Spots Global Cancer Trial Database for Adjunctive GNX Treatment Compared With Placebo in Children and Adults With TSC-related Epilepsy
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Trial Identification
Brief Title: Adjunctive GNX Treatment Compared With Placebo in Children and Adults With TSC-related Epilepsy
Official Title: A Phase 3, Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone (GNX) Treatment in Children and Adults With Tuberous Sclerosis Complex (TSC)-Related Epilepsy (TrustTSC)
Study ID: NCT05323734
Conditions
Study Description
Brief Summary: This is a Phase 3, global, double-blind, randomized, placebo-controlled study of adjunctive GNX treatment in children and adults with TSC-related epilepsy. The study consists of a 4-week prospective Baseline phase, defined as the first 28 days following screening, followed by a double-blind phase consisting of a 4-week titration period (Day 1 to Day 28) and a 12-week maintenance period (Day 29 to Week 16).
Detailed Description:
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Barrow Neurological Institute at Phoenix Children's Hospital, Phoenix, Arizona, United States
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
Childrens Hospital Colorado, Aurora, Colorado, United States
Nemours Children's Hospital - Delaware Valley, Wilmington, Delaware, United States
University of Florida Gainesville, Gainesville, Florida, United States
NW FL Clinical Research Group, LLC, Gulf Breeze, Florida, United States
Nicklaus Children's Hospital, Miami, Florida, United States
Orlando Health, Orlando, Florida, United States
Comprehensive Neurology Clinic, Orlando, Florida, United States
Children's Healthcare of Atlanta, Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States
Mid-Atlantic Epilepsy and Sleep Center, Bethesda, Maryland, United States
Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, United States
Children's Hospital of Michigan Central Michigan University, Detroit, Michigan, United States
Mayo Clinic - Rochester, Rochester, Minnesota, United States
Children's Mercy Hosptial, Kansas City, Missouri, United States
TSC Clinic at Northeast Regional Epilepsy Group, Hackensack, New Jersey, United States
Institute of Neurology and Neurosurgery at Saint Barnabas, Livingston, New Jersey, 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
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, 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
University of Texas Southwestern Medical Center, Dallas, Texas, United States
McGovern Medical School at the University of Texas Health Science Center, Houston, Texas, United States
University of Utah Health Care-Pediatric Neurology, Salt Lake City, Utah, United States
Seattle Children's Hospital, Seattle, Washington, United States
Hôtel Dieu de Montréal - CHUM, Montreal, , Canada
CHU Sainte-Justine, Montréal, , Canada
The Hospital for Sick Children, Toronto, , Canada
Toronto Western Hospital, Toronto, , Canada
BC Children's Hospital, Vancouver, , Canada
University Hospital of Lyon, Bron, , France
University Hospital of Lille, Lille, , France
Robert-Debré Hospital, 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, Beer-Sheva, , Israel
Hadassah Medical Center, Jerusalem, , Israel
Schneider Children´s Medical Center, Petah Tikva, , Israel
Sheba Medical Center, Tel Hashomer, , 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
Children's Hospital Bambino Gesù, Rome, , 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
Royal Aberdeen Children's Hospital, NHS Grampian, Aberdeen, , United Kingdom
Bristol Royal Hospital for Children, Bristol, , United Kingdom
Leeds General Infirmary, Leeds, , 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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