Clinical Trials Directory

Trials / Completed

CompletedNCT03350035

Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus

A Double-Blind Randomized, Placebo Controlled Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
17 (actual)
Sponsor
Marinus Pharmaceuticals · Industry
Sex
All
Age
12 Years
Healthy volunteers
Not accepted

Summary

This study will evaluate the effectiveness and safety of an investigational drug, IV ganaxolone, as adjunctive therapy to standard of care to treat subjects with status epilepticus.

Detailed description

This is a double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, and efficacy of adjunctive IV ganaxolone in subjects with SE. Study drug 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 study drug as adjunctive therapy by continuous IV. Subject's will be followed up for 3 weeks post-treatment. Subjects who are known to be at risk for SE may be consented and/or assented prior to an SE event.

Conditions

Interventions

TypeNameDescription
DRUGIV Ganaxolone activeIV
DRUGIV Placebo, non-activeIV

Timeline

Start date
2018-02-19
Primary completion
2019-09-18
Completion
2019-09-18
First posted
2017-11-22
Last updated
2023-03-09
Results posted
2022-12-15

Locations

8 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03350035. Inclusion in this directory is not an endorsement.