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

NCT ID: NCT00556959

Last Updated: 2010-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-08-31

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).

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

CLONICEL High Dose

Group Type: EXPERIMENTAL

high dose clonidine HCl sustained release

Intervention Type: DRUG

high dose clonidine HCl sustained release tablets for 8 weeks

2

CLONICEL Low Dose

Group Type: EXPERIMENTAL

low dose clonidine HCl sustained release

Intervention Type: DRUG

low dose clonidine HCl sustained release tablets for 8 weeks

3

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo tablets for 8 weeks

Interventions

high dose clonidine HCl sustained release

high dose clonidine HCl sustained release tablets for 8 weeks

Intervention Type: DRUG

low dose clonidine HCl sustained release

low dose clonidine HCl sustained release tablets for 8 weeks

Intervention Type: DRUG

placebo

placebo tablets for 8 weeks

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Addrenex Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Addrenex Pharmaceuticals

Principal Investigators

Moise A Khayrallah, PhD

Role: STUDY_DIRECTOR

Addrenex Pharmaceuticals, Inc.

Locations

Gainesville, Florida, United States

Jacksonville, Florida, United States

Miami, Florida, United States

Orlando, Florida, United States

Rochester Hills, Michigan, United States

Clementon, New Jersey, United States

Voorhees Township, New Jersey, United States

Chapel Hill, North Carolina, United States

Charlotte, North Carolina, United States

Oklahoma City, Oklahoma, United States

Oklahoma City, Oklahoma, United States

Houston, Texas, United States

Lake Jackson, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 21241954 (View on PubMed)

Other Identifiers

CLON-301

Identifier Type: -

Identifier Source: org_study_id