Tuberous Sclerosis Complex research hub
4 indexed studies · 0 currently recruiting
- active not recruitingPHASE1, PHASE2
Astroscape: A Study of Radiprodil on Safety, Tolerability, Pharmacokinetics, and Effect on Seizures and Behavioral Symptoms in Patients With TSC or FCD Type II
This study, called Astroscape, is testing a new medicine called radiprodil for children and young people aged 6 months to 18 years. It's for those with Tuberous Sclerosis Complex (TSC) or Focal Cortical Dysplasia (FCD Type II) who experience difficult-to-treat seizures.
Australia · Belgium · Canada - ongoing, recruitingTherapeutic confirmatory (Phase III)
An Open-label, Single-arm Study to Assess the Safety, Pharmacokinetics, and Efficacy of Adjunctive Cannabidiol Oral Solution (GWP42003‑P) in Participants with Tuberous Sclerosis Complex (1 Month to < 2 Years of Age), Dravet Syndrome (1 Year to < 2 Years of Age), or Lennox-Gastaut Syndrome (1 Year to < 2 Years of Age) who Experience Inadequately‑controlled Seizures
This study looks at a medicine called Epidyolex for young children with Dravet Syndrome, Tuberous Sclerosis Complex, or Lennox-Gastaut Syndrome. It checks if the medicine is safe, how much stays in the body, and if it helps reduce seizures. This is a big final-stage study.
Italy · Spain - ongoing, recruitingTherapeutic exploratory (Phase II)
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 Seizures Associated with Tuberous Sclerosis Complex
This study is looking at a new medicine called Basimglurant for children, teenagers, and young adults with seizures caused by Tuberous Sclerosis Complex. It wants to see if the drug helps reduce seizures and if it's safe when added to their usual seizure medication.
Spain · Italy · Poland - active not recruitingPHASE3
Roll-over Study to Collect and Assess Long-term Safety of Everolimus in Patients With TSC and Refractory Seizures Who Have Completed the EXIST-3 Study [CRAD001M2304] and Who Are Benefitting From Continued Treatment
This study is for people with Tuberous Sclerosis Complex (TSC) and difficult-to-treat seizures who are already taking everolimus in a related study (EXIST-3) and benefitting from it. It aims to gather long-term information on the safety of everolimus.
United States · Australia · Belgium