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
Actio Biosciences, Inc.
Summary
This trial will evaluate the safety, tolerability, pharmacokinetics, and clinical activity of ABS-1230 compared with placebo in participants with KCNT1-related epilepsy
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
- Age range
- 0–21 years
- Sex
- All
- 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 evalu…
Interventions
- DrugABS-1230
Once daily
- DrugPlacebo
Once daily
Location
- Northeast Regional Epilepsy GroupHackensack, New Jersey