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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00556959
Recruitment Status : Completed
First Posted : November 12, 2007
Last Update Posted : March 24, 2010
Information provided by:
Addrenex Pharmaceuticals, Inc.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Drug: high dose clonidine HCl sustained release Drug: low dose clonidine HCl sustained release Drug: placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Arm Intervention/treatment
Experimental: 1
Drug: high dose clonidine HCl sustained release
high dose clonidine HCl sustained release tablets for 8 weeks

Experimental: 2
Drug: low dose clonidine HCl sustained release
low dose clonidine HCl sustained release tablets for 8 weeks

Placebo Comparator: 3
Drug: placebo
placebo tablets for 8 weeks

Primary Outcome Measures :
  1. ADHDRS-IV [ Time Frame: Week 5 ]

Secondary Outcome Measures :
  1. CPRS-L, CGI-S, and CGI-I [ Time Frame: Week 5 ]
  2. Adverse Events, Laboratory Assessments, Vital Signs, and ECGs [ Time Frame: Throughout Treatment Phase ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00556959

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United States, Florida
Gainesville, Florida, United States, 32607
Jacksonville, Florida, United States, 32216
Miami, Florida, United States, 33161
Orlando, Florida, United States, 32806
United States, Michigan
Rochester Hills, Michigan, United States, 48307
United States, New Jersey
Clementon, New Jersey, United States, 08021
Voorhees, New Jersey, United States, 08043
United States, North Carolina
Chapel Hill, North Carolina, United States, 27514
Charlotte, North Carolina, United States, 28209
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73103
Oklahoma City, Oklahoma, United States, 73116
United States, Texas
Houston, Texas, United States, 77007
Lake Jackson, Texas, United States, 77566
Sponsors and Collaborators
Addrenex Pharmaceuticals, Inc.
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Study Director: Moise A Khayrallah, PhD Addrenex Pharmaceuticals, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Moise Khayrallah, PhD / President & CEO, Addrenex Pharmaceuticals Identifier: NCT00556959     History of Changes
Other Study ID Numbers: CLON-301
First Posted: November 12, 2007    Key Record Dates
Last Update Posted: March 24, 2010
Last Verified: August 2008

Keywords provided by Addrenex Pharmaceuticals, Inc.:
Attention Deficit

Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action