Open-Label PoC Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies

Completed · Phase 2

Conditions studied: Epilepsy

In brief

To evaluate the efficacy of open-label ganaxolone as adjunctive therapy for uncontrolled seizures in female children with PCDH19 mutation and other rare genetic epilepsies in an open-label proof-of-concept study.

Key facts

Study ID

NCT02358538

Run by

Marinus Pharmaceuticals

People needed

30

Starts

2015-11-06

Expected to finish

2019-01-04

Last updated by the study team

2023-03-21

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Sutter Institute for Medical Research — Sacramento, California, United States
• University of California San Francisco — San Francisco, California, United States
• Center for Rare Neurological Diseases — Norcross, Georgia, United States
• JWM Neurology — Indianapolis, Indiana, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Northeast Regional Epilepsy Group — Hackensack, New Jersey, United States
• Institute of Neurology and Neurosurgery at St. Barnabas — Livingston, New Jersey, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Bambino Gesu Children's Hospital, IRCCS — Rome, Italy

Full record on ClinicalTrials.gov

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