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

This study has been completed.
Sponsor:
Information provided by:
Addrenex Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00556959
First received: November 8, 2007
Last updated: March 23, 2010
Last verified: August 2008
  Purpose

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 Intervention Phase
Attention Deficit Disorder With Hyperactivity
Drug: high dose clonidine HCl sustained release
Drug: low dose clonidine HCl sustained release
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Addrenex Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • ADHDRS-IV [ Time Frame: Week 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CPRS-L, CGI-S, and CGI-I [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
  • Adverse Events, Laboratory Assessments, Vital Signs, and ECGs [ Time Frame: Throughout Treatment Phase ] [ Designated as safety issue: Yes ]

Enrollment: 236
Study Start Date: October 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: 3
Placebo
Drug: placebo
placebo tablets for 8 weeks

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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556959

Locations
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, 73116
Oklahoma City, Oklahoma, United States, 73103
United States, Texas
Houston, Texas, United States, 77007
Lake Jackson, Texas, United States, 77566
Sponsors and Collaborators
Addrenex Pharmaceuticals, Inc.
Investigators
Study Director: Moise A Khayrallah, PhD Addrenex Pharmaceuticals, Inc.
  More Information

No publications provided by Addrenex Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Moise Khayrallah, PhD / President & CEO, Addrenex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00556959     History of Changes
Other Study ID Numbers: CLON-301
Study First Received: November 8, 2007
Last Updated: March 23, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Addrenex Pharmaceuticals, Inc.:
ADHD
Clonidine
Attention Deficit
Hyperactivity
CLONICEL
Addrenex

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Clonidine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Antihypertensive Agents
Autonomic Agents
Cardiovascular Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sympatholytics
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014