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

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 Overview

• Status: Completed
• Conditions: Attention Deficit Disorder With Hyperactivity
• Intervention / Treatment: Drug: high dose clonidine HCl sustained release; Drug: low dose clonidine HCl sustained release; Drug: placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 236
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32607
    • Jacksonville, Florida, United States, 32216
    • Miami, Florida, United States, 33161
    • Orlando, Florida, United States, 32806
  • Michigan
    • Rochester Hills, Michigan, United States, 48307
  • New Jersey
    • Clementon, New Jersey, United States, 08021
    • Voorhees, New Jersey, United States, 08043
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
    • Charlotte, North Carolina, United States, 28209
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
    • Oklahoma City, Oklahoma, United States, 73116
  • Texas
    • Houston, Texas, United States, 77007
    • Lake Jackson, Texas, United States, 77566

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ADHDRS-IV	Week 5

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Addrenex Pharmaceuticals, Inc.
• Investigators: Study Director: Moise A Khayrallah, PhD, Addrenex Pharmaceuticals, Inc.

Publications and helpful links

General Publications

• Jain R, Segal S, Kollins SH, Khayrallah M. Clonidine extended-release tablets for pediatric patients with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2011 Feb;50(2):171-9. doi: 10.1016/j.jaac.2010.11.005.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: November 8, 2007
• First Submitted That Met QC Criteria: November 9, 2007
• First Posted (Estimate): November 12, 2007

Study Record Updates

• Last Update Posted (Estimate): March 24, 2010
• Last Update Submitted That Met QC Criteria: March 23, 2010
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: ADHD; Clonidine; Hyperactivity; Attention Deficit; CLONICEL; Addrenex
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympatholytics; Clonidine
• Other Study ID Numbers: CLON-301