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
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.
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
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:
Other secondary measures include:
Safety and tolerability of OnydaTM XR:
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.
Inclusion Criteria:
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
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
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