General Study Questions

What are the potential benefits of being in this study?

Taking part in this study may or may not help treat your child's LM. Your child’s condition could improve, stay the same, or get worse.

However, the data collected from your child during this study may help doctors learn more about the study medicine and LMs, which may help future patients.

Is the study medicine safe?

Every medicine has possible side effects. Some people have side effects and some people do not.

The study medicine is similar to a medicine that has been used in other countries to treat LMs and other conditions for over 20 years. The possible side effects are based on what we know about the similar medicine, as well as from other research studies that use this study medicine.

These possible side effects may include swelling, redness, or pain in the area where the study medicine was injected. Your child may also be less hungry, more tired, have a fever, or throw up.

These possible side effects usually start within a few days after receiving the study medicine and go away within one or two weeks. Most side effects go away on their own, but other serious reactions can occur.

The study doctor will explain the possible side effects that could occur in more detail. You can ask the study doctor any questions that you have. Detailed information can be found in the Informed Consent Form.

My child is not yet 6 months of age. Can we join the study?

Your child can be checked for eligibility when they turn 6 months of age.

My child is turning 18 years of age soon. Can we join the study?

If you and your child consent to participate in the study before their 18th birthday, they can continue to participate in the study if they meet all other eligibility criteria.

Once a child turns 18 years of age, they are not eligible to join the study, but they may turn 18 during their participation in the study.

How long would my child be in the study?

Your child will be in the study for about 54 weeks.

How many times would we have to visit the study hospital/clinic?

Your child will have to visit the study hospital/clinic approximately 8 times.

Who is paying for this study?

Protara Therapeutics, Inc. is the sponsor of this study. Protara is a biopharmaceutical company committed to advancing transformative therapies for people with cancer and rare diseases.

Protara provides the funds for the study doctor and staff to conduct the study.

Do I have to pay for anything during the study?

There is no cost to you for the study medicine, doctor visits, or tests that are part of this study. You or your health insurance will need to pay for your child’s medical care that is not part of the study.

Will my child be paid for participating in the study?

You will be compensated for your time with a set amount for each visit completed.

Do you provide help with travel?

Yes. The study doctor can give you more information about this.

What if my child or I want to leave the study?

Study participation is 100% your choice. Even after joining the study, you or your child can change your mind at any time for any reason. The study doctor may want to see your child one last time to make sure all final safety checks are done.

What if I have more questions about the study?

Talk to your child's pediatrician or LM specialist. They can help connect you to the closest study hospital/clinic. The STARBORN-1 Study Team will be happy to answer any questions you have.