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

NCT00723190 | Completed Phase 3 Results

• 1 other identifier: CLON-303
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 27

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).

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

CLONICEL; Attention Deficit Hyperactivity Disorder; clonidine HCl sustained release

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

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

  At baseline and at Week 4

Secondary Outcomes (3)

• 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

  At baseline, months 1, 2, 3, 4, 6, 9, and 12

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

  At baseline, months 1, 2, 3, 4, 6, 9, and 12

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

  At baseline, months 1, 2, 3, 4, 6, 9, and 12

Study Arms (1)

Arm A

EXPERIMENTAL

CLONICEL (Clonidine HCl sustained release)

Drug: CLONICEL (Clonidine HCl sustained release)

Interventions

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

Arm A

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shionogi: lead

Study Sites (27)

Unknown Facility

Little Rock, Arkansas, 72205, United States

Location

Unknown Facility

El Centro, California, 92243, United States

Location

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Irvine, California, 92612, United States

Location

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San Diego, California, 92103, United States

Location

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Bradenton, Florida, 34208, United States

Location

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Gainesville, Florida, 32607, United States

Location

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Jacksonville, Florida, 32216, United States

Location

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Lauderhill, Florida, 33319, United States

Location

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Miami, Florida, 33161, United States

Location

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Orlando, Florida, 32806, United States

Location

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Bardstown, Kentucky, 40004, United States

Location

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Baltimore, Maryland, 21208, United States

Location

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Rochester Hills, Michigan, 48307, United States

Location

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St Louis, Missouri, 63005, United States

Location

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Voorhees Township, New Jersey, 08043, United States

Location

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Willingboro, New Jersey, 08046, United States

Location

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Chapel Hill, North Carolina, 27514, United States

Location

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Charlotte, North Carolina, 28209, United States

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Durham, North Carolina, 27705, United States

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Cleveland, Ohio, 44106, United States

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Oklahoma City, Oklahoma, 73103, United States

Location

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Oklahoma City, Oklahoma, 73116, United States

Location

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Houston, Texas, 77007, United States

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Lake Jackson, Texas, 77566, United States

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Wharton, Texas, 77488, United States

Location

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Clinton, Utah, 84015, United States

Location

Unknown Facility

Kirkland, Washington, 98033, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

Efficacy results need to be reviewed in the context that the study is an open-label/non-placebo controlled study. No formal statistical testing of efficacy results has been done. No adjustments have been made to account for drop-outs or missing data.

Results Point of Contact

• Title: Shionogi Clinical Trials Administrator
• Organization: Shionogi USA

shionogiclintrialsadmin@shionogi.com

800-849-9707

Study Officials

• Shionogi Clinical Trials Administrator Clinical Support Help Line

  Shionogi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 24, 2008
• First Posted: July 28, 2008
• Study Start: January 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: June 1, 2010
• Last Updated: April 18, 2018
• Results First Posted: February 27, 2012

Record last verified: 2018-04

Locations

US (27)