Extended trial tests seizure Drug's safety for rare genetic disorder

NCT ID NCT05604170

Terminated Disease control Sponsor: Marinus Pharmaceuticals Source: ClinicalTrials.gov ↗

Summary

This study aimed to evaluate the long-term safety and effectiveness of an add-on medication called ganaxolone for controlling seizures in children and adults with Tuberous Sclerosis Complex (TSC). It was an extension study for 117 participants who had completed earlier ganaxolone trials, allowing them to continue treatment while researchers monitored for side effects and changes in seizure frequency. The main goal was to gather more information about the drug's safety profile and its ability to reduce seizures over a longer period.

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Contacts and locations

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Locations

Alfred Health

Melbourne, VIC 3004, Australia
Arkansas Children's Research Institute

Little Rock, Arkansas, 72202, United States
Atrium Health/Levine Children's Hospital

Charlotte, North Carolina, 28207, United States
Austin Health

Heidelberg, VIC 3084, Australia
BC Children's Hospital

Vancouver, V6H 3V4, Canada
Beijing Children Hospital, Capital Medical University

Beijing, 100045, China
Boston Children's Hospital, Harvard Medical School

Boston, Massachusetts, 02115, United States
Bristol Royal Hospital for Children

Bristol, BS2 8AE, United Kingdom
CHU Sainte-Justine

Montreal, H3T 1C5, Canada
Child Neurology Consultants of Austin (CNCA)

Austin, Texas, 78757, United States
Children's Hospital Colorado

Aurora, Colorado, 80045, United States
Children's Hospital of Orange County

Orange, California, 92868, United States
Children's Mercy Hospital

Kansas City, Missouri, 64108, United States
Chinese PLA General Hospital

Beijing, 100853, China
Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States
Duke University Medical Center

Durham, North Carolina, 27712, United States
Epilepsie-Zentrum Bethel - Krankenhaus Mara

Bielefeld, 33617, Germany
Epilepsiezentrum Kleinwachau gGmbH

Radeberg, 1454, Germany
First Hospital of Jilin University

Jilin, 130021, China
Gemeinschaftskrankenhaus Herdecke

Herdecke, 58313, Germany
Hospital Infantil Universitario Niño Jesús

Madrid, 28009, Spain
Hospital Regional Universitario de Málaga

Málaga, 29010, Spain
Hospital Ruber International

Madrid, 28034, Spain
Hospital Sant Joan de Déu

Barcelona, 8950, Spain
Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain
Hospital de la Santa Creu i Sant Pau

Barcelona, 8025, Spain
Hôpital Sud

Rennes, 35000, France
Hôtel Dieu de Montréal - CHUM

Montreal, H2X 0C2, Canada
Le Bonheur Children's Hospital

Memphis, Tennessee, 38103, United States
Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States
McGovern Medical School at the University of Texas Health Science Center

Houston, Texas, 77030, United States
Nemours Children's Hospital - Delaware Valley

Wilmington, Delaware, 19803, United States
Pediatric Neurology and Muscular Diseases Unit - University of Genoa

Genova, 16147, Italy
Peking University First Hospital

Beijing, 100034, China
Policlinico Umberto I

Rome, 00185, Italy
Rady Children's Hospital - San Diego

San Diego, California, 92123, United States
Royal Brisbane and Women's Hospital

Herston, QLD 4029, Australia
Royal Melbourne Hospital

Parkville, VIC 3050, Australia
Schneider Children´s Medical Center

Petah Tikva, 4920235, Israel
Seattle Children's Hospital

Seattle, Washington, 98105, United States
Sheffield Children's Hospital

Sheffield, S10 2TH, United Kingdom
The Affiliated Hospital of Guizhou Medical University

Beijing, 550004, China
The Hospital for Sick Children

Toronto, M5G 1X8, Canada
Toronto Western Hospital

Toronto, M5T 2S8, Canada
UCLA Mattel Children's Hospital, TSC Center

Los Angeles, California, 90095, United States
University Hospital Bonn

Bonn, 53127, Germany
University Hospital of Lyon

Bron, 69229, France
University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States
University of Rochester Medical Center

Rochester, New York, 14642, United States
University of Strasbourg

Strasbourg, 67084, France
University of Texas Southwestern Medical Center

Dallas, Texas, 75207, United States
University of Utah Health Care-Pediatric Neurology

Salt Lake City, Utah, 84108, United States
Universitäts Krankenhaus Freiburg

Freiburg im Breisgau, 79106, Germany
ZNN - Epilepsiezentrum Frankfurt am Main

Frankfurt, 60528, Germany

Conditions

Explore the condition pages connected to this study.

TUBEROUS SCLEROSIS COMPLEX