drugset
drugset / Trial / NCT04391569

Randomized Therapy In Status Epilepticus

NCT04391569 ↗

Phase 3 Completed 100 enrolled Marinus Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start
2020-12-09
Primary completion
2024-03-30
Completion
2024-04-28

Outcome

Mixed primary results

registry NUMBER Ganaxolone: 79.59 (65.657 to 89.755) Percentage of participants NCT04391569 ↗

registry NUMBER Placebo: 12.77 (4.832 to 25.741) Percentage of participants NCT04391569 ↗

registry analysis (other test); Ganaxolone vs Placebo; p = 0.0000; fixed weight combination test NCT04391569 ↗

registry NUMBER Ganaxolone: 63.27 (48.288 to 76.578) Percentage of participants NCT04391569 ↗

registry NUMBER Placebo: 51.06 (36.064 to 65.924) Percentage of participants NCT04391569 ↗

registry analysis (other test); Ganaxolone vs Placebo; p = 0.1619; fixed weight combination test NCT04391569 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ganaxolone Small molecule — Intravenous

Indications

No indication recorded.