A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of ABS-1230 in Pediatric and Young Adult Participants With KCNT1-related Epilepsy
Recruiting · NCT07600736 · Interventional (participants receive a specific treatment) · Lead sponsor: Actio Biosciences, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
ABS-1230Placebo
What this trial is about
This trial will evaluate the safety, tolerability, pharmacokinetics, and clinical activity of ABS-1230 compared with placebo in participants with KCNT1-related epilepsy
Who can take part
Age range
1 Month to 21 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- Northeast Regional Epilepsy Group - Hackensack, New Jersey, United States