Spots Global Cancer Trial Database for A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset Seizures
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset Seizures
Official Title: A Three-arm, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Two Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) Who Have Refractory Partial-onset Seizures
Study ID: NCT01713946
Study Description
Brief Summary: This study evaluated the efficacy and safety of two trough-ranges of everolimus given as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who had refractory partial-onset seizures. The study consisted of 4 phases for each patient Baseline phase:\[From Screening Week -8 (V1) to randomization visit at Week 0 (V2)\], Core phase \[from randomization at Week 0 (V2) to Week 18 (V11)\], Extension phase \[from Week 18 (V11) until 48 weeks after the last patient had completed the core phase\] and Post Extension phase \[from end of Extension phase to end of study\].
Detailed Description:
Eligibility
Minimum Age: 2 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham SC, Birmingham, Alabama, United States
TGen/APNNA, Phoenix, Arizona, United States
University of California at Los Angeles SC, Los Angeles, California, United States
Children's Hospital Oakland SC, Oakland, California, United States
Children's Hospital of Orange County SC, Orange, California, United States
Rady Children's Hospital SC, San Diego, California, United States
Children's Hospital Colorado, Aurora, Colorado, United States
Connecticut Childrens Medical Center SC, Hartford, Connecticut, United States
University of Chicago SC - 2, Chicago, Illinois, United States
Kennedy Krieger Institute SC, Baltimore, Maryland, United States
Children's Hospital Boston SC, Boston, Massachusetts, United States
Minnesota Epilepsy Group - PA SC, Saint Paul, Minnesota, United States
Washington University School of Medicine SC-2, Saint Louis, Missouri, United States
Morristown Memorial Hospital SC-2, Morristown, New Jersey, United States
New York University Medical Center SC-3, New York, New York, United States
Cincinnati Children's Hospital Medical Center SC, Cincinnati, Ohio, United States
Oregon Health and Science University SC - 3, Portland, Oregon, United States
Children's Hospital of Philadelphia SC, Philadelphia, Pennsylvania, United States
LeBonheur Childrens Medical Group SC, Memphis, Tennessee, United States
Texas Scottish Rite Hospital for Children Texas Scottish, Dallas, Texas, United States
Texas Children s Hospital SC, Houston, Texas, United States
The University of Texas Medical School-Houston SC, Houston, Texas, United States
Novartis Investigative Site, Caba, Buenos Aires, Argentina
Novartis Investigative Site, Cordoba, , Argentina
Novartis Investigative Site, Randwick, New South Wales, Australia
Novartis Investigative Site, Parkville, Victoria, Australia
Novartis Investigative Site, Perth, Western Australia, Australia
Novartis Investigative Site, Jette, Brussel, Belgium
Novartis Investigative Site, Bruxelles, , Belgium
Novartis Investigative Site, Bruxelles, , Belgium
Novartis Investigative Site, Gent, , Belgium
Novartis Investigative Site, Leuven, , Belgium
Novartis Investigative Site, Vancouver, British Columbia, Canada
Novartis Investigative Site, Montreal, Quebec, Canada
Novartis Investigative Site, Cali, Valle Del Cauca, Colombia
Novartis Investigative Site, Bogotá, , Colombia
Novartis Investigative Site, Medellín, , Colombia
Novartis Investigative Site, Aarhus, , Denmark
Novartis Investigative Site, Amiens Cedex 1, , France
Novartis Investigative Site, Angers cedex 09, , France
Novartis Investigative Site, Bron Cedex, , France
Novartis Investigative Site, Lille Cedex, , France
Novartis Investigative Site, Marseille, , France
Novartis Investigative Site, Strasbourg Cedex, , France
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Bielefeld, , Germany
Novartis Investigative Site, Kehl-Kork, , Germany
Novartis Investigative Site, Kiel, , Germany
Novartis Investigative Site, Ioannina, GR, Greece
Novartis Investigative Site, Athens, , Greece
Novartis Investigative Site, Budapest, , Hungary
Novartis Investigative Site, Kaposvar, , Hungary
Novartis Investigative Site, Nyiregyhaza, , Hungary
Novartis Investigative Site, Dublin, , Ireland
Novartis Investigative Site, Bari, BA, Italy
Novartis Investigative Site, Bologna, BO, Italy
Novartis Investigative Site, Catania, CT, Italy
Novartis Investigative Site, Genova, GE, Italy
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Pavia, PV, Italy
Novartis Investigative Site, Roma, RM, Italy
Novartis Investigative Site, Siena, SI, Italy
Novartis Investigative Site, Okayama-city, Okayama, Japan
Novartis Investigative Site, Izumi-city, Osaka, Japan
Novartis Investigative Site, Suita-city, Osaka, Japan
Novartis Investigative Site, Shizuoka-city, Shizuoka, Japan
Novartis Investigative Site, Setagaya-ku, Tokyo, Japan
Novartis Investigative Site, Osaka, , Japan
Novartis Investigative Site, Seoul, Korea, Korea, Republic of
Novartis Investigative Site, Seoul, Korea, Korea, Republic of
Novartis Investigative Site, Seoul, Korea, Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Guadalajara, Jalisco, Mexico
Novartis Investigative Site, Heeze, , Netherlands
Novartis Investigative Site, Rotterdam, , Netherlands
Novartis Investigative Site, Utrecht, , Netherlands
Novartis Investigative Site, Oslo, , Norway
Novartis Investigative Site, Warszawa, , Poland
Novartis Investigative Site, Samara, Samara Region, Russian Federation
Novartis Investigative Site, Voronezh, Voronezh Region, Russian Federation
Novartis Investigative Site, Moscow, , Russian Federation
Novartis Investigative Site, Moscow, , Russian Federation
Novartis Investigative Site, Sevilla, Andalucía, Spain
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain
Novartis Investigative Site, San Sebastian, Pais Vasco, Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Tainan, Taiwan ROC, Taiwan
Novartis Investigative Site, Kaohsiung City, , Taiwan
Novartis Investigative Site, Taipei, , Taiwan
Novartis Investigative Site, Bangkok, , Thailand
Novartis Investigative Site, Bangkok, , Thailand
Novartis Investigative Site, Bangkok, , Thailand
Novartis Investigative Site, Ankara, , Turkey
Novartis Investigative Site, Ankara, , Turkey
Novartis Investigative Site, Istanbul, , Turkey
Novartis Investigative Site, Birmingham, , United Kingdom
Novartis Investigative Site, Buckinghamshire, , United Kingdom
Novartis Investigative Site, Cambridge, , United Kingdom
Novartis Investigative Site, Liverpool, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Novartis Investigative Site, Sheffield, , United Kingdom
Novartis Investigative Site, York, , United Kingdom
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
