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45 Participants NeededMy employer runs this trial

ABS-1230 for Epilepsy

(KYRON Trial)

MD
Overseen ByMedical Diretor Actio Biosciences, Inc.
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Actio Biosciences, Inc.
Must be taking: Antiseizure medications
Must not be taking: Phenytoin, Carbamazepine, Stiripentol, Quinidine
Disqualifiers: Medical condition, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

This trial is for children and young adults (1 month to under 22 years old) diagnosed with KCNT1-related epilepsy who have at least 4 motor seizures per week. Participants must be on no more than 6 seizure medications, with stable doses during the study.

Inclusion Criteria

I take 6 or fewer seizure medications and can keep my doses stable.
I have epilepsy caused by a KCNT1 gene mutation, confirmed by my doctor.
I am between 1 month and 22 years old.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive ABS-1230 for 12 weeks

12 weeks

Follow-up Part 1

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Part 2

Participants receive ABS-1230 or placebo for 12 weeks

12 weeks

Follow-up Part 2

Participants are monitored for safety and effectiveness after treatment

2 weeks

Open-label Extension

Participants may opt into continuation of treatment long-term with ABS-1230

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

  • ABS-1230

Trial Overview

The study compares a new drug called ABS-1230 to a placebo in young people with KCNT1-related epilepsy. It looks at safety, how well the body handles the drug, and its effects on seizures.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Placebo (Part 2)Experimental Treatment1 Intervention
Group II: ABS-1230 (Part 3)Experimental Treatment1 Intervention
Group III: ABS-1230 (Part 2)Experimental Treatment1 Intervention
Group IV: ABS-1230 (Part 1)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Actio Biosciences, Inc.

Lead Sponsor

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