Frequently
Asked
Questions

How do we participate?

If you are interested, speak with your child’s doctor. They can help determine if your child may be eligible and provide information about next steps. You may also explore whether your child or family member is eligible by completing this form.

Why is there a randomized arm in the trial where some participants may receive a placebo?

To truly understand if ABS-1230 is safe and effective, researchers need to compare ABS-1230 to a placebo (a substance with no active medicine). This helps researchers understand if changes in the trial participant’s seizure activity, possible side effects, safety events and lab results are due to the medicine itself and not something else. To ensure study integrity, Part 2 participants and their doctor will not know if they received ABS-1230 or placebo.

All Part 2 participants, including those who received placebo, will have the opportunity to join an open-label long-term extension trial where everyone will receive ABS-1230.

Will this trial affect current medications?

Most participants may continue their existing seizure medications if doses have been consistent for approximately two months and will not be changed for the duration of the trial. However, some medications cannot be taken with ABS-1230 and may need to be safely stopped before trial participation begins, allowing time for the medications to fully clear from your system. Please consult your doctor prior to participation in the trial. Should you want to participate in the study, your doctor will monitor any medication changes closely.

Do we need to travel to a hospital?

This trial is decentralized, meaning trial visits happen at home through telemedicine, home nursing visits, and in-home EEG testing. You will have the option to go to a site in-person if that is preferred.

Who will cover the cost of participating in clinical trials, such as laboratory tests or travel?

The study sponsor, Actio Biosciences, will cover the cost of trial-related tests and procedures. Families will not be asked to pay for participation. Travel is minimal, with the majority of the trial being conducted remotely/from home.

If I, my family member, or my child is not eligible for the clinical trial, is Actio Biosciences able to provide compassionate use or expanded access?

Please see our full expanded access policy.

When will ABS-1230 be available outside of the United States?

ABS-1230 is still in the early stages of clinical development in the U.S. Please see our expanded access policy for potential access outside of the U.S. Clinical trials conducted outside of the U.S. will depend on future trial results, ongoing development, and approval by the U.S. FDA and other regulatory agencies.

Can my child travel to the U.S. to participate in this clinical trial?

We understand that many families outside the United States may be interested in participating in this study. While we are grateful for that interest, there are some important considerations to keep in mind.

Actio Biosciences cannot provide advice about visas, immigration, travel, or relocation, and we cannot guarantee that any child will be enrolled in the trial. Enrollment depends on several factors, including whether a child meets the study’s eligibility requirements and whether space is available at a participating study site.

Children who participate in the trial must remain in the United States for the entire study, including all scheduled visits, assessments, and long-term follow-up care.

Can I pay to participate in the trial?

Participation is voluntary and cannot involve payment in exchange for access to investigational treatments.