Condition or Therapy:

Tuberous Sclerosis Complex (TSC)

Category:

Neurosciences, Neurology

What is the goal of this study?

  • The goal of this study is to learn more about how babies who have Tuberous Sclerosis Complex (TSC) develop infantile spasms or seizures.
  • The objective of this study is to compare the developmental impact of early versus delayed treatment with vigabatrin.
  • In addition, researchers want to see if treatment with bigabatrin in TSC infants can prevent or lower the risk of developing infantile spasms or regractory seizures.

Who can join the study?

This study might be a good fit if your child is:

  • Up to 6 months old
  • Has no history of seizures or infantile spasms
  • Has a diagnosis of Tuberous Sclerosis (TSC)

What will happen if my child takes part in this study?

If you decide to participate in this study, you will be asked to bring your child to Seattle Children's Main Campus for up to 13 study visits until they are 3 years old.

Over the course of the study during these visits, your child will:

  • Have a physical exam by a doctor; an EEG (electroencephalogram), a device that records the electrical activity in the brain; eye exams; and assessments to look at early learning and motor and language development.

If your child is randomized to a blinded treatment Arm A, they will receive the study drug (vigabatrin) or placebo until they are 24 months old and followed until they are 36 months old. If your child has a seizure during the blinded treatment phase of the study, they will go on open label vigabatrin, which is Arm B. If your child enrolls in the study because they have never had a seizure and have a normal EEG, they will not be treated but will be followed until they are 36 months old. 

Who can I contact for more information?

To take part in this study or for more information, please call (206) 987-5402 or email the research coordinator.


Study Location(s):

Seattle Children's Hospital main campus

Principal Investigator:

Dr. Stephanie Randle