Study Evaluating the Safety and Efficacy of CLONICEL® to Treat Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Information source: Addrenex Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Disorder With Hyperactivity
Intervention: high dose clonidine HCl sustained release (Drug); low dose clonidine HCl sustained release (Drug); placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Addrenex Pharmaceuticals, Inc. Official(s) and/or principal investigator(s): Moise A Khayrallah, PhD, Study Director, Affiliation: Addrenex Pharmaceuticals, Inc.
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).
Clinical Details
Official title: A Phase III, Dose-Response Evaluation of the Efficacy and Safety of CLONICEL® (Clonidine HCl Sustained Release) vs. Placebo in the Treatment of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: ADHDRS-IV
Secondary outcome: CPRS-L, CGI-S, and CGI-IAdverse Events, Laboratory Assessments, Vital Signs, and ECGs
Detailed description:
Clonidine is a centrally acting alpha2 adrenergic agonist that has been used effectively
since the early 70s to treat mild to moderate hypertension. In addition to hypertension,
clonidine has been evaluated and used extensively for several other indications, including
attention deficit hyperactivity disorder (ADHD).
An easy to administer clonidine formulation is needed that retains the efficacy of the
current oral formulation but has an improved safety profile. The current trial will
investigate the safety and efficacy of clonidine delivered from the sustained release
formulation of CLONICEL in the treatment of children and adolescents with ADHD.
Eligibility
Minimum age: 6 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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.
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 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.
Locations and Contacts
Gainesville, Florida 32607, United States
Jacksonville, Florida 32216, United States
Miami, Florida 33161, United States
Orlando, Florida 32806, United States
Rochester Hills, Michigan 48307, United States
Clementon, New Jersey 08021, United States
Voorhees, New Jersey 08043, United States
Chapel Hill, North Carolina 27514, United States
Charlotte, North Carolina 28209, United States
Oklahoma City, Oklahoma 73103, United States
Oklahoma City, Oklahoma 73116, United States
Houston, Texas 77007, United States
Lake Jackson, Texas 77566, United States
Additional Information
Starting date: October 2007
Last updated: March 23, 2010
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