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 :

Oct 10, 2020

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: IV Placebo Placebo bolus dose followed by continuous infusion for 36 hours, followed by 12 hour taper	Drug: Placebo Double-blind study that will randomize subjects to ganaxolone or placebo in 1:1 ratio.
Experimental: IV ganaxolone active Ganaxolone bolus dose followed by continuous infusion for 36 hours, followed by 12 hour taper	Drug: Ganaxolone Double-blind study that will randomize subjects to ganaxolone or placebo in 1:1 ratio.

Arm

Intervention/Treatment

Placebo Comparator: IV Placebo

Placebo bolus dose followed by continuous infusion for 36 hours, followed by 12 hour taper

Drug: Placebo

Double-blind study that will randomize subjects to ganaxolone or placebo in 1:1 ratio.

Experimental: IV ganaxolone active

Ganaxolone bolus dose followed by continuous infusion for 36 hours, followed by 12 hour taper

Drug: Ganaxolone

Double-blind study that will randomize subjects to ganaxolone or placebo in 1:1 ratio.

Outcome Measures

Primary Outcome Measures

SE Cessation [30 minutes]
Proportion of participants with status epilepticus cessation within 30 minutes of IP initiation without medications for the acute treatment of status epilepticus. SE cessation is determined by clinical and EEG findings.
Progression to IV anesthesia [36 hours]
Proportion of participants with no progression to IV anesthesia for 36 hours following IP initiation

Secondary Outcome Measures

Progression to IV anesthesia [72 hours]
No progression to IV anesthesia for 72 hours following IP initiation
SE Cessation [48 hours]
Time to SE cessation following IP initiation

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

clinical and/or electrographic seizures

Exclusion Criteria:

life expectancy of less than 24 hours
anoxic brain injury or an uncontrolled metabolic condition as primary cause of SE
treatment of current SE episode with IV anesthetics

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marinus Research Site	Birmingham	Alabama	United States	35017
2	Marinus Research Site	Mobile	Alabama	United States	36617
3	Marinus Research Site	Phoenix	Arizona	United States	85006
4	Marinus Research Site	Phoenix	Arizona	United States	85013
5	Marinus Research Site	Phoenix	Arizona	United States	85016
6	Marinus Research Site	Downey	California	United States	90242
7	Marinus Research Site	Los Angeles	California	United States	90048
8	Marinus Research Site	Orange	California	United States	92868
9	Marinus Research Site	Sacramento	California	United States	95816
10	Marinus Research Site	Sacramento	California	United States	95817
11	Marinus Research Site	San Diego	California	United States	92037
12	Marinus Research Site	Aurora	Colorado	United States	80045
13	Marinus Research Site	New Haven	Connecticut	United States	06520
14	Marinus Research Site	Gainesville	Florida	United States	32611
15	Marinus Research Site	Gulf Breeze	Florida	United States	32561
16	Marinus Research Site	Jacksonville	Florida	United States	32224
17	Marinus Research Site	Miami	Florida	United States	33155
18	Marinus Research Site	Orlando	Florida	United States	32803
19	Marinus Research Site	Chicago	Illinois	United States	60611
20	Marinus Research Site	Chicago	Illinois	United States	60612
21	Marinus Research Site	Urbana	Illinois	United States	61801
22	Marinus Research Site	Iowa City	Iowa	United States	52242
23	Marinus Research Site	Louisville	Kentucky	United States	40202
24	Marinus Research Site	New Orleans	Louisiana	United States	70121
25	Marinus Research Site	Shreveport	Louisiana	United States	71103
26	Marinus Research Site	Baltimore	Maryland	United States	21215
27	Marinus Research Site	Boston	Massachusetts	United States	02111
28	Marinus Research Site	Boston	Massachusetts	United States	02118
29	Marinus Research Site	Ann Arbor	Michigan	United States	48109
30	Marinus Research Site	Detroit	Michigan	United States	48201
31	Marinus Research Site	Grand Rapids	Michigan	United States	49503
32	Marinus Research Site	Rochester	Minnesota	United States	55905
33	Marinus Research Site	Jackson	Mississippi	United States	39206
34	Marinus Research Site	Kansas City	Missouri	United States	64108
35	Marinus Research Site	Saint Louis	Missouri	United States	63110
36	Marinus Research Site	Omaha	Nebraska	United States	68105
37	Marinus Research Site	New Brunswick	New Jersey	United States	08901
38	Marinus Research Site	Albany	New York	United States	12208
39	Marinus Research Site	Brooklyn	New York	United States	11203
40	Marinus Research Site	Buffalo	New York	United States	14203
41	Marinus Research Site	New York	New York	United States	10032
42	Marinus Research Site	New York	New York	United States	10075
43	Marinus Research Site	Rochester	New York	United States	14642
44	Marinus Research Site	Charlotte	North Carolina	United States	28207
45	Marinus Research Site	Durham	North Carolina	United States	27710
46	Marinus Research Site	Winston-Salem	North Carolina	United States	27103
47	Marinus Research Site	Winston-Salem	North Carolina	United States	27157
48	Marinus Research Site	Cincinnati	Ohio	United States	45267
49	Marinus Research Site	Columbus	Ohio	United States	43210
50	Marinus Research Site	Portland	Oregon	United States	97225
51	Marinus Research Site	Portland	Oregon	United States	97239
52	Marinus Research Site	Philadelphia	Pennsylvania	United States	19104
53	Marinus Research Site	Philadelphia	Pennsylvania	United States	19140
54	Marinus Research Site	Pittsburgh	Pennsylvania	United States	15212
55	Marinus Research Site	West Reading	Pennsylvania	United States	19611
56	Marinus Research Site	Charleston	South Carolina	United States	29425
57	Marinus Research Site	Knoxville	Tennessee	United States	37920
58	Marinus Research Site	Memphis	Tennessee	United States	38103
59	Marinus Research Site	Dallas	Texas	United States	75390
60	Marinus Research Site	Fort Worth	Texas	United States	76104
61	Marinus Research Site	Galveston	Texas	United States	77555
62	Marinus Research Site	San Antonio	Texas	United States	78229

Sponsors and Collaborators

Marinus Pharmaceuticals

Investigators

Study Director: Maciej Gasior, MD, PhD, Marinus Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marinus Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT04391569

Other Study ID Numbers:

1042-SE-3003

First Posted:

May 18, 2020

Last Update Posted:

Jun 8, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Marinus Pharmaceuticals

seizure

Additional relevant MeSH terms:

Status Epilepticus

Ganaxolone

Study Results

No Results Posted as of Jun 8, 2021