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If you’re like most people with ADHD, starting a project is rarely the problem. The challenge is seeing it through to the end. Because of ADHD, your focus and attention jump to and from other things and thoughts, making it hard to stay on task. The NeuroScience research study is being conducted to explore additional adult ADHD treatment options. In the study, doctors are evaluating an oral investigational drug to see if it helps treat symptoms in adults with ADHD over a year-long period. This investigational drug has not been approved in any country to treat adult ADHD and is only available in research studies like this one. Study doctors want to learn more about the long-term safety and effectiveness of the investigational drug.
The results of this study will provide more information about whether the investigational drug could one day be approved by the United States Food and Drug Administration (FDA) to treat ADHD. If you completed either the CROWN or CAPSTONE study, you are already familiar with the investigational drug and how research studies work. However, in this study, there is no placebo, as all study participants will receive the active investigational drug. Other than the length of the NeuroScience research study, your participation will be similar to that of the CROWN or CAPSTONE study.
Who is eligible to participate in the NeuroScience Research Institute study? To pre-qualify for this study, you must:
All study-related visits, tests, and study drugs will be provided at no cost. In addition, reimbursement for study-related travel may be provided.
If you are eligible for this study and agree to participate, you will receive the investigational drug. You will take your dose of the investigational drug twice a day, with or without food, for 52 weeks. You will also come to the study clinic approximately 17 times to be evaluated by the study doctor and study staff. After your last dose of the investigational drug, you will visit the clinic two times and also receive four follow-up phone calls over the course of 10 days. Your total study participation will last up to 56 weeks, which includes screening for eligibility, treatment, and follow-up.
As with any research study, you may not benefit from participating in this study. However, your participation may help ADHD patients in the future. It is also possible you could experience one or more side effects during this study. Before you join the study, the study staff will talk with you about all known study-related risks and side effects. Because this study can affect your health, you will be monitored closely. The sponsor of this study was required to design a protocol. All of the methods and procedures outlined in the protocol were reviewed by an Independent Review Board (IRB). An IRB ensures appropriate safeguards exist to protect the rights and welfare of research subjects.
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