Back to resultsOpen-Label, Chronic Exposure, Safety Study of CLONICEL (Clonidine HCl Sustained Release) in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CLONICEL (Clonidine HCl sustained release)
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring CLONICEL, Attention Deficit Hyperactivity Disorder, clonidine HCl sustained release
Eligibility Criteria
Inclusion Criteria:
- Male or female subject who has completed either study CLON-301 or study CLON-302, or discontinued early for reasons other than adverse events necessitating discontinuation
- Age between 6 and 17 years, inclusive
- Diagnosis of attention deficit hyperactivity disorder of the hyperactive or combined inattentive/hyperactive subtypes according to Diagnostic and Statistical Manual of Mental Disorders IV (DSM IV) criteria
- General good health as judged by the Principal Investigator
- Body mass index (BMI) ≥ 5th percentile of the subject's age group according to the CDC growth chart. BMI is calculated using the formula: weight (kg) / [height (m)]2
- 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 intrauterine device
- 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 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
- Presence of a disorder that would interfere with the absorption, metabolism, or excretion of clonidine
- Presence of alcohol or drug abuse.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm A
Arm Description
CLONICEL (Clonidine HCl sustained release)
Outcomes
Primary Outcome Measures
Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])
Safety assessments were performed at each study visit according to the time and events schedule. All safety analyses were based on safety population
Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])
Safety assessments were performed at each study visit according to the time and events schedule. All safety analysis were based on safety population
Change From Baseline in 12-lead Electrocardiogram in Terms of QT, QTc Fridericia (QTcF), and QTc Bazett's (QTcB) at Week 4
Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12
Change From Baseline in Diastolic Blood Pressure at Week 4
Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement
Change From Baseline in Systolic Blood Pressure at Week 4
Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement
Change From Baseline in Body Temperature at Week 4
Temperature was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement
Change From Baseline in Heart Rate at Week 4
Heart rate was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement
Change From Baseline in 12-lead Electrocardiogram in Terms of Heart Rate at Week 4
Secondary Outcome Measures
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12
The ADHDRS-IV consists of 18 items designed to reflect symptoms of ADHD. Each item is scored on a scale of 0 (Never or rarely) to 3 (Very Often). The subscales of the ADHDRS-IV included the Inattention and the hyperactivity/Impulsivity subscales (total possible score range, 0-54). The Inattention subscale consists of the sum of 9 items: 1, 3, 5, 7, 9, 11, 13, 15, and 17. The Hyperactivity/Impulsivity subscale consists of the sum of 9 items: 2, 4, 6, 8, 10, 12, 14, 16, and 18
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12
CGI-S scale:
1 = Normal, not ill at all; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients
Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12
CGI-I scale:
1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00723190
Brief Title
Open-Label, Chronic Exposure, Safety Study of CLONICEL (Clonidine HCl Sustained Release) in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Official Title
An Open-Label, Chronic Exposure Evaluation of the Safety of CLONICEL (Clonidine HCl Sustained Release) in the Treatment of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shionogi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this 12-month, multi-center, open-label study is to evaluate the safety of CLONICEL (clonidine HCl sustained release) when administered chronically under regular clinical conditions either as monotherapy or in combination with stimulant therapy to children and adolescents with attention deficit hyperactivity disorder (ADHD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
CLONICEL, Attention Deficit Hyperactivity Disorder, clonidine HCl sustained release
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
303 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
CLONICEL (Clonidine HCl sustained release)
Intervention Type
Drug
Intervention Name(s)
CLONICEL (Clonidine HCl sustained release)
Intervention Description
0.1 mg for 1 week; the dose may be escalated to 0.2 mg/day at week 2, 0.3 mg/day at week 3, and 0.4 mg/day at week 4
Primary Outcome Measure Information:
Title
Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])
Description
Safety assessments were performed at each study visit according to the time and events schedule. All safety analyses were based on safety population
Time Frame
1 year
Title
Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])
Description
Safety assessments were performed at each study visit according to the time and events schedule. All safety analysis were based on safety population
Time Frame
1 year
Title
Change From Baseline in 12-lead Electrocardiogram in Terms of QT, QTc Fridericia (QTcF), and QTc Bazett's (QTcB) at Week 4
Time Frame
At baseline and at Week 4
Title
Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12
Time Frame
At baseline and at weeks 1, 2, 3, 4, and months 2, 3, 4, 5, 6, 9, and 12
Title
Change From Baseline in Diastolic Blood Pressure at Week 4
Description
Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement
Time Frame
At baseline and at Week 4
Title
Change From Baseline in Systolic Blood Pressure at Week 4
Description
Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement
Time Frame
At baseline and at Week 4
Title
Change From Baseline in Body Temperature at Week 4
Description
Temperature was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement
Time Frame
At baseline and at Week 4
Title
Change From Baseline in Heart Rate at Week 4
Description
Heart rate was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement
Time Frame
At baseline and at Week 4
Title
Change From Baseline in 12-lead Electrocardiogram in Terms of Heart Rate at Week 4
Time Frame
At baseline and at Week 4
Secondary Outcome Measure Information:
Title
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12
Description
The ADHDRS-IV consists of 18 items designed to reflect symptoms of ADHD. Each item is scored on a scale of 0 (Never or rarely) to 3 (Very Often). The subscales of the ADHDRS-IV included the Inattention and the hyperactivity/Impulsivity subscales (total possible score range, 0-54). The Inattention subscale consists of the sum of 9 items: 1, 3, 5, 7, 9, 11, 13, 15, and 17. The Hyperactivity/Impulsivity subscale consists of the sum of 9 items: 2, 4, 6, 8, 10, 12, 14, 16, and 18
Time Frame
At baseline, months 1, 2, 3, 4, 6, 9, and 12
Title
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12
Description
CGI-S scale:
1 = Normal, not ill at all; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients
Time Frame
At baseline, months 1, 2, 3, 4, 6, 9, and 12
Title
Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12
Description
CGI-I scale:
1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse
Time Frame
At baseline, months 1, 2, 3, 4, 6, 9, and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subject who has completed either study CLON-301 or study CLON-302, or discontinued early for reasons other than adverse events necessitating discontinuation
Age between 6 and 17 years, inclusive
Diagnosis of attention deficit hyperactivity disorder of the hyperactive or combined inattentive/hyperactive subtypes according to Diagnostic and Statistical Manual of Mental Disorders IV (DSM IV) criteria
General good health as judged by the Principal Investigator
Body mass index (BMI) ≥ 5th percentile of the subject's age group according to the CDC growth chart. BMI is calculated using the formula: weight (kg) / [height (m)]2
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 intrauterine device
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 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
Presence of a disorder that would interfere with the absorption, metabolism, or excretion of clonidine
Presence of alcohol or drug abuse.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shionogi Clinical Trials Administrator Clinical Support Help Line
Organizational Affiliation
Shionogi
Official's Role
Study Director
Facility Information:
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
El Centro
State/Province
California
ZIP/Postal Code
92243
Country
United States
City
Irvine
State/Province
California
ZIP/Postal Code
92612
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
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
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
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
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
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
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
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
City
Wharton
State/Province
Texas
ZIP/Postal Code
77488
Country
United States
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open-Label, Chronic Exposure, Safety Study of CLONICEL (Clonidine HCl Sustained Release) in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
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