About the Study
Please note: This trial has finished recruiting and is not accepting new participants.
Research Center: Qualmedica Research, LLC
Location 1: 920 Frederica Street, Ste. 1010, Owensboro, KY 42301
Location 2: 615 7th Avenue, Bowling Green, KY 42101
Lead Researcher for Owensboro: J. Christopher Sartore, MD
Lead Researcher for Bowling Green: Kelly Kries, MD
IRB Committee: This study has been reviewed and approved by the WCG Institutional Review Board
Does your child have ADHD? ADHD affects more than 6 million U.S. children. About 30% of people with ADHD do not respond or cannot tolerate stimulant medications. And there are times that management would require behavioral modification therapy. ADHD can significantly impact a child’s quality of life. It can also be a challenge for parents and teachers to manage.
If there is a safe and effective non-stimulant medication, it will provide an alternative therapy for millions of kids and teens who suffer from ADHD. This is why Qualmedica Research, LLC is doing a study that focuses on ADHD treatment. This research study seeks to understand the effectiveness of a non-stimulant medication that may help treat and manage ADHD among children and adolescents who have been unresponsive to or cannot tolerate stimulant medications.
If you think your child could benefit from this study as well as help advance research, read on!
- If you decide that your child would participate in this study and later feel that you or your child no longer wishes to be part of it, you can withdraw from the study at any time.
- Any information that you provide will be kept strictly confidential, except as required by law.
- Qualified health professionals will monitor your child’s health as it relates to the study.
Who Can Join This Study?
- Children and adolescents aged 6-17 years old who have been diagnosed with ADHD
- Must be able to swallow intact tablets and capsules
- Must have had stimulant therapy in the past but it was either not suitable, not well tolerated or was ineffective in treating their ADHD
- Must be able to attend 17 study visits at the research site over approximately 1 year
Key Study Details
The study team will explain the research study in its entirety but some details are:
- There are 2 sites in Kentucky conducting this study, one in Owensboro and one in Bowling Green.
- Participation in this study requires parental and/or legal guardian consent
- Participation in this study involves taking the study medication in capsules and/or tablets.
What Else Should I Know About This Study?
- Your child may receive an alternative treatment for ADHD at no cost.
- Your child will be helping to advance ADHD treatment research that may benefit other kids and teens with ADHD in the future.
- Your child may be compensated in gift cards for participating in this study. Compensation will be provided to any patient who arrives for a study visit.
About the Research Center
Qualmedica Research, LLC
Qualmedica Research is a multi-site clinical research company offering clinical trials in Indiana and Kentucky, USA. They have provided high quality, compliant research since 1996. Their goal is to deliver exceptional service to drug sponsors, collaborative project support to physicians and Contract Research Organizations (CRO), and empathetic care to our patient volunteers. Their mission is to enable better health for patients that will benefit from new or improved drugs. They partner with physicians and sponsors to bring therapeutics to market that are safe, effective, and meaningful to a patient’s quality of life. They are dedicated to improving health through research.
Due to the COVID-19 pandemic, the researchers would like to assure the participants that ensuring their and the study staff’s safety is of utmost importance.