The investigational product is currently approved to prevent migraine in adults. The safety and effectiveness of this investigational product in children is unknown.
Your child may qualify for the HORIZON Study if they:
Keep in mind that participation is entirely voluntary. If you and your child decide to take part in a study, you may change your mind about participating at any time.
What happens if I fill out the pre-screening questionnaire? If you pass the initial study screener, we will match you to a site location in your area running a clinical trial that needs pediatric volunteers diagnosed with chronic migraine or notify you when one becomes available. If there is not a current study for chronic migraine in your area, a Patient Engagement Specialist may reach out to you in the future via the email address or phone number (call or text) you provided to share information about new clinical trials for which your child may qualify.
Keep in mind that participation is entirely voluntary. If you and your child decide to take part in a study, you may change your mind about participating at any time.
Migraine is a severe, chronic neurological disease characterized by episodic attacks of
moderate-to-severe headache, sensory disturbances, and other symptoms. Migraine
represents a major cause of disability in adults and in children.
Although the peak prevalence of the condition typically occurs during adulthood,
migraine disease represents one of the most common childhood ailments.1
The prevalence of migraine in children is estimated at 7% to 10%, and about one-third of
people with migraine experience their first attack before adulthood.2 Among
children, a headache is the most common symptom and the most common source of pain when
experiencing a migraine attack.3
An accurate and timely diagnosis of migraine disease is vital to ensure prompt treatment
of the disease. To diagnose migraine headaches in children, the same criteria are used
to diagnose adults, but with differences in duration.4
The HORIZON Study is evaluating an investigational product for the prevention of
migraine headaches in children and teens between the ages of 12 to 17. The
investigational product is currently approved to treat migraine in adults. The safety
and effectiveness of this investigational product in children is unknown.
A clinical trial or study is a medical study that helps to answer important questions about an investigational product – these may include whether an investigational study product works for a certain condition. All medications must be tested in clinical research studies before they can be approved and prescribed to patients.
A clinical trial or study is the basis on which investigational products are evaluated to determine if they can be approved and brought to market.
The HORIZON Study is evaluating an investigational product for the prevention
of migraine headaches in children and teens between the ages of 12 to 17.
The investigational product is currently approved to prevent migraine in
adults. The safety and effectiveness of this investigational product in
children is unknown.
The HORIZON Study will last as short as several weeks or for up
to 5 months. Over 420 children and teens will be enrolled in the study,
which is being conducted at study sites across the world, including the
United States and Puerto Rico.
Eligible participants will receive the investigational product or the
placebo (a pill designed not to have any biological effects on your body).
The study team will provide more information when they contact you.
After completing the HORIZON study, your child may be eligible to
participate in another voluntary study and receive the investigational
product at no cost, for up to one year. Your child must qualify to
participate in the voluntary open-label extension study. Please discuss this
with the study team at the site when they contact you.
Volunteers who qualify to take part in the study may receive compensation for time and travel. Please discuss this with the study team at the site when they contact you.
There is no cost to participate in the HORIZON Study. If your child decides to take part:
The research team will be able to explain more about what the HORIZON Study will involve, and it is up to you and your child to decide if your child wants to take part. Participation in this study is voluntary. Whether or not you and your child decide to participate in this study will not affect your current or future relationships with your doctors. If you and your child decide to participate, your child is free to withdraw at any time without affecting those relationships.
We match you and your child to a study site within a close travel distance from your home. If we are not running the study in your area currently, with your permission, we will keep you in our database and reach out once a study in your area becomes available. If, at any time, you decided you no longer want your information stored, you can opt out and we will delete your details.
The HORIZON Study will enroll over 420 children and teens between the ages of 12 to 17
who suffer from chronic migraine at over 70 study sites across the world, including the
United States and Puerto Rico.
The study will include about 7 visits to a study site in your location over 20 weeks of
participation. Your child’s participation may be as short as several weeks or for up to
5 months.
Your child may qualify for the HORIZON Study if they:
All study-related visits, tests, and investigational product will be provided at no cost
to you or your insurance. In addition, compensation for time and travel may be provided.
The HORIZON Study is evaluating an investigational product for the prevention of
migraine headaches in children and teens between the ages of 12 to 17. The
investigational product is currently approved to prevent migraine in adults. The safety
and effectiveness of this investigational product in children is unknown.