This research study is for an investigational nasal spray for migraine pain in children ages 6 to 11 years old.

As a parent, it is hard to see your child in pain and not be able to find a solution that can provide relief.

Currently, there are few medications approved to treat migraine headache in young children ages 6 -11 years old. As a result, medical researchers are exploring future treatment possibilities. One option for you to consider is the ROCKET study evaluating an investigational Zolmitriptan nasal spray for migraine headaches in children ages 6 -11 years old.

Zolmitriptan nasal spray (ZNS) has been approved by the United States Food and Drug Administration (FDA) for prescription use in the treatment of migraine headaches in adults and adolescents ages 12-17. However, it has not been approved by the FDA for the treatment of migraine headaches in children under 12 years old, which means it is investigational for the purposes of this study in this age range.

In this study, study doctors want to compare ZNS to placebo, which looks like ZNS, but contains no active medication. They want to measure how effective and safe ZNS is when it is used by children ages 6 -11 years old to treat migraine headaches.

The results of this study will provide more information about ZNS and whether it could one day be used by children ages 6 -11 years old for migraine headache pain relief.

About Medical Research Studies

Pharmaceutical companies use medical research studies like the ROCKET study to learn more about investigational drugs before they are approved and made available to the public. The results of this study will provide more information about whether ZNS is safe and effective when used to treat migraine headaches in children ages 6 - 11. By taking part in this study, your child may be making an important contribution to pediatric migraine research.

Who is eligible to participate in the ROCKET study?

To pre-qualify for this study, your child must:

  • Be 6 to 11 years of age
  • Have a medical diagnosis of migraine, with or without aura
  • Have at least 2 migraine attacks per month
  • Not experience pain relief with over-the-counter pain medications

All study-related visits, tests, and drugs will be provided at no cost. In addition, reimbursement for study-related travel may be available.

What will happen during the ROCKET study?

This study has two main parts. Part 1 will last up to 20 weeks, and Part 2 will last up to 6 months.

If you and your child agree to participate in this study and your child is eligible, he or she will start the study in Part 1. Your child will have up to 6 weeks to use the study drug one time on a single migraine.

If your child continues to be eligible, your child will be randomly assigned (like flipping a coin) to either ZNS or placebo. You, your child, the study doctor, and the study staff will not know what study drug (ZNS or placebo) your child is receiving. This is to prevent any opinions about either study drug from affecting the study results. However, in the event of an emergency, this information can be provided.

Your child will go through two more dosing periods where he or she can use the study drug to treat a single migraine attack within 6 weeks. After Part 1 ends, your child may have the opportunity to participate in Part 2 where all patients will receive ZNS to treat up to 4 migraine attacks per month.

Your child’s total study participation will last approximately 11 months, which includes 7 scheduled visits to the study clinic. During Part 2 of the study, you may also need to return to the clinic to obtain more study drug for your child.

What are the benefits and risks related to the ROCKET study?

While ZNS has shown to be safe and effective for adults and adolescents ages 12-17 with migraine headaches, your child may not receive any benefit for participating in this study. However, information from this study may help children with migraine headaches in the future.

It is possible your child could experience a side effect in this study. Before your child begins this study, the study staff will explain the potential risks and side effects related to the study.

Because research studies can affect the health and safety of participants, your child will be monitored during this study. Researchers for the study designed a protocol, which explains all study procedures in complete detail. An independent review board responsible for ensuring participant safety has reviewed and approved this protocol. The board also requires that the protocol be followed exactly as written.

What if I have questions?

The ROCKET study staff is always available to answer any questions you or your child may have about this study and the study drugs. Contact us at 715-387-5185 or 715-389-3748 for more information.