Spots Global Cancer Trial Database for Basimglurant in Children, Adolescents, and Young Adults With TSC
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Trial Identification
Brief Title: Basimglurant in Children, Adolescents, and Young Adults With TSC
Official Title: A Phase 2B, Multicenter, 30-week, Prospective, Cross-over, Double-blind, Randomized, Placebo-controlled Study Followed by a 52-Week Open-label Extension Study to Evaluate the Efficacy and Safety of Basimglurant Adjunctive to Ongoing Anticonvulsive Therapy in Children, Adolescents, and Young Adults With Uncontrolled Seizures Associated With Tuberous Sclerosis Complex
Study ID: NCT05059327
Conditions
Study Description
Brief Summary: The study intends to show that basimglurant provides effective seizure control in children, adolescents and young adults with Tuberous Sclerosis Complex (TSC).
Detailed Description: The study drug (basimglurant) is a potent inhibitor of metabotropic glutamate receptor 5 (mGluR5) which controls a wide range of processes in the brain, spinal cord, retina, and peripheral nervous system. In animal studies, the inhibition of this receptor has shown therapeutic potential for the treatment of Tuberous Sclerosis Complex (TSC). This receptor's inhibition decreases the frequency of seizures. In previous clinical trials, the study drug has shown an advantageous safety profile in children and adolescents. The objective of this study is to find an optimal dose at which the study drug will lead to a decrease in the duration, frequency and intensity of seizures in children, adolescents and young adults with TSC, while being well tolerated. All patients who positively respond and tolerate the medicine will be offered the possibility to continue in an open label extension.
Keywords
Eligibility
Minimum Age: 5 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
David Geffen School of Medicine at UCLA (Site #: 101), Los Angeles, California, United States
Kennedy Krieger Institute (Site #: 110), Baltimore, Maryland, United States
Boston Children's Hospital (Site #: 102), Boston, Massachusetts, United States
William Beaumont Hospital - Royal Oak (Site #: 104), Royal Oak, Michigan, United States
Minnesota Epilepsy Group PA (Site #: 105), Roseville, Minnesota, United States
Boston Children's Health Physicians (BCHP) (Site #: 111), Hawthorne, New York, United States
Duke Children's Hospital and Health Center (Site #: 106), Durham, North Carolina, United States
University Hospitals Cleveland Medical Center, Rainbow Babies and Childrens Hospital (Site #: 107), Cleveland, Ohio, United States
Texas Scottish Rite Hospital For Children (Site #: 113), Dallas, Texas, United States
The University of Texas Medical School at Houston (Site #: 103), Houston, Texas, United States
Multicare Health System (Site #: 109), Tacoma, Washington, United States
Citi Neuro Centre (Site # 806), Hyderabad, Andhra Pradesh, India
Rainbow Children's Hospital (Site # 803), Hyderabad, Andhra Pradesh, India
All India Institute of Medical Sciences (Site # 804), New Delhi, Delhi, India
Jaslok Hospital and Research Centre (Site # 801), Mumbai, Maharashtra, India
Deenanath Mangeshkar Hospital and Research Centre (Site # 805), Pune, Maharashtra, India
Gleneagles Global Health City (Site # 802), Chennai, Tamil Nadu, India
Christian Medical College (Site # 807), Vellore, Tamil Nadu, India
Hadassah Medical Center - PPDS (Site #: 503), Jerusalem, , Israel
ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo (Site # 181), Milano, Lombardia, Italy
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda (Site # 183), Milano, Lombardia, Italy
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele (Site # 182), Catania, Sicilia, Italy
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN (Site # 184), Firenze, Toscana, Italy
Instytut Pomnik Centrum Zdrowia Dziecka (Site # 262), Warsaw, Mazowieckie, Poland
Centrum Medyczne Plejady (Site # 263), Kraków, , Poland
AmiCare Centrum Medyczne (Site # 261), Łódź, , Poland
Hospital Universitario Germans Trias i Pujol (Site # 194), Badalona, Barcelona, Spain
Hospital Sant Joan de Deu - PIN (Site # 192), Esplugues De Llobregat, Barcelona, Spain
Hospital Regional Universitario de Malaga - Hospital General (Site # 193), Málaga, , Spain
Centro de Neurología Avanzada (Site # 191), Sevilla, , Spain
Ankara Etlik Şehir Hastanesi (Site #: 903), Yenimahalle, Ankara, Turkey
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi (Site #: 905), Fatih, Istanbul, Turkey
Yeditepe University Kosuyolu Hospital (Site #: 904), Kadıköy, Istanbul, Turkey
Istanbul Egitim ve Arastirma Hastanesi (Site #: 901), Sultangazi, Istanbul, Turkey
Salford Royal Hospital - PPDS (Site # 304), Salford, Lancashire, United Kingdom
The Royal London Hospital (Site # 302), London, London, City Of, United Kingdom
St George Hospital (Site # 303), London, London, City Of, United Kingdom
Cardiff University (Site # 305), Cardiff, South Glamorgan, United Kingdom
Noahs Ark Children's Hospital (Site # 306), Cardiff, South Glamorgan, United Kingdom
Queen Elizabeth Hospital Birmingham (Site # 301), Birmingham, West Midlands, United Kingdom
Contact Details
Name: Clinical Director, MD
Affiliation: Noema Pharma AG
Role: STUDY_DIRECTOR
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