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Completed

NCT Number: NCT00723190

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

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).

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CLONICEL (Clonidine HCl sustained release)

Drug

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 outcomes

  1. Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])

    Time frame: 1 year

    Safety assessments were performed at each study visit according to the time and events schedule. All safety analyses were based on safety population

  2. Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])

    Time frame: 1 year

    Safety assessments were performed at each study visit according to the time and events schedule. All safety analysis were based on safety population

  3. 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

  4. 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

  5. Change From Baseline in Diastolic Blood Pressure at Week 4

    Time frame: At baseline and 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

  6. Change From Baseline in Systolic Blood Pressure at Week 4

    Time frame: At baseline and 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

  7. Change From Baseline in Body Temperature at Week 4

    Time frame: At baseline and 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

  8. Change From Baseline in Heart Rate at Week 4

    Time frame: At baseline and 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

  9. Change From Baseline in 12-lead Electrocardiogram in Terms of Heart Rate at Week 4

    Time frame: At baseline and at Week 4

Secondary outcomes

  1. 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

    Time frame: At baseline, 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

  2. Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12

    Time frame: At baseline, 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

  3. Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12

    Time frame: At baseline, 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

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 28, 2008
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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