KCNT1-Related EpilepsyRare diseaseGeneticsChildren's healthDrugPhase 2
What this study is
This trial will evaluate the safety, tolerability, pharmacokinetics, and clinical activity of ABS-1230 compared with placebo in participants with KCNT1-related epilepsy
What's being tested
- ABS-1230
Intervention · DRUG
- Placebo
Intervention · DRUG
Both interventions
Daily
Study details
- Official title
- 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
- Sponsor
- Actio Biosciences, Inc.
- Conditions
- KCNT1-Related Epilepsy
- Enrolling
- 61 people
- Starts
- 2026-05-18
- Est. completion
- 2028-01
- Design
- Triple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 1 Month – 21 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (2)
2 openNortheast Regional Epilepsy Group
Hackensack, New Jersey, United States
- Hardik Rana · Contact551-497-5000HRana@epilepsygroup.com
- Eric Segal, MD · Principal investigator
RecruitingUniversity of Rochester Medical Center
Rochester, New York, United States
- Naomi Taggart · Contact858-274-0204Naomi_Taggart@URMC.Rochester.edu
- David Bearden, MD · Principal investigator
Not yet recruiting
Study team
Sponsor
Actio Biosciences, Inc.
Study ID ABS1230-1101
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.