We’re inviting your child to join the Cottage Study, for children between the ages of 6 to 12 years old with ADHD.
The Cottage Study is evaluating an investigational drug as a possible treatment for ADHD. There is no cost for receiving any study-related drugs during the course of the study.
The Cottage Study may be right for your child if they:
The Cottage Study will enroll about 450 participants with ADHD at approximately 50 research study sites in the United States and Canada.
The study will include approximately 9 visits to a study site and 1 telephone call over about 11 weeks.
All study-related visits, tests, and investigational drug/placebo will be provided at no cost. In addition, reimbursement for study-related travel may be provided.
The Cottage Study is evaluating an investigational drug as a possible treatment for ADHD. There is no cost for receiving the investigational drug/placebo during the course of the study.
Your child may qualify for the Cottage Study if they:
What happens if I sign up? We will match your child to a study location in your area that is enrolling participants with ADHD or notify you when one becomes available.
To find out if the Cottage Study is right for your child, we need to collect some initial information from you about your child’s ADHD. If the information you provide indicates that the study may be right for your child, someone from the study site will contact you to discuss next steps and provide additional information about study qualification and participation. Keep in mind that participation is entirely voluntary. If your child does decide to take part in the study, they may change their mind about participating at any time.
Attention-deficit/hyperactivity disorder (ADHD) is an increasingly recognized disorder characterized by 3 core symptoms of hyperactivity, inattentiveness, and impulsivity.1 Depending on the ADHD subtype, sex of the individual, and presence of comorbid disorders, individuals with ADHD may display considerably different symptomatology, even within a particular age group.2
ADHD is typically viewed as a childhood/adolescent disorder3. ADHD frequently begins between 2 and 4 years of age4,5 and it is typically diagnosed between ages 7 and 10 years. Because inattention, impulsivity, and hyperactivity can all be normal behaviors for a young child, making a diagnosis of ADHD often requires the degree and impairment of these symptoms to be beyond what is developmentally appropriate.6 In addition, symptoms of ADHD, even at a young age, are frequently associated with social impairment, such as emotional distress for the child and the parents.7
Despite how common ADHD is, there are limited treatment options, meaning there is a need for new treatments.
The Cottage Study is evaluating an investigational drug as a possible treatment for ADHD. There is no cost for receiving care during the course of the study.
A Clinical Research Study (also called a study) is a study that helps to answer important questions about an investigational drug – these may include how well an investigational drug works for a certain condition. All drugs must be tested in clinical research studies before they can be approved and prescribed to patients.
A study is the process by which new and innovative drugs, interventions and treatments are approved and brought to market and made available for people with different health conditions. Even over-the-counter drugs, such as Ibuprofen or Acetaminophen, which you may have used to counteract a headache, have gone through the clinical study process before it was available at your local pharmacy.
The Cottage Study is evaluating an investigational drug. An investigational drug is being studied as a possible treatment for Attention-deficit/Hyperactivity Disorder (ADHD). Permission for this study has been granted by the United States Food and Drug Administration (FDA). The investigational drug is not available for sale in the United States or Canada. The purpose of this study is to find out the potential benefits and safety of the investigational drug being studied.
Participants will receive either the investigational drug or a placebo in this study. A placebo is an inactive material that looks like the investigational drug but does not contain any active drug. Researchers use a placebo to see if the investigational drug works better or is safer than taking nothing. By having one group of participants take a placebo and another group of participants take the investigational drug, researchers can measure if the drug works by comparing how both groups react.
If the study doctor decides that your child meets all of the requirements to be in this study, they will be randomly assigned (like drawing straws) to one of three participant groups. Approximately 2 out of 3 participants will receive the investigational drug. Approximately 1 out of 3 participants will receive placebo. The participant group that your child is assigned to will not be known by your child, you, the study doctor, or the study site staff.
About 450 participants will participate in the study. The study is being done at about 50 study sites in the United States and Canada.
If your child chooses to take part in this study, they will have about 10 study visits (9 office visits and 1 telephone visit) over 11 weeks (just under 3 months).
Those who take part in the study may receive reimbursement for travel expenses related to study participation. Please discuss this with the study site staff when they contact you.
There is no cost to participate in the Cottage Study. If your child does take part:
The study doctor and staff at the study site will be able to explain more about what the Cottage Study will involve, and it is up to you and your child to decide if you want to take part. Participation in this study is voluntary. Whether or not you and your child to decide to participate in this study will not affect current or future relationships with your doctors. If you decide to participate, you and your child are free to leave the study at any time without affecting those relationships.
We match 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 your child 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 child’s information stored, you can opt out and we will delete their details.