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

Attention Deficit Disorder With Hyperactivity Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00556959
• Other study ID #: CLON-301
• Status: Completed
• Phase: Phase 3
• First received: November 8, 2007
• Last updated: March 23, 2010
• Start date: October 2007
• Est. completion date: August 2008

Study information

• Verified date: August 2008
• Source: Addrenex Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Drug:
• high dose clonidine HCl sustained release
high dose clonidine HCl sustained release tablets for 8 weeks
• low dose clonidine HCl sustained release
low dose clonidine HCl sustained release tablets for 8 weeks
• placebo
placebo tablets for 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Addrenex Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHDRS-IV		Week 5	No
Secondary	CPRS-L, CGI-S, and CGI-I		Week 5	No
Secondary	Adverse Events, Laboratory Assessments, Vital Signs, and ECGs		Throughout Treatment Phase	Yes