RecruitingPhase 2NCT07600736
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of ABS-1230 in Pediatric Participants With KCNT1-related Epilepsy
A Phase 1b/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of ABS-1230 Administered to Pediatric Participants With KCNT1-Related Epilepsy
Sponsor
Actio Biosciences, Inc.
Enrollment
45 participants
Start Date
May 1, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
This trial will evaluate the safety, tolerability, pharmacokinetics, and clinical activity of ABS-1230 compared with placebo in participants with KCNT1-related epilepsy
Eligibility
Min Age: 1 MonthMax Age: 21 Years
Inclusion Criteria4
- 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 Criteria2
- 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.
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Interventions
DRUGABS-1230
Once daily
DRUGPlacebo
Once daily
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07600736