A Study of ABS-1230 for KCNT1-Related Epilepsy in Children and Young Adults
This study is testing a new drug called ABS-1230 for children and young adults with KCNT1-related epilepsy. Researchers want to see if ABS-1230 is safe, how well the body handles it (pharmacokinetics), and if it helps reduce seizures. Some participants will receive ABS-1230, while others will receive a placebo (an inactive substance). The study will measure side effects and how well the drug works over 12 weeks, with some participants continuing for up to a year. You might be able to join if you are between 1 month and 21 years old, have a confirmed diagnosis of KCNT1-related epilepsy, and experience at least 4 seizures per week. The study aims to enroll 45 participants.
- Study design
- This is a Phase 1b/2 interventional study with three parts, involving up to 45 participants. In some parts, participants will be randomly assigned to receive either ABS-1230 or a placebo.
- What's involved
- Participants will receive ABS-1230 or placebo daily for 12 weeks in Part 1 or Part 2. Those who complete these parts may continue receiving ABS-1230 in an open-label extension for up to a year.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants are followed for 2 weeks after the 12-week treatment period in Part 1 and Part 2. In Part 3, participants are followed for up to 1 year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of ABS-1230 in Pediatric and Young Adult Participants With KCNT1-related Epilepsy
At a glance
Conditions
NCT07600736
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Northeast Regional Epilepsy Group
Hackensack, New Jerseystudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Part 1: Safety and tolerability of ABS-1230 (incidence and severity of adverse events)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-1230Measured 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)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