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

Information source: Addrenex Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Attention Deficit Disorder With Hyperactivity

Intervention: high dose clonidine HCl sustained release (Drug); low dose clonidine HCl sustained release (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Addrenex Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
Moise A Khayrallah, PhD, Study Director, Affiliation: Addrenex Pharmaceuticals, Inc.


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).

Clinical Details

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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: ADHDRS-IV

Secondary outcome:


Adverse Events, Laboratory Assessments, Vital Signs, and ECGs

Detailed description: 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.


Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.


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.

Locations and Contacts

Gainesville, Florida 32607, United States

Jacksonville, Florida 32216, United States

Miami, Florida 33161, United States

Orlando, Florida 32806, United States

Rochester Hills, Michigan 48307, United States

Clementon, New Jersey 08021, United States

Voorhees, New Jersey 08043, United States

Chapel Hill, North Carolina 27514, United States

Charlotte, North Carolina 28209, United States

Oklahoma City, Oklahoma 73103, United States

Oklahoma City, Oklahoma 73116, United States

Houston, Texas 77007, United States

Lake Jackson, Texas 77566, United States

Additional Information

Starting date: October 2007
Last updated: March 23, 2010

Page last updated: August 20, 2015

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