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Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus

NCT03350035 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2023-03-09

Study results available
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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.

Conditions

  • Status Epilepticus
  • Convulsive Status EPILEPTICUS
  • Non Convulsive Status Epilepticus
  • Epilepsy

Interventions

DRUG

IV Ganaxolone active

IV

DRUG

IV Placebo, non-active

IV

Sponsors & Collaborators

  • Marinus Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Maciej Gasior, MD, PhD · Marinus Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-19
Primary Completion
2019-09-18
Completion
2019-09-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03350035 on ClinicalTrials.gov