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Completed Phase 3 Interventional Results available

Randomized Therapy In Status Epilepticus

ClinicalTrials.gov ID: NCT04391569

Public ClinicalTrials.gov record NCT04391569. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 8:25 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous Ganaxolone in Status Epilepticus

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study evaluated the effectiveness and safety of an investigational product (IP), intravenous (IV) ganaxolone, to treat participants with status epilepticus (SE).

Study identification

NCT ID
NCT04391569
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Marinus Pharmaceuticals
Industry
Enrollment
100 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
12 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 9, 2020 (Actual)
Primary completion
Mar 30, 2024 (Actual)
Completion
Apr 28, 2024 (Actual)
Last update posted
May 29, 2025

2020 – 2024

United States locations

U.S. sites
64
U.S. states
26
U.S. cities
49
Facility City State ZIP Site status
Marinus Research Site Birmingham Alabama 35233 —
Marinus Research Site Phoenix Arizona 85013 —
Marinus Research Site Little Rock Arkansas 72205 —
Marinus Research Site Downey California 90242 —
Marinus Research Site La Jolla California 92037 —
Marinus Research Site Orange California 92868 —
Marinus Research Site Sacramento California 95817 —
Marinus Research Site Aurora Colorado 80045 —
Marinus Research Site Denver Colorado 80204 —
Marinus Research Site New Haven Connecticut 06510 —
Marinus Research Site Gainesville Florida 32608 —
Marinus Research Site #1 Miami Florida 33136 —
Marinus Research Site Miami Florida 33136 —
Marinus Research Site Miami Florida 33155 —
Marinus Research Site Port Saint Lucie Florida 34987 —
Marinus Research Site Tampa Florida 33606 —
Marinus Research Site Chicago Illinois 60611 —
Marinus Research Site Chicago Illinois 60612 —
Marinus Research Site Urbana Illinois 61801 —
Marinus Research Site Louisville Kentucky 40202 —
Marinus Research Site New Orleans Louisiana 70121 —
Marinus Research Site Shreveport Louisiana 71103 —
Marinus Research Site #1 Baltimore Maryland 21201 —
Marinus Research Site Baltimore Maryland 21201 —
Marinus Research Site Baltimore Maryland 21215 —
Marinus Research Site Boston Massachusetts 02111 —
Marinus Research Site Boston Massachusetts 02114 —
Marinus Research Site Boston Massachusetts 02115 —
Marinus Research Site Boston Massachusetts 02118 —
Marinus Research Site Boston Massachusetts 02215 —
Marinus Research Site Worcester Massachusetts 01655 —
Marinus Research Site Ann Arbor Michigan 48109 —
Marinus Research Site Grand Rapids Michigan 49503 —
Marinus Research Site Columbia Missouri 65212 —
Marinus Research Site St Louis Missouri 63110 —
Marinus Research Site New Brunswick New Jersey 08901 —
Marinus Research Site Albuquerque New Mexico 87106 —
Marinus Research Site Albany New York 12208 —
Marinus Research Site Brooklyn New York 11203 —
Marinus Research Site New York New York 10029 —
Marinus Research Site New York New York 10032 —
Marinus Research Site Rochester New York 14642 —
Marinus Research Site Chapel Hill North Carolina 27514 —
Marinus Research Site Charlotte North Carolina 28203 —
Marinus Research Site Durham North Carolina 27710 —
Marinus Research Site Cincinnati Ohio 45219 —
Marinus Research Site Cleveland Ohio 44195 —
Marinus Research Site Columbus Ohio 43210 —
Marinus Research Site Portland Oregon 97225 —
Marinus Research Site Portland Oregon 97239 —
Marinus Research Site #1 Philadelphia Pennsylvania 19104 —
Marinus Research Site #2 Philadelphia Pennsylvania 19104 —
Marinus Research Site Philadelphia Pennsylvania 19104 —
Marinus Research Site Philadelphia Pennsylvania 19107 —
Marinus Research Site Philadelphia Pennsylvania 19140 —
Marinus Research Site Pittsburgh Pennsylvania 15212 —
Marinus Research Site Knoxville Tennessee 37920 —
Marinus Research Site Memphis Tennessee 38103 —
Marinus Research Site Dallas Texas 75235 —
Marinus Research Site Fort Worth Texas 76104 —
Marinus Research Site San Antonio Texas 78229 —
Marinus Research Site Murray Utah 84107 —
Marinus Research Site Richmond Virginia 23298 —
Marinus Research Site Madison Wisconsin 53792 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04391569, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 29, 2025 · Synced Oct 24, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04391569 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →