NCT07600736PHASE2Recruiting
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of ABS-1230 in Pediatric Participants With KCNT1-related Epilepsy
Actio Biosciences, Inc.
Start Date
5/18/2026
Completion Date
1/1/2028
Summary
This trial will evaluate the safety, tolerability, pharmacokinetics, and clinical activity of ABS-1230 compared with placebo in participants with KCNT1-related epilepsy
Detailed Description
This is a Phase 1b/2 study that consists of 3 parts. In part 1, participants will receive ABS-1230 for 12 weeks, with a follow-up period of 2 weeks. In part 2, participants will receive ABS-1230 or placebo for 12 weeks, with a follow-up period of 2 weeks. All participants who complete part 1 or part 2 will have the option to continue receiving ABS-1230 in an open-label extension study (part 3).
Eligibility Criteria
Age Range: No minimum to 21 years
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.
Interventions
DRUG
ABS-1230
DRUG
Placebo
Conditions
KCNT1-Related Epilepsy
Locations
Northeast Regional Epilepsy Group
Hackensack, New Jersey 07601
United States