Open-Label, Chronic Exposure, Safety Study of CLONICEL (Clonidine HCl Sustained Release) in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)

Attention Deficit Hyperactivity Disorder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723190
• Other study ID #: CLON-303
• Status: Completed
• Phase: Phase 3
• First received: July 24, 2008
• Last updated: April 16, 2018
• Start date: January 2008
• Est. completion date: June 2010

Study information

• Verified date: April 2018
• Source: Shionogi Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: June 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Disease
• Hyperkinesis

Intervention

Drug:
• CLONICEL (Clonidine HCl sustained release)
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shionogi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Primary	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	1 year
Primary	Change From Baseline in 12-lead Electrocardiogram in Terms of QT, QTc Fridericia (QTcF), and QTc Bazett's (QTcB) at Week 4		At baseline and at Week 4
Primary	Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12		At baseline and at weeks 1, 2, 3, 4, and months 2, 3, 4, 5, 6, 9, and 12
Primary	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	At baseline and at Week 4
Primary	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	At baseline and at Week 4
Primary	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	At baseline and at Week 4
Primary	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	At baseline and at Week 4
Primary	Change From Baseline in 12-lead Electrocardiogram in Terms of Heart Rate at Week 4		At baseline and at Week 4
Secondary	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	At baseline, months 1, 2, 3, 4, 6, 9, and 12
Secondary	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	At baseline, months 1, 2, 3, 4, 6, 9, and 12
Secondary	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	At baseline, months 1, 2, 3, 4, 6, 9, and 12