A Study to Assess the Effectiveness and Safety of Clonidine Extended-Release OnydaTM XR in Childr… (NCT07044609) | Clinical Trial Compass
Not Yet RecruitingPhase 4
A Study to Assess the Effectiveness and Safety of Clonidine Extended-Release OnydaTM XR in Children With ADHD and ODD
162 participantsStarted 2025-07
Plain-language summary
This is a study to see how safe and effective OnydaTM XR is to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6 to 12 years who also have Oppositional Defiant Disorder (ODD). The trial will consist of a screening period of up to 28 days; a 35-day double-blind treatment period that includes a one week of the lowest dose of medication (0.1mg) given at bedtime, then three weeks at 0.2 mg, then one week at 0.1 mg and a follow-up phone call one week after stopping study medication. During the screening period, we will determine whether participants qualify to enroll in the study.
Approximately 162 boys and girls aged 6 to 12 years, who are currently diagnosed with ADHD and ODD, are planned to be screened in order to complete approximately 124 subjects.
Key Inclusion/Exclusion Criteria Participants will have a main diagnosis of ADHD and comorbid ODD based on a structured interview. They will also be required to have significant problems because of their ADHD and be in good health. They will not be able to take other medications for ADHD or any other mental health problems during the study.
At the screening visit, participants and their parents will be asked about ADHD, ODD and other mental health symptoms. They will also give blood and urine samples, and complete an electrocardiogram and physical exam. Blood pressure and pulse rate will also be obtained. Parents will complete questionnaires about ADHD, ODD, and sleep.
During the second visit, the doctor will ensure that participants continue to qualify for the study. Parents and participants will complete questionnaires. Parents will be shown how to dose the study medication. It is a liquid suspension.
Participants will be seen weekly and will be asked about changes in health, new medications and parents will complete questionnaires while participants have blood pressure and pulse rate checked.
At the last in-clinic study visit, participants will also have blood and urine samples taken and, complete an electrocardiogram and undergo a physical exam. Parents will complete questionnaires.
One week after the last in-clinic visit
Who can participate
Age range
6 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and female subjects aged 6 to 12 years of age inclusive at time of consent
. Meets DSM-5 criteria for ADHD, combined, hyperactive/impulsive or inattentive presentation using a clinical interview by an experienced clinician and confirmed with the Mini-International Neuropsychiatric Interview for children and adolescents (MINI-KID)
. Meets DSM-5 criteria for Oppositional Defiant Disorder confirmed with the MINI-KID
. The subject has a parent or legal guardian who will give written informed consent for the subject to participate in the study
. Subject and parent/legal guardian must be able to speak, read, write, and understand English
. Subject and parent/legal guardian must agree to comply with all protocol requirements
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the ADHD-RS-5 (Investigator Scored) Total Score from Visit 2 (Baseline) to Visit 6 (End of Double-blind Treatment [0.2 mg treatment]).
Timeframe: 4 weeks
Trial details
NCT IDNCT07044609
SponsorLas Vegas Medical Research, LLC DBA Vector Clinical Trials
. ADHD-RS-5 score of ≥28 at Screening and Baseline if not taking ADHD medications. If taking ADHD medication, must have ADHD-RS-5 score of ≥28 after washout at Baseline
. Subject has a CGI-S score of ≥4 at Screening if not taking ADHD medication. If taking ADHD medication must have CGI-S score of ≥4 at Baseline
Exclusion criteria
. Subject has a current severe comorbid psychiatric condition (except oppositional defiant disorder \[ODD\]) that is controlled (requiring a prohibited medication or behavioral modification program) or uncontrolled. These conditions include comorbid disorders, such as bipolar illness, psychosis, autism spectrum disorder, post-traumatic stress disorder, obsessive-compulsive disorder, substance use disorder, or conduct disorder, that in the opinion of the Investigator, contraindicate treatment with OnydaTM XR, or confound efficacy or safety assessments
. Use of another investigational drug in the 30 days prior to screening
. Use of anticonvulsants, antidepressants, or antipsychotics in the 30 days prior to screening
. History (in the past 12 months) or presence of clinically significant cardiovascular, cerebrovascular, renal, hepatic, gastrointestinal, pulmonary, immunological, hematological, endocrine, or neurological disease, that in the opinion of the investigator, could put the subject at risk if he/she participates in the trial, or confound study results
. History of presence of suicidal ideation or self-injurious behavior
. Subject has orthostatic hypotension or history of hypertension
. Subject has clinically significant ECG findings as judged by the investigator.
. Subject has a QTc-Fridericia (QTc-F) \> 450 ms in males or \> 470 ms in females at screening