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

November 8, 2007
March 23, 2010
October 2007
August 2008   (final data collection date for primary outcome measure)
ADHDRS-IV [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
ADHDRS-IV [ Time Frame: Week 5 ]
Complete list of historical versions of study NCT00556959 on ClinicalTrials.gov Archive Site
  • 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 ]
  • CPRS-L, CGI-S, and CGI-I [ Time Frame: Week 5 ]
  • Adverse Events, Laboratory Assessments, Vital Signs, and ECGs [ Time Frame: Throughout Treatment Phase ]
Not Provided
Not Provided
 
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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Attention Deficit Disorder With Hyperactivity
  • Drug: high dose clonidine HCl sustained release
    high dose clonidine HCl sustained release tablets for 8 weeks
  • Drug: low dose clonidine HCl sustained release
    low dose clonidine HCl sustained release tablets for 8 weeks
  • Drug: placebo
    placebo tablets for 8 weeks
  • Experimental: 1
    CLONICEL High Dose
    Intervention: Drug: high dose clonidine HCl sustained release
  • Experimental: 2
    CLONICEL Low Dose
    Intervention: Drug: low dose clonidine HCl sustained release
  • Placebo Comparator: 3
    Placebo
    Intervention: Drug: placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
236
August 2008
August 2008   (final data collection date for primary outcome measure)

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.
Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00556959
CLON-301
No
Moise Khayrallah, PhD / President & CEO, Addrenex Pharmaceuticals
Addrenex Pharmaceuticals, Inc.
Not Provided
Study Director: Moise A Khayrallah, PhD Addrenex Pharmaceuticals, Inc.
Addrenex Pharmaceuticals, Inc.
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP