A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of ABS-1230 in Pediatric and Young Adult Participants With KCNT1-related Epilepsy
This trial will evaluate the safety, tolerability, pharmacokinetics, and clinical activity of ABS-1230 compared with placebo in participants with KCNT1-related epilepsy
Eligibility
Sex
ALL
Min age
1 Month
Max age
21 Years
Healthy volunteers
No
Inclusion Criteria:
* Aged 1 month to \<22 years
* Clinician-confirmed diagnosis of KCNT1-related epilepsy
* Has an average of at least 4 countable motor seizures per week
* Is taking no more than 6 antiseizure medications (ASM) and is able to keep stable doses of ASMs for the duration of Part 1 or Part 2
Exclusion Criteria:
* Is currently taking phenytoin, carbamazepine, stiripentol, or quinidine
* Has a medical condition that, in the opinion of the investigator, would limit the participant's ability to participate in the study or might compromise participant safety or interfere with evaluation of the study drug.
Primary outcome measure(s)
Part 1: Safety and tolerability of ABS-1230 (incidence and severity of adverse events) — Measured from Day 1 to End of Study or Early Termination (up to 12 weeks) Safety and tolerability of ABS-1230 by determining the incidence and severity of treatment emergent adverse events
Part 2: Efficacy of ABS-1230 — Measured from Day 1 to End of Study or Early Termination (up to 12 weeks) Percentage change from baseline in countable motor seizures (normalized per 28 days) as recorded in the seizure diary
Part 3: Safety and tolerability of ABS-1230 (incidence and severity of adverse events) — Measured from Day 1 of Part 3 to End of Study or Early Termination (up to 1 year) Safety and tolerability of ABS-1230 by determining the incidence and severity of treatment emergent adverse events
Trial sites (1)
Facility
City
Region
Status
Northeast Regional Epilepsy Group
Hackensack
New Jersey
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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