Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus

Marinus Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Status Epilepticus; Epilepsy; Non Convulsive Status Epilepticus; Convulsive Status EPILEPTICUS

Treatments: Drug: IV Ganaxolone active; Drug: IV Placebo, non-active

Study type: Interventional

Funder types: Industry

Identifiers

NCT03350035

1042-SE-2001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects 12 years of age and older
• Clinical and/or electrographic seizures

Exclusion criteria

• Life expectancy of less than 24 hours
• Anoxic brain injury as primary cause of SE
• Recent (<24 hour) traumatic brain injury as the primary cause of SE
• Administered anesthesia for the treatment of SE

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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17 participants in 2 patient groups, including a placebo group

IV Ganaxolone active

Experimental group

Description:

Ganaxolone IV loading dose with continuous infusion (maintenance dose) for 2-4 days followed by an 18-hour taper.

Treatment:

Drug: IV Ganaxolone active

IV Placebo, non-active

Placebo Comparator group

Description:

Placebo IV loading dose with continuous infusion (maintenance dose) for 2-4 days followed by an 18-hour taper.

Treatment:

Drug: IV Placebo, non-active