About the ASTROSCAPE Study

The ASTROSCAPE Study will help us learn if a potential new treatment (also called an investigational drug) named radiprodil, can help children and adolescents who have Tuberous Sclerosis Complex (TSC) or Focal Cortical Dysplasia (FCD) Type II and seizures which are not controlled by medications. Investigational radiprodil is not yet approved for use in children or adolescents with TSC or FCD Type II.

About 30 children and adolescents will join the ASTROSCAPE Study from approximately 6 different countries around the world.

The ASTROSCAPE Study brings together a team of doctors and staff who are specialists in their field and dedicated to exploring medical knowledge about TSC and FCD Type II. Regular clinic visits will be scheduled, as they want to make sure study participants are doing well throughout the study.

Study Participation

To be considered for the ASTROSCAPE Study your child:

  • Must have been diagnosed with Tuberous Sclerosis Complex (TSC) or Focal Cortical Dysplasia (FCD) Type II
  • Must be aged between 6 months and 18 years old
  • Must have seizures which at least 2 anti-seizure medicines have failed to control

Other eligibility criteria apply and will be discussed at the screening visit. Study participants will receive study-related medical exams and active investigational radiprodil at no cost. If travel is required, a service will help arrange it for you and all reasonable related costs will be covered, to the extent allowable in your country. Children who enroll in this study will be asked to participate for approximately 18 weeks in Part A of the study, with the potential to continue for another 1 year if they enter Part B. During this time, they will be asked to visit the clinic about 13 times in Part A of the study and about 6 times in Part B.

See if your child pre-qualifies

What Are Clinical Trials?

Clinical trials are research studies that people and their families can participate in to help find answers to specific research questions.

Clinical trials are conducted according to a plan called a protocol that describes:

  • the type of patients that can participate in the study
  • the test schedules and procedures
  • the drug concerned
  • what is known about the medicine from its previous use in animals or humans
  • the dosages or amount of the drug
  • the duration of the study
  • what researchers hope to learn from the study

Volunteers participating in a study must agree to the rules and conditions outlined in the protocol. Similarly, researchers, physicians, and other health professionals managing clinical trials must follow strict rules set by regulatory bodies such as the European Medicines Agency (EMA), Health Canada and Therapeutic Goods Administration (TGA). These rules ensure that those who agree to participate are treated as safely as possible.

For many people, participation in a clinical trial is important because their participation contributes to a better understanding of diseases and how to treat them. Some other benefits of participating are:

  • Active participation in your child's health and healthcare
  • Access to healthcare providers who specialize in the condition under investigation
  • Knowing that you may be helping others with the condition, as well as your child