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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT02358538

Public ClinicalTrials.gov record NCT02358538. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 7:35 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter, Open-Label Proof-of-Concept Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies Followed by 52 Week Open-Label Treatment

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02358538
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Marinus Pharmaceuticals
Industry
Enrollment
30 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
2 Years to 18 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 6, 2015 (Actual)
Primary completion
Jan 16, 2018 (Actual)
Completion
Jan 4, 2019 (Actual)
Last update posted
Mar 21, 2023

2015 – 2019

United States locations

U.S. sites
9
U.S. states
7
U.S. cities
9
Facility City State ZIP Site status
Phoenix Children's Hospital Phoenix Arizona 85016 —
Sutter Institute for Medical Research Sacramento California 95816 —
University of California San Francisco San Francisco California 94143 —
Center for Rare Neurological Diseases Norcross Georgia 30093 —
JWM Neurology Indianapolis Indiana 46239 —
Boston Children's Hospital Boston Massachusetts 02115 —
Northeast Regional Epilepsy Group Hackensack New Jersey 07601 —
Institute of Neurology and Neurosurgery at St. Barnabas Livingston New Jersey 07039 —
Nationwide Children's Hospital Columbus Ohio 43205 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02358538, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 21, 2023 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02358538 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →