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

NCT00556959 | Completed Phase 3

• 1 other identifier: CLON-301
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 13

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).

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

ADHD; Clonidine; Attention Deficit; Hyperactivity; CLONICEL; Addrenex

Outcome Measures

Primary Outcomes (1)

• ADHDRS-IV

  Week 5

Secondary Outcomes (2)

• CPRS-L, CGI-S, and CGI-I

  Week 5

• Adverse Events, Laboratory Assessments, Vital Signs, and ECGs

  Throughout Treatment Phase

Study Arms (3)

1

EXPERIMENTAL

CLONICEL High Dose

Drug: high dose clonidine HCl sustained release

2

EXPERIMENTAL

CLONICEL Low Dose

Drug: low dose clonidine HCl sustained release

3

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

high dose clonidine HCl sustained release DRUG

high dose clonidine HCl sustained release tablets for 8 weeks

1

low dose clonidine HCl sustained release DRUG

low dose clonidine HCl sustained release tablets for 8 weeks

2

placebo DRUG

placebo tablets for 8 weeks

3

Eligibility Criteria

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

You may qualify if:

• 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.

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 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.

Sponsors & Collaborators

• Addrenex Pharmaceuticals, Inc.: lead

Study Sites (13)

Unknown Facility

Gainesville, Florida, 32607, United States

Location

Unknown Facility

Jacksonville, Florida, 32216, United States

Location

Unknown Facility

Miami, Florida, 33161, United States

Location

Unknown Facility

Orlando, Florida, 32806, United States

Location

Unknown Facility

Rochester Hills, Michigan, 48307, United States

Location

Unknown Facility

Clementon, New Jersey, 08021, United States

Location

Unknown Facility

Voorhees Township, New Jersey, 08043, United States

Location

Unknown Facility

Chapel Hill, North Carolina, 27514, United States

Location

Unknown Facility

Charlotte, North Carolina, 28209, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, 73103, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, 73116, United States

Location

Unknown Facility

Houston, Texas, 77007, United States

Location

Unknown Facility

Lake Jackson, Texas, 77566, United States

Location

Related Publications (1)

• 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.

  PMID: 21241954 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Spasm

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Moise A Khayrallah, PhD

  Addrenex Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 8, 2007
• First Posted: November 12, 2007
• Study Start: October 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: March 24, 2010

Record last verified: 2008-08

Locations

US (13)