Spots Global Cancer Trial Database for Open-label Study of Adjunctive GNX Treatment in Children and Adults With TSC-related Epilepsy
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Trial Identification
Brief Title: Open-label Study of Adjunctive GNX Treatment in Children and Adults With TSC-related Epilepsy
Official Title: A Phase 3, Open-label Study of Adjunctive Ganaxolone (GNX) Treatment in Children and Adults With Tuberous Sclerosis Complex (TSC)-Related Epilepsy (TrustTSC OLE)
Study ID: NCT05604170
Conditions
Interventions
Study Description
Brief Summary: This is a Phase 3, global, open-label extension (OLE) study of adjunctive GNX treatment in children and adults with TSC who previously participated in either Study 1042-TSC-3001 or Study 1042-TSC-2001
Detailed Description:
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arkansas Children's Research Institute, Little Rock, Arkansas, United States
UCLA Mattel Children's Hospital, TSC Center, Los Angeles, California, United States
Children's Hospital of Orange County, Orange, California, United States
Children's Hospital Colorado, Aurora, Colorado, United States
Mid-Atlantic Epilepsy and Sleep Center, Bethesda, Maryland, United States
Mayo Clinic - Rochester, Rochester, Minnesota, United States
University of Rochester Medical Center, Rochester, New York, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Atrium Health/Levine Children's Hospital, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Penn State Children's Hospital, Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Le Bonheur Children's Hospital, Memphis, Tennessee, United States
Child Neurology Consultants of Austin (CNCA), Austin, Texas, United States
McGovern Medical School at the University of Texas Health Science Center, Houston, Texas, United States
Austin Health, Heidelberg, , Australia
Alfred Health, Melbourne, , Australia
Royal Melbourne Hospital, Parkville, , Australia
The Royal Children's Hospital Melbourne, Parkville, , Australia
Hôtel Dieu de Montréal - CHUM, Montréal, , Canada
CHU Sainte-Justine, Montréal, , Canada
The Hospital for Sick Children, Toronto, , Canada
Toronto Western Hospital, Toronto, , Canada
BC Children's Hospital, Vancouver, , Canada
Peking University First Hospital, Beijing, , China
Beijing Children Hospital, Capital Medical University, Beijing, , China
Chinese PLA General Hospital, Beijing, , China
The Affiliated Hospital of Guizhou Medical University, Beijing, , China
First Hospital of Jilin University, Jilin, , China
Chengdu's Women and Children's Central Hospital, Qingyang, , China
University Hospital of Lyon, Bron, , France
Robert-Debré Hospital, Paris, , France
Hôpital de la Pitié-Salpêtrière, Paris, , France
University Hospital of Rennes, Rennes, , France
University of Strasbourg, Strasbourg, , France
Epilepsie-Zentrum Bethel - Krankenhaus Mara, Bielefeld, , Germany
University Hospital Bonn, Bonn, , Germany
ZNN - Epilepsiezentrum Frankfurt am Main, Frankfurt, , Germany
Universitäts Krankenhaus Freiburg, Freiburg, , Germany
Gemeinschaftskrankenhaus Herdecke, Herdecke, , Germany
Epilepsiezentrum Kleinwachau gGmbH, Radeberg, , Germany
Soroka University Medical Center, Be'er Sheva, , Israel
Schneider Children´s Medical Center, Petah Tikva, , Israel
Tel-Aviv Sourasky Medical Center, Tel Aviv, , Israel
Azienda Ospedaliero-Universitaria Meyer, Firenze, , Italy
Pediatric Neurology and Muscular Diseases Unit - University of Genoa, Genova, , Italy
Policlinico Umberto I, Rome, , Italy
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Sant Joan de Déu, Barcelona, , Spain
Hospital Infantil Universitario Niño Jesús, Madrid, , Spain
Hospital Ruber International, Madrid, , Spain
Hospital Regional Universitario de Málaga, Málaga, , Spain
Hospital Universitario y Politécnico La Fe, Valencia, , Spain
Bristol Royal Hospital for Children, Bristol, , United Kingdom
NHS acute tertiary referral centre, John Radcliffe Hospital, Oxford, , United Kingdom
Salford Royal Hospital, Salford, , United Kingdom
Sheffield Children's Hospital, Sheffield, , United Kingdom
Contact Details
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