Study Evaluating the Safety and Efficacy of CLONICEL® to Treat Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether CLONICEL® (clonidine HCl sustained release) is a safe and effective treatment for children and adolescents with attention deficit hyperactivity disorder (ADHD).

Detailed Description
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Clonidine is a centrally acting alpha2 adrenergic agonist that has been used effectively since the early 70s to treat mild to moderate hypertension. In addition to hypertension, clonidine has been evaluated and used extensively for several other indications, including attention deficit hyperactivity disorder (ADHD). An easy to administer clonidine formulation is needed that retains the efficacy of the current oral formulation but has an improved safety profile. The current trial will investigate the safety and efficacy of clonidine delivered from the sustained release formulation of CLONICEL in the treatment of children and adolescents with ADHD.

Official Title
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A Phase III, Dose-Response Evaluation of the Efficacy and Safety of CLONICEL® (Clonidine HCl Sustained Release) vs. Placebo in the Treatment of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)

Conditions
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Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
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* Drug: high dose clonidine HCl sustained release
* Drug: low dose clonidine HCl sustained release
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female between 6 and 17 years of age, inclusive Diagnosis of ADHD of the hyperactive or combined inattentive/hyperactive subtypes according to DSM-IV criteria Minimum score of 26 on the ADHDRS-IV questionnaire at Baseline General good health as judged by the Principal Investigator Body mass index ≥ 5th percentile of the subject's age group according to the CDC growth chart. Ability to swallow tablets General IQ ≥80 as judged by the Principal Investigator Subject as well as parent/guardian able to sign informed assent or consent form. Exclusion Criteria: If female of child-bearing potential, pregnant or lactating or does not agree to use a medically acceptable form of birth control, such as hormonal medication, double-barrier method, or IUD Presence of a clinically significant illness or abnormality on physical examination or clinical laboratory evaluations that, in the opinion of the investigator, would increase the safety risks from clonidine administration or interfere with the ability of the patient to take part in the study. Presence of clinically significant abnormality on centrally interpreted Electrocardiogram (ECG) readings History or presence of a concomitant psychiatric disorder requiring psychotropic medication or a severe concomitant Axis I or Axis II disorder that could interfere with study assessments in the judgment of the Principal Investigator History of concomitant conduct disorder (CD) History of seizures, except for a single episode of febrile seizure prior to age 2 History of syncopal episodes Presence of a disorder that would interfere with the absorption, metabolism, or excretion of clonidine History of intolerance to clonidine, including any dermatologic reaction to transdermal clonidine Presence or history of alcohol or drug abuse Positive drug screen, with the exception of ADHD drugs Use of any investigational drug within 30 days of study start.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>CLONICEL High Dose | Drug: high dose clonidine HCl sustained release<br>* high dose clonidine HCl sustained release tablets for 8 weeks<br>|
| Experimental: 2<br>CLONICEL Low Dose | Drug: low dose clonidine HCl sustained release<br>* low dose clonidine HCl sustained release tablets for 8 weeks<br>|
| Placebo Comparator: 3<br>Placebo | Drug: placebo<br>* placebo tablets for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHDRS-IV |  | Week 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPRS-L, CGI-S, and CGI-I |  | Week 5 | 
| Adverse Events, Laboratory Assessments, Vital Signs, and ECGs |  | Throughout Treatment Phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Clonidine, Attention Deficit, Hyperactivity, CLONICEL, Addrenex