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

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

high dose clonidine HCl sustained release

low dose clonidine HCl sustained release

placebo

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring ADHD, Clonidine, Attention Deficit, Hyperactivity, CLONICEL, Addrenex

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

CLONICEL High Dose

CLONICEL Low Dose

Placebo

Outcomes

Primary Outcome Measures

ADHDRS-IV

Secondary Outcome Measures

CPRS-L, CGI-S, and CGI-I

Adverse Events, Laboratory Assessments, Vital Signs, and ECGs

Full Information

NCT ID

NCT00556959

First Posted

November 8, 2007

Last Updated

March 23, 2010

Sponsor

Addrenex Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00556959

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Addrenex Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Disorder With Hyperactivity

Keywords

ADHD, Clonidine, Attention Deficit, Hyperactivity, CLONICEL, Addrenex

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

236 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

CLONICEL High Dose

Arm Title

Arm Type

Experimental

Arm Description

CLONICEL Low Dose

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

high dose clonidine HCl sustained release

Intervention Description

high dose clonidine HCl sustained release tablets for 8 weeks

Intervention Type

Drug

Intervention Name(s)

low dose clonidine HCl sustained release

Intervention Description

low dose clonidine HCl sustained release tablets for 8 weeks

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

placebo tablets for 8 weeks

Primary Outcome Measure Information:

Title

ADHDRS-IV

Time Frame

Week 5

Secondary Outcome Measure Information:

Title

CPRS-L, CGI-S, and CGI-I

Time Frame

Week 5

Title

Adverse Events, Laboratory Assessments, Vital Signs, and ECGs

Time Frame

Throughout Treatment Phase

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Moise A Khayrallah, PhD

Organizational Affiliation

Addrenex Pharmaceuticals, Inc.

Official's Role

Study Director

Facility Information:

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

Country

United States

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

City

Miami

State/Province

Florida

ZIP/Postal Code

33161

Country

United States

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

City

Rochester Hills

State/Province

Michigan

ZIP/Postal Code

48307

Country

United States

City

Clementon

State/Province

New Jersey

ZIP/Postal Code

08021

Country

United States

City

Voorhees

State/Province

New Jersey

ZIP/Postal Code

08043

Country

United States

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27514

Country

United States

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28209

Country

United States

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73116

Country

United States

City

Houston

State/Province

Texas

ZIP/Postal Code

77007

Country

United States

City

Lake Jackson

State/Province

Texas

ZIP/Postal Code

77566

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21241954

Citation

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.

Results Reference

derived

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

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