Study Evaluating the Safety and Efficacy of CLONICEL® to Treat Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
This study has been completed.
Sponsor:
Addrenex Pharmaceuticals, Inc.
Information provided by:
Addrenex Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00556959
First received: November 8, 2007
Last updated: March 23, 2010
Last verified: August 2008
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Disorder With Hyperactivity |
Drug: high dose clonidine HCl sustained release Drug: low dose clonidine HCl sustained release Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by Addrenex Pharmaceuticals, Inc.:
Primary Outcome Measures:
- ADHDRS-IV [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- CPRS-L, CGI-S, and CGI-I [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
- Adverse Events, Laboratory Assessments, Vital Signs, and ECGs [ Time Frame: Throughout Treatment Phase ] [ Designated as safety issue: Yes ]
| Enrollment: | 236 |
| Study Start Date: | October 2007 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
CLONICEL High Dose
|
Drug: high dose clonidine HCl sustained release
high dose clonidine HCl sustained release tablets for 8 weeks
|
|
Experimental: 2
CLONICEL Low Dose
|
Drug: low dose clonidine HCl sustained release
low dose clonidine HCl sustained release tablets for 8 weeks
|
|
Placebo Comparator: 3
Placebo
|
Drug: placebo
placebo tablets for 8 weeks
|
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| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00556959
Locations
| United States, Florida | |
| Gainesville, Florida, United States, 32607 | |
| Jacksonville, Florida, United States, 32216 | |
| Miami, Florida, United States, 33161 | |
| Orlando, Florida, United States, 32806 | |
| United States, Michigan | |
| Rochester Hills, Michigan, United States, 48307 | |
| United States, New Jersey | |
| Clementon, New Jersey, United States, 08021 | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, North Carolina | |
| Chapel Hill, North Carolina, United States, 27514 | |
| Charlotte, North Carolina, United States, 28209 | |
| United States, Oklahoma | |
| Oklahoma City, Oklahoma, United States, 73116 | |
| Oklahoma City, Oklahoma, United States, 73103 | |
| United States, Texas | |
| Houston, Texas, United States, 77007 | |
| Lake Jackson, Texas, United States, 77566 | |
Sponsors and Collaborators
Addrenex Pharmaceuticals, Inc.
Investigators
| Study Director: | Moise A Khayrallah, PhD | Addrenex Pharmaceuticals, Inc. |
More Information
No publications provided by Addrenex Pharmaceuticals, Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Moise Khayrallah, PhD / President & CEO, Addrenex Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00556959 History of Changes |
| Other Study ID Numbers: | CLON-301 |
| Study First Received: | November 8, 2007 |
| Last Updated: | March 23, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Addrenex Pharmaceuticals, Inc.:
|
ADHD Clonidine Attention Deficit |
Hyperactivity CLONICEL Addrenex |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Clonidine Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
Sympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 21, 2013