Does your child or teen have ADHD, or struggle with symptoms of ADHD?
See if one of the FOCUS studies is right for your child and your family.
Who Can Participate?
The FOCUS studies are looking for children and teens who*:
- Are 6-17 years old
- Have a primary diagnosis of ADHD, or experience the symptoms of ADHD, which will be confirmed at the first visit
- Can swallow medicine capsules with water
How Can My Child Participate?
Step 1
Complete the online questionnaire here to see if your child may be eligible.
Step 2
If your child meets certain conditions and you want to learn more, your information will be sent to a study site near you.
Step 3
Study site staff will contact you to talk more about the study and get more information on your child's health history. You and your child may be invited to the study site for a first visit.
Step 4
At the study site, the study doctor and their team will talk to you about participation in the study. After you have asked all of your questions, you will be asked to sign a consent form to allow your child to participate. Your child may also have to sign an assent form.
Click the button below to fill out a quick form to see if your child may be eligible for the FOCUS-2 or FOCUS-3 study.
If you are under the age of 18, you may not directly fill out this form, and your parent or legal guardian must complete it on your behalf. By filling out this form, you are confirming you meet these requirements. By entering in your information, you are under no obligation to participate in the study. Your information will be forwarded to the study site closest to you where a member of the staff will reach out via phone, email, or text to collect more information.
About the Studies
The goal of the FOCUS-2 and FOCUS-3 studies is to see if the investigational medicine (solriamfetol) is safe and effective for use in children ages 6-11 (FOCUS-2) and adolescents ages 12-17 (FOCUS-3) with ADHD. Solriamfetol is approved by the FDA for adults who have excessive daytime sleepiness due to obstructive sleep apnea (OSA) and narcolepsy, which are sleep-related disorders. Solriamfetol is an investigational treatment for ADHD, meaning it has not yet been approved by any health authority for the treatment of ADHD.
The studies are double-blind and placebo controlled, meaning that some children may take solriamfetol and other children may take placebo. A placebo looks exactly like solriamfetol but does not have any active medicine in it. Using placebo is often required in clinical studies to scientifically compare and prove that the study medicine works. Neither you nor the study staff will know if your child is receiving the study medicine or placebo, but in case of a medical emergency, the study doctor will be able to find out which group your child belongs to.
Compensation for time and travel may be available. Study-related care is provided at no cost to you or your family.
What to Expect
Study participation may last up to 12 weeks and may include up to 7 in-clinic visits and up to 2 remote (phone call) visits. It is important to understand how many visits you and your child will need to attend when making the decision to participate. At the end of 12 weeks, your child may be invited to take part in a long-term extension study where all participants receive solriamfetol for an additional year.
Screening Period
(Up to 5 weeks)
This is the time when the study doctor and staff determine if your child is eligible for the study. You and your child will come in for the first visit to answer some questions and do some medical tests to see if your child may be a good fit for the study.
Study Treatment Period
(Up to 6 weeks)
If your child is eligible to continue in the study, they will then enter the study treatment period which may last up to 6 weeks and may include 6 in-clinic visits and 1 remote visit.
Your child will be randomly assigned to take either solriamfetol or placebo* once a day in the morning.
At Visit 8, your child may be invited to join a long-term extension study, where they can take solriamfetol for an additional year.
*A placebo is a pill that looks like the study medicine but does not contain any active medicine
Follow-Up Period
(Up to 1 week)
If you and your child decide not to join the long-term extension study, you and your child will be contacted via phone by the study site 1 week after the final in-person visit to check in and see how your child is doing.
At the in-person visits, you can expect some of the following assessments:
Vital Signs
ECG
Review of Medical History
Blood and Urine Samples
Health Questionnaires
Review of Any Side Effects
Why Participate?
If your child or teen has ADHD, or is suspected to have ADHD, the FOCUS-2 or FOCUS-3 study may be right for your family. If your child is eligible to participate:
- They may receive the investigational medicine
- They may receive study-related care and study evaluations at no cost
- Compensation for time and travel may be available
- You and your child may have the opportunity to help advance new options for children and teens with ADHD*
What is ADHD?
Attention Deficit Hyperactivity Disorder (ADHD) is a mental health condition that causes overactivity, inattention, impulsivity, and problems with social interaction and school performance.1 Typically, ADHD symptoms show up by age 12 and affect around 5 to 10% of school-aged children.2,3,4 ADHD is usually chronic, with 40 to 60% of cases lasting into adulthood, equaling about 2 to 5% of adults who are living with ADHD.2,5,6 Issues with other mental health conditions, poor performance at school and work, and accidents are a potential in people with ADHD.7
References
1. A. Sharma and J. Couture, “A Review of the Pathophysiology, Etiology, and Treatment of Attention-Deficit Hyperactivity Disorder (ADHD),” Annals of Pharmacotherapy, vol. 48, no. 2, pp.209–225, Feb. 2014, doi: 10.1177/1060028013510699.
2. American Psychiatric Association, Diagnostic and statistical manual of mental disorders: DSM-5, 5th ed. Washington, D.C, 2013.
3. R. Thomas, S. Sanders, J. Doust, E. Beller, and P. Glasziou, “Prevalence of attention-deficit/hyperactivity disorder: asystematic review and meta-analysis,” Pediatrics, vol. 135, no. 4, pp.e994-1001, Apr. 2015, doi: 10.1542/peds.2014-3482.
4. Fred. F. Ferri, “Attention deficit hyperactivitydisorder,” in Ferri’s Clinical Advisor 2015, St. Louis, Missouri: Mosby,2014, pp. 160–161.
5. T. J. Spencer, J. Biederman, and E. Mick, “Attention-deficit/hyperactivity disorder: diagnosis, lifespan, comorbidities, and neurobiology,” Ambul Pediatr, vol. 7, no. 1 Suppl, pp. 73–81, 2007, doi: 10.1016/j.ambp.2006.07.006.
6. S. V. Faraone, J. Biederman, and E. Mick, “The age-dependent decline of attention deficit hyperactivity disorder: ameta-analysis of follow-up studies,” Psychol Med, vol. 36, no. 2, pp.159–165, Feb. 2006, doi: 10.1017/S003329170500471X.
7. S. V. Faraone et al., “Attention-deficit/hyperactivity disorder,” Nat Rev Dis Primers, vol. 1, no. 1, p. 15020, Dec. 2015, doi: 10.1038/nrdp.2015.20.
FAQs
A clinical research study, also called a clinical trial, tests the safety and efficacy of an investigational medicine in human volunteers. Every medication on the market has gone through this process, meaning volunteers are an important part of advancing medicine for present and future generations.
Solriamfetol is the investigational oral medicine being researched in these studies. It has been approved by the U.S. Food and Drug Administration (FDA) for people who have excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea (OSA), which are sleep-related disorders. Solriamfetol is an investigational treatment for ADHD, meaning it has not yet been approved by any health authority for the treatment of ADHD. In these studies, researchers want to know if solriamfetol can improve symptoms of ADHD in children and teens and if it is safe for use in this indication and age group.
Clinical studies can be sponsored, or funded, by a pharmaceutical or biotechnology company, academic medical center, or health care provider. Every clinical study is held at one or more sites that are led by a principal investigator (study doctor) and their research team.
A placebo looks like the investigational medicine but does not contain any active ingredients (medicine). Taking placebo is as if the participant was not taking anything at all. In this study, placebo is used to compare the effects of the investigational medicine. Neither the participant nor the study doctor will know if they are taking the investigational medicine or placebo. In case of a medical emergency, the study doctor will be able to find out which group the participant belongs to.
In order to participate in a study, your child will need to first take some tests and discuss their medical history with the study doctor to ensure that they meet all criteria for participation. You, as the parent or legal guardian, will also review and sign an informed consent form which lays out what will happen in the study, you and your child’s rights and responsibilities as a participant, and the risks and potential benefits of the study. Once your child is eligible and enrolled, you will visit the study site regularly to monitor their progress and overall health.
Yes, study participation is absolutely voluntary. You have the right to end participation at any time for any reason. If you decide to drop out of the study, please speak with the study doctor first.
For more information about the FOCUS-2 study, visit Study Details | NCT07717879 | A Study to Assess the Efficacy and Safety of Solriamfetol in Children With ADHD | ClinicalTrials.gov. For more information about the FOCUS-3 study, visit Study Details | NCT07717892 | A Study to Assess the Efficacy and Safety of Solriamfetol in Adolescents With ADHD | ClinicalTrials.gov. For more information about Axsome Therapeutics, the study sponsor, visit axsome.com.