Full Text View
Tabular View
No Study Results Posted
Related Studies
Study Evaluating the Safety and Efficacy of CLONICEL® to Treat Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
This study has been completed.
First Received: November 8, 2007   Last Updated: August 11, 2008   History of Changes
Sponsor: Addrenex Pharmaceuticals, Inc.
Information provided by: Addrenex Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00556959
  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 III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
1: Experimental
CLONICEL High Dose
Drug: high dose clonidine HCl sustained release
high dose clonidine HCl sustained release tablets for 8 weeks
2: Experimental
CLONICEL Low Dose
Drug: low dose clonidine HCl sustained release
low dose clonidine HCl sustained release tablets for 8 weeks
3: Placebo Comparator
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00556959

Locations
United States, Florida
Gainesville, Florida, United States, 32607
Orlando, Florida, United States, 32806
Jacksonville, Florida, United States, 32216
Miami, Florida, United States, 33161
United States, Michigan
Rochester Hills, Michigan, United States, 48307
United States, New Jersey
Voorhees, New Jersey, United States, 08043
Clementon, New Jersey, United States, 08021
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
Lake Jackson, Texas, United States, 77566
Houston, Texas, United States, 77007
Sponsors and Collaborators
Addrenex Pharmaceuticals, Inc.
Investigators
Study Director: Moise A Khayrallah, PhD Addrenex Pharmaceuticals, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Addrenex Pharmaceuticals ( Moise Khayrallah, PhD / President & CEO )
Study ID Numbers: CLON-301
Study First Received: November 8, 2007
Last Updated: August 11, 2008
ClinicalTrials.gov Identifier: NCT00556959     History of Changes
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:
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic Agonists
Signs and Symptoms
Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Sensory System Agents
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Analgesics
Sympatholytics
Adrenergic alpha-Agonists
Disease
Clonidine
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Cardiovascular Agents
Antihypertensive Agents
Dyskinesias
Pharmacologic Actions
Autonomic Agents
Neurologic Manifestations
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010