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Study to Evaluate the Efficacy of Modafinil Treatment in Patients With Attention Deficit Hyperactivity Disorder (ADHD) Who Are Responders to Modafinil Treatment
This study has been completed.
First Received: June 21, 2006   Last Updated: June 18, 2008   History of Changes
Sponsor: Cephalon
Information provided by: Cephalon
ClinicalTrials.gov Identifier: NCT00343811
  Purpose

The purpose of this study is to evaluate the continued efficacy of modafinil treatment, compared to placebo treatment, in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) who are responders to modafinil treatment.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: Modafinil
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A 6-Week, Double-Blind, Placebo-Controlled, Parallel Group Randomized Withdrawal Study to Evaluate the Continued Efficacy of Modafinil Treatment in Dosages up to 425mg/Day in Patients With Attention-Deficit/Hyperactivity Disorder Who Are Responders to Modafinil Treatment, Followed by a 12-Month Open-Label Extension Period

Resource links provided by NLM:


Further study details as provided by Cephalon:

Estimated Enrollment: 120
Study Start Date: June 2006
Study Completion Date: September 2006
Detailed Description:

The primary objective of the study is to evaluate the continued efficacy of modafinil treatment, compared to placebo treatment, in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) who are responders to modafinil treatment, as assessed by the change from baseline (in this current study) in the total score from the ADHD Rating Scale, Fourth Edition (ADHD-RS-IV) (Home Version) at endpoint (week 6 or last double-blind post-baseline visit).

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be currently enrolled in a Cephalon-sponsored clinical study and have completed at least 12 months of continuous modafinil treatment. Patients will be included in the study if they continue to meet all applicable criteria in their previous study and all of the following criteria are met:

    • Written informed consent/assent is obtained.
    • The patient is currently enrolled in study C1538d/312/AD/US or C1538/3044/AD/US and received modafinil treatment, continuously, for at least 12 months.
    • The patient meets the protocol criteria for response at each of the last 2 visits of their previous study. Patients from study C1538d/312/AD/US must have at least a 25% reduction in Attention-Deficit/Hyperactivity Disorder Rating Scale - IV [ADHD-RS-IV] (Home Version) total score compared with the original baseline (this must be the baseline for a previous double-blind, placebo-controlled study of modafinil in ADHD). Patients from study C1538/3044/AD/US must have at least a 25% reduction in total score of the ADHD Index subscale of the Conners' Parent Rating Scale: Revised, Short Form (CPRS:R-S), compared with the baseline value from study C1538/3044/AD/US.
    • The patient is in good health (except for diagnosis of ADHD) as determined by medical and psychiatric history, physical examination, electrocardiograms (ECGs), serum chemistry, hematology, urinalysis, and vital signs.
    • Girls who are post-menarche or sexually active must have a negative urine pregnancy test at the baseline visit, must be using a medically acceptable method of birth control, and must agree to continue use of this method for the duration of the study (and for 30 days after participation in the study). Acceptable methods of birth control include the following: barrier method with spermicide; steroidal contraceptive (eg, oral, transdermal, implanted, or injected) in conjunction with a barrier method; intrauterine device (IUD); and abstinence.
    • The patient has a parent or legal guardian who is willing to participate in the study.

Exclusion Criteria:

  • Patients are excluded from participating in this study if 1 or more of the following criteria are met:

    • The patient has a history or current diagnosis of pervasive developmental disorder, schizophrenia, or other psychotic disorders, or positive clinical assessment of current suicide risk or ideation.
    • The patient has any current psychiatric co-morbidity that requires pharmacotherapy, including but not limited to depression or other mood disorder, anxiety disorder, or pervasive mental disorder.
    • The patient currently uses any other prescription medication, other than modafinil, for ADHD (eg, amphetamine, dextroamphetamine, methylphenidate, pemoline, atomoxetine).
    • Previous exposure to modafinil caused any clinically significant (drug-related) adverse reaction that led to withdrawal from the study, or which the investigator considers likely to put the patient at risk.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00343811

  Hide Study Locations
Locations
United States, Arkansas
Clinical Study Centers, LLC
Little Rock, Arkansas, United States, 72205
United States, California
Encompass Clinical Research
Spring Valley, California, United States, 91978
UCI Child Development Center
Irvine, California, United States, 92612
University of California at San Francisco
San Francisco, California, United States, 94143
United States, Colorado
Alpine Clinical Research
Boulder, Colorado, United States, 80304
United States, Florida
Sarkis Family Psychiatry
Gainesville, Florida, United States, 32607
Miami Research Associates
Miami, Florida, United States, 33173
Amedica Research Institute, Inc.
Hialeah, Florida, United States, 33013
United States, Georgia
Child Neurology Associates
Atlanta, Georgia, United States, 30342
United States, Kentucky
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States, 40004
Michael J. Rieser, MD, PSC
Lexington, Kentucky, United States, 40509
Four Rivers Clinical Research, Inc.
Paducah, Kentucky, United States, 42001
United States, Michigan
Clinical Neurophysiology Services
Troy, Michigan, United States, 48085
United States, Nebraska
University of Nebraska
Omaha, Nebraska, United States, 68198
United States, New Jersey
CNS Research Institute
Clementon, New Jersey, United States, 08021
United States, North Carolina
Triangle Neuropsychiatry
Durham, North Carolina, United States, 27717
Piedmont Neuropsychiatry
Charlotte, North Carolina, United States, 28226
United States, Oklahoma
Pahl Pharmaceutical Research, Inc.
Oklahoma City, Oklahoma, United States, 73118
United States, Oregon
OCCI, Inc.
Salem, Oregon, United States, 97301
United States, Vermont
The Clinical Study Center
Burlington, Vermont, United States, 05401
United States, Virginia
Monarch Research Associates
Norfolk, Virginia, United States, 23510
United States, Washington
Pacific Institute Mental Health
Seattle, Washington, United States, 98133
Eastside Therapeutic Resource
Kirkland, Washington, United States, 98033
Sponsors and Collaborators
Cephalon
  More Information

No publications provided

Study ID Numbers: C1538/3048/AD/US
Study First Received: June 21, 2006
Last Updated: June 18, 2008
ClinicalTrials.gov Identifier: NCT00343811     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Cephalon:
Attention-Deficit/Hyper Activity Disorder
ADHD

Additional relevant MeSH terms:
Disease
Physiological Effects of Drugs
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Central Nervous System Stimulants
Protective Agents
Neuroprotective Agents
Dyskinesias
Pharmacologic Actions
Modafinil
Signs and Symptoms
Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009