Clin2
NCT05249556Possibly a fitNot yet recruiting

Ganaxolone trial for babies and toddlers with CDKL5 seizures

CDKL5 Deficiency Disorder

Part of Brain & nervous system, Genetic & congenital clinical trials.

This trial tests ganaxolone, a seizure medicine, to see if it can reduce seizures in young children with CDKL5 deficiency. Participants get the real medicine or a placebo, and families help track seizures every day.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 3
Enrollment
20 people
Ages
6 months to 2 years
Study type
Interventional

Who can take part

  • Child has a confirmed CDKL5 diagnosis with a likely disease-causing gene change
  • Child is 6 months to under 2 years old
  • Seizures have not been controlled despite trying one or more anti-seizure medicines at the right doses
  • In the 28 days before screening, the child had at least 8 countable seizures (with clear movement)
  • Seizure medicines are stable for at least 2 weeks, and doses won’t be changed during the main blinded part
  • Caregiver can keep accurate daily seizure log entries and give study medicine with food three times daily

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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