Official Title: “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)”

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).

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2008

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.

Intervention(s) in this Clinical Trial

• Drug: high dose clonidine HCl sustained release
  • high dose clonidine HCl sustained release tablets for 8 weeks
• Drug: low dose clonidine HCl sustained release
  • low dose clonidine HCl sustained release tablets for 8 weeks
• Drug: placebo
  • placebo tablets for 8 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • CLONICEL High Dose
• Experimental: 2
  • CLONICEL Low Dose
• Placebo Comparator: 3
  • Placebo

Primary Measures

• ADHDRS-IV
  • Time Frame: Week 5
    Safety Issue?: No

Secondary Measures

• CPRS-L, CGI-S, and CGI-I
  • Time Frame: Week 5
    Safety Issue?: No
• Adverse Events, Laboratory Assessments, Vital Signs, and ECGs
  • Time Frame: Throughout Treatment Phase
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Addrenex Pharmaceuticals, Inc.

Overall Clinical Trial Officials and Contacts

Moise A Khayrallah, PhD Study Director Addrenex Pharmaceuticals, Inc.  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00556959

Study ID Number: CLON-301

ClinicalTrials.gov Identifier: NCT00556959

Health Authority: United States: Food and Drug Administration

Addrenex Pharmaceuticals