Recruiting
Phase 2

ABS-1230

Sponsor:

Actio Biosciences, Inc.

Code:

NCT07600736

Conditions

KCNT1-Related Epilepsy

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

ABS-1230

Placebo

Study Details

Brief summary:

This trial will evaluate the safety, tolerability, pharmacokinetics, and clinical activity of ABS-1230 compared with placebo in participants with KCNT1-related epilepsy

Conditions

KCNT1-Related Epilepsy

Study ID

NCT07600736

Start date

May 18, 2026

Status verified date

Oct, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

61 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ABS-1230 (Part 1)

experimental: ABS-1230 (Part 2)

experimental: Placebo (Part 2)

experimental: ABS-1230 (Part 3)

Interventions

ABS-1230

Daily

Placebo

Daily

Primary outcome measure

  • Part 1: Safety and tolerability of ABS-1230 (incidence and severity of adverse events) [ Time Frame: Measured from Day 1 to End of Study or Early Termination (up to 12 weeks) ]
  • Part 2: Efficacy of ABS-1230 [ Time Frame: Measured from Day 1 to End of Study or Early Termination (up to 12 weeks) ]
  • Part 3: Safety and tolerability of ABS-1230 (incidence and severity of adverse events) [ Time Frame: Measured from Day 1 of Part 3 to End of Study or Early Termination (up to 1 year) ]

Central Contacts and Locations

Central contacts

Medical Director Actio Biosciences, Inc.

+1 (858) 682-4042info@actiobiosciences.com

Locations

Northeast Regional Epilepsy Group

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Hardik Rana

551-497-5000HRana@epilepsygroup.com

Principal Investigator:

Eric Segal, MD

More Information

Sponsor

Actio Biosciences, Inc.

Last update posted

Oct 15, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Actio Biosciences, Inc. on 2026-10-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.