KCNT1-Related EpilepsyPhase 2KYRONNCT07600736
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of ABS-1230 in Pediatric and Young Adult Participants With KCNT1-related Epilepsy
A Phase 2 study testing ABS-1230 in people with KCNT1-Related Epilepsy, run by Actio Biosciences, Inc. at 2 sites in United States.
Trial summary
This trial will evaluate the safety, tolerability, pharmacokinetics, and clinical activity of ABS-1230 compared with placebo in participants with KCNT1-related epilepsy Read more about this study
- Who is it for?
- Ages 1 month to 21 years
- Conditions the study is for
- KCNT1-Related Epilepsy
- What is being tested?
- ABS-1230
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 May 2026to Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Northeast Regional Epilepsy Group
Hackensack, New Jersey, 07601
Hardik Rana, 551-497-5000, HRana@epilepsygroup.com
Eric Segal, MD
- Not yet recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Naomi Taggart, 858-274-0204, Naomi_Taggart@URMC.Rochester.edu
David Bearden, MD
About this study
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
This trial will evaluate the safety, tolerability, pharmacokinetics, and clinical activity of ABS-1230 compared with placebo in participants with KCNT1-related epilepsy
Read the detailed description
This is a Phase 1b/2 study that consists of 3 parts.
In part 1, participants will receive ABS-1230 for 12 weeks, with a follow-up period of 2 weeks.
In part 2, participants will receive ABS-1230 or placebo for 12 weeks, with a follow-up period of 2 weeks.
All participants who complete part 1 or part 2 will have the option to continue receiving ABS-1230 in an open-label extension study (part 3).
- Conditions
- KCNT1-Related Epilepsy
- Being tested
- ABS-1230, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABS-1230Drug
Daily
PlaceboDrug
Daily
| Study group | Role | What they receive |
|---|---|---|
| ABS-1230 (Part 1) | Experimental | Not described Receives: Drug: ABS-1230 |
| ABS-1230 (Part 2) | Experimental | Not described Receives: Drug: ABS-1230 |
| Placebo (Part 2) | Experimental | Not described Receives: Drug: Placebo |
| ABS-1230 (Part 3) | Experimental | Not described Receives: Drug: ABS-1230 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Safety and tolerability of ABS-1230 (incidence and severity of adverse events)
Safety and tolerability of ABS-1230 by determining the incidence and severity of treatment emergent adverse events
Measured: Measured from Day 1 to End of Study or Early Termination (up to 12 weeks)
Part 2: Efficacy of ABS-1230
Percentage change from baseline in countable motor seizures (normalized per 28 days) as recorded in the seizure diary
Measured: 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)
Safety and tolerability of ABS-1230 by determining the incidence and severity of treatment emergent adverse events
Measured: Measured from Day 1 of Part 3 to End of Study or Early Termination (up to 1 year)
Secondary outcomes (2)
Maximum Plasma Concentration [Cmax] of ABS-1230
Pharmacokinetics of ABS-1230
Measured: Measured from Day 1 to End of Study or Early Termination (up to 12 weeks)
Total Exposure [AUCtau] ABS-1230
Pharmacokinetics of ABS-1230
Measured: Measured from Day 1 to End of Study or Early Termination (up to 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start18 May 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KCNT1-Related EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Actio Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600736
- Sponsor's protocol ID
- ABS1230-1101
- Acronym
- KYRON
- Status last verified
- Oct 2026
- First submitted
- 14 May 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07600736
- Acronym / sponsor ID
- KYRON / ABS1230-1101
- Conditions
- KCNT1-Related Epilepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Actio Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 May 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will evaluate the safety, tolerability, pharmacokinetics, and clinical activity of ABS-1230 compared with placebo in participants with KCNT1-related epilepsy
Detailed description
This is a Phase 1b/2 study that consists of 3 parts.
In part 1, participants will receive ABS-1230 for 12 weeks, with a follow-up period of 2 weeks.
In part 2, participants will receive ABS-1230 or placebo for 12 weeks, with a follow-up period of 2 weeks.
All participants who complete part 1 or part 2 will have the option to continue receiving ABS-1230 in an open-label extension study (part 3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ABS-1230 (Part 1) | Experimental | Drug: ABS-1230 |
| ABS-1230 (Part 2) | Experimental | Drug: ABS-1230 |
| Placebo (Part 2) | Experimental | Drug: Placebo |
| ABS-1230 (Part 3) | Experimental | Drug: ABS-1230 |
Who may qualify
- Ages
- 1 month to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABS-1230Daily | Drug | ABS-1230 (Part 1), ABS-1230 (Part 2), ABS-1230 (Part 3) |
| PlaceboDaily | Drug | Placebo (Part 2) |
Primary outcome
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)
Safety and tolerability of ABS-1230 by determining the incidence and severity of treatment emergent adverse events
Part 2: Efficacy of ABS-1230
Time frame: Measured 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)
Time frame: 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
2 secondary outcomes
Maximum Plasma Concentration [Cmax] of ABS-1230
Time frame: Measured from Day 1 to End of Study or Early Termination (up to 12 weeks)
Total Exposure [AUCtau] ABS-1230
Time frame: Measured from Day 1 to End of Study or Early Termination (up to 12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABS-1230 in people with KCNT1-Related Epilepsy, run by Actio Biosciences, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Director Actio Biosciences, Inc. (+1 (858) 682-4042, info@actiobiosciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.