Advanced Discovery Research is looking for children age 4-5 to participate in a study for attention deficit/hyperactivity disorder (ADHD). If your child qualifies, you may be compensated up to $825.00 for your participation.
While ADHD is usually diagnosed in school-aged kids, symptoms may first show up in preschool-aged children. ADHD symptoms like hyperactivity and inattention can impact every aspect of a child’s life, from their relationship with families and friends to their performance in school and group activities. That’s why we’re asking you and your child to consider taking part in the 812P401 Study. We’re evaluating a study medication called SPN-812 to see if it may help preschool-age children (4 to 5 years old) who are living with ADHD.
SPN-812 is approved by the U.S. Food and Drug Administration (FDA) as Qelbree and is used for the treatment of ADHD in pediatric patients ages 6 to 17.
The aim of the 812P401 Study is to learn about SPN-812 as a possible treatment for ADHD in preschool-aged children. The study will test how well SPN-812 works and how safe it is compared with a placebo, which looks like the SPN-812 capsule but has no active ingredients. About 286 preschool-age children will take part in the 812P401 Study.
Your child may qualify if:
- He or she is between 4 years and 5 years 9 months of age
- Has been diagnosed with ADHD
- Has tried a course of non-medication treatment OR has symptoms severe enough to warrant treatment with medication
- Is attending a structured group activity (such as preschool, kindergarten, sports, Sunday school, or childcare)
Why Take Part?
While your child may not directly benefit from the study, taking part will help us learn more about the study medication and treating ADHD in preschool-aged children. Children in the study will receive at no cost:
- The study medication or placebo
- Close study-related medical care and follow-up throughout the study
How long will the study last and what is involved?
The 812P401 Study will last about 10 weeks and includes at least 8 visits to the study center. During the first visit, your study doctor will see if your child qualifies to take part. If so, your child will be randomly placed in 1 of 2 groups:
- SPN-812, taken daily by mouth (50% chance)
- Placebo, taken daily by mouth (50% chance)
Taking part in the 812P401 Study includes:
- Screening: Up to 4 weeks
- Treatment: 6 weeks
- Follow-up: A phone call 1 week after the end of the study
After completing the study, you will have the chance to enroll your child in an extension study. In the extension, all children will take the study medication. There is no placebo.
What risks are involved for study participants?
There are possible risks involved with any clinical study. The research doctor will review the risks with you, and your child will be closely monitored by the research staff throughout the study.
About Clinical Studies
A clinical research study (sometimes also called a trial) is carefully overseen research that is done before a study medication becomes available to the public.
- Studies follow certain rules to protect the safety, rights, well-being, and privacy of participants.
- Studies are an important way to bring about new medical treatments to improve patient care.
It is up to you whether you would like your child to take part in the study, and you can change your mind about taking part at any time.
Deciding not to take part in the study or leaving the study after joining will not affect your child’s usual medical care, either now or in the future.
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