Northeast Regional Epilepsy Group
Hackensack, New Jersey, 07601, United States
Location status: Recruiting
Recruiting
NCT Number: NCT07600736
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of ABS-1230 in Pediatric 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
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
1 month–21 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
About this study
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).
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
ABS-1230
DrugOnce daily
Placebo
DrugOnce daily
Primary outcomes
-
Part 1: Safety and tolerability of ABS-1230 (incidence and severity of adverse events)
Time frame: 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
Time frame: 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)
Time frame: 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
Secondary outcomes
-
Maximum Plasma Concentration [Cmax] of ABS-1230
Time frame: Measured from Day 1 to End of Study or Early Termination (up to 12 weeks)
Pharmacokinetics of ABS-1230
-
Total Exposure [AUCtau] ABS-1230
Time frame: Measured from Day 1 to End of Study or Early Termination (up to 12 weeks)
Pharmacokinetics of ABS-1230
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Actio Biosciences, Inc.
Industry
Registry information
Official study title
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
Acronym: KYRON
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- May 22, 2026
- Registry last updated
- Jun 17, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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