A Phase 1b/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of ABS-1230 Administered to Pediatric and Young Adult Participants With KCNT1-Related Epilepsy
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 21
Healthy Volunteers: f
View:
• 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
Locations
United States
New Jersey
Northeast Regional Epilepsy Group
RECRUITING
Hackensack
Contact Information
Primary
Medical Director Actio Biosciences, Inc.
info@actiobiosciences.com
+1 (858) 682-4042
Time Frame
Start Date: 2026-05-18
Estimated Completion Date: 2028-01
Participants
Target number of participants: 55
Treatments
Experimental: ABS-1230 (Part 1)
Experimental: ABS-1230 (Part 2)
Experimental: Placebo (Part 2)
Experimental: ABS-1230 (Part 3)
Related Therapeutic Areas
Sponsors
Leads: Actio Biosciences, Inc.