A Clinical Research Study for Children Teens and Young Adults Diagnosed With Dravet Syndrome The Skyline Study

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Dravet Syndrome
  • Age: Between 2 Year(s) - 21 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Individuals 2 to 21 years old.
    2. Has been diagnosed with Dravet syndrome.
    3. Has had 12 or more convulsive seizures over 12 weeks prior to screening.
    4. Has been unable to control seizures with at least 1 anti-seizure medication in the past.

You may not be eligible for this study if the following are true:

    1. Takeda employees or immediate family members.
    2. Currently enrolled in a clinical study involving an investigational product or nonapproved use of a drug or device (other than the investigational product used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
    3. Participated in a clinical study involving another study drug in the last 30 days (or 5 half-lives of the study drug, whichever is longer) before screening (Visit 1).
    4. Unwilling to withhold the fruit and juice of grapefruit, Seville oranges, and starfruit from their diet during the entire clinical trial.
    5. Use of herbal preparations (when used as an ASM) or artisanal cannabidiol (CBD) during the entire clinical trial.
    6. Currently pregnant or breastfeeding or is planning to become pregnant within 30 days of the last dose of study drug.

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.