Attention-deficit/Hyperactivity DisorderPhase 4NCT07044609
A Study to Assess the Effectiveness and Safety of Clonidine Extended-Release OnydaTM XR in Children With ADHD and ODD
A Phase 4 study testing Clonidine extended release oral suspension in people with Attention-deficit/Hyperactivity Disorder and Oppositional Defiant Disorder in Children, run by Las Vegas Medical Research, LLC DBA Vector Clinical Trials.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention-deficit/Hyperactivity Disorder, Oppositional Defiant Disorder in Children
- What is being tested?
- Clonidine extended release oral suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
- Subject must live with primary caretaker/rater
- Sitting systolic and diastolic blood pressure below the 95th percentile for age, gender, and height
- Subject is functioning at age-appropriate level intellectually based on investigator's opinion
- If a female has experienced menarche, she must have a negative serum beta human chorionic gonadotropin (hCG) pregnancy test at Screening, a negative urine pregnancy test at Baseline, and agree to be abstinent from sexual activity that could result in pregnancy, or use acceptable contraceptives throughout the entire study
- Must be able to discontinue stimulants 7 days prior to Baseline and nonstimulants 14 days prior to Baseline
Who cannot join
- 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
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- 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
- Subject has participated in another clinical trial within 30 days prior to screening
- Subject has an allergy or intolerance to clonidine or OnydaTM XR
- Subject has clinically significant abnormal laboratory values at screening
- Subject has a positive drug screen at Screening, except for ADHD medications with a valid prescription
- Subject has a positive drug screen at Baseline
- Subject is currently considered a suicide risk, has previously made a suicide attempt, or has active suicidal ideation based on the Columbia Suicide Severity Rating Scale. Specifically, any positive response on C-SSRS items 4 or 5 currently at screening, or in the past 12 months, is exclusionary
- Subject has a history of a seizure disorder, except for children who have had febrile seizures prior to age 5 years
- Subjects who have been treated with clonidine or guanfacine in the past 30 days
- History of failure to respond to clonidine or guanfacine
- Subject started psychotherapy less than 30 days prior to screening
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase IV, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Effectiveness and Safety of Clonidine Extended-Release (OnydaTM XR) in Children Aged 6 to 12 Years With Attention-Deficit/ Hyperactivity Disorder and Oppositional Defiant Disorder
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.
Read more
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
Read the detailed description
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 primary objective of this study is to establish that an optimal dose of OnydaTM XR will result in a significant reduction in attention-deficit/hyperactivity disorder (ADHD) symptoms compared to placebo in children aged 6 to 12 years.
The primary efficacy measure is the 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])
The key secondary objectives include:
- Change on the Conners 4TM Oppositional Defiant Disorder Symptom Scale from Visit 2 to Visit 6
- Change from Visit 2 Baseline to Visit 6 in ADHD-RS-5 Hyperactivity/Impulsivity and Inattention subscale scores
Other secondary measures include:
- Clinical Global Impression Severity Scale change from Visit 2 (Baseline) to Visit 6 (End of Double-blind Treatment [ 0.2 mg treatment])
- Clinical Global Impression Change Scale change from Visit 2 (Baseline) to Visit 6 (End of Double-blind Treatment [ 0.2 mg treatment])
- Children's Sleep Habits Questionnaire (CSHQ)
Safety and tolerability of OnydaTM XR:
- Changes in Blood Pressure, Pulse, Height, and Weight
- Columbia Suicide Severity Rating Scale (C-SSRS)
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 there will be a phone call to the participant to determine if any adverse events resolved.
- Being tested
- Clonidine extended release oral suspension, Placebo
- Keywords
- ADHD, ODD, oppositional defiant disorder
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Oppositional Defiant Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clonidine extended release oral suspensionDrug
The study is blinded and the active clonidine extended-release oral suspension will look just like the placebo comparator.
PlaceboDrug
Placebo suspension
| Study group | Role | What they receive |
|---|---|---|
| Extended-release clonidine oral suspension | Active comparator | Participants in this arm will start on 0.1 mg of clonidine extended-release oral suspension and titrate to 0.2 mg of clonidine extended release oral suspension. Receives: Drug: Clonidine extended release oral suspension |
| Placebo suspension | Placebo comparator | Participants in this arm will receive a placebo oral-suspension throughout the study. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]).
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]).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double-blind, placebo-controlled, parallel-group study. Subjects will be assigned 1:1 to drug or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Las Vegas Medical Research, LLC DBA Vector Clinical Trials
- Sponsor type
- University, hospital or other
- Collaborators
- Tris Pharma, Inc.
- Responsible party
- Sponsor
- Investigators
- Ann Childress, MD, Principal investigator, Vector Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044609
- Sponsor's protocol ID
- ADHD-01
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This is a single site study.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Effectiveness and Safety of Clonidine Extended-Release (OnydaTM XR) in Children Aged 6 to 12 Years With Attention-Deficit/ Hyperactivity Disorder and Oppositional Defiant Disorder
- ClinicalTrials.gov ID
- NCT07044609
- Acronym / sponsor ID
- ADHD-01
- Keywords
- ADHD, ODD, oppositional defiant disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Las Vegas Medical Research, LLC DBA Vector Clinical TrialsUniversity, hospital or other
- Collaborators
- Tris Pharma, Inc.
- Study start
- Jul 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 primary objective of this study is to establish that an optimal dose of OnydaTM XR will result in a significant reduction in attention-deficit/hyperactivity disorder (ADHD) symptoms compared to placebo in children aged 6 to 12 years.
The primary efficacy measure is the 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])
The key secondary objectives include:
- Change on the Conners 4TM Oppositional Defiant Disorder Symptom Scale from Visit 2 to Visit 6
- Change from Visit 2 Baseline to Visit 6 in ADHD-RS-5 Hyperactivity/Impulsivity and Inattention subscale scores
Other secondary measures include:
- Clinical Global Impression Severity Scale change from Visit 2 (Baseline) to Visit 6 (End of Double-blind Treatment [ 0.2 mg treatment])
- Clinical Global Impression Change Scale change from Visit 2 (Baseline) to Visit 6 (End of Double-blind Treatment [ 0.2 mg treatment])
- Children's Sleep Habits Questionnaire (CSHQ)
Safety and tolerability of OnydaTM XR:
- Changes in Blood Pressure, Pulse, Height, and Weight
- Columbia Suicide Severity Rating Scale (C-SSRS)
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 there will be a phone call to the participant to determine if any adverse events resolved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, placebo-controlled, parallel-group study. Subjects will be assigned 1:1 to drug or placebo.
| Arm | Type | Receives |
|---|---|---|
| Extended-release clonidine oral suspension | Active comparator | Drug: Clonidine extended release oral suspensionParticipants in this arm will start on 0.1 mg of clonidine extended-release oral suspension and titrate to 0.2 mg of clonidine extended release oral suspension. |
| Placebo suspension | Placebo comparator | Drug: PlaceboParticipants in this arm will receive a placebo oral-suspension throughout the study. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clonidine extended release oral suspensionThe study is blinded and the active clonidine extended-release oral suspension will look just like the placebo comparator. | Drug | Extended-release clonidine oral suspension |
| PlaceboPlacebo suspension | Drug | Placebo suspension |
Primary outcome
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]).
Time frame: 4 weeks
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]).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No. This is a single site study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ann Childress, MD principal investigator
Vector Clinical Trials
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clonidine extended release oral suspension in people with Attention-deficit/Hyperactivity Disorder and Oppositional Defiant Disorder in Children, run by Las Vegas Medical Research, LLC DBA Vector Clinical Trials.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ann Childress, MD (702-750-0000, drann87@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]). (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.