Evaluate the Safety and Efficacy of Modafinil in Children and Adolescents With ADHD
NCT ID: NCT00214981
Last Updated: 2012-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
2003-09-30
2006-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Modafinil
Eligibility Criteria
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Inclusion Criteria
* weight and height between the 5th and 95th percentile on the National Center for Health Statistics (NCHS) growth chart for age, height, and weight
* if more than 6 months since last dose of study drug, meets the full DSM-IV crieria for ADHD (combined typd, predominantly inattentive type, or predominantly hyperactive - impulsive type) at screening, as manifested by a psychiatric/clinical evaluation and confirmed by a structured diagnostic interview, namely, the Diagnostic Interview Schedule for Children, Fourth Edition (DISC-IV).
* are in good health (except for a diagnosis of ADHD) as determined by medical and psychiatric history, physical examination, ECG, serum chemistry, hematology, urinalysis
* girls of child bearing potential (Tanner scale \>3) OR all girls 8 years of age and older have a negative urine pregnancy test at screening, 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). (NOTE: For conducting pregnancy tests, the investigator has the option of determining the sexual maturity all girls 8 years of age and older.) Acceptable methods of birth control include: barrier method with spermicide; steroidal contraceptive (eg, oral, transdermal, implanted, and injected) in conjunction with a barrier method; intrauterine device (IUD); or abstinence
* have a parent or legal guardian who is willing to participate in the study.
Exclusion Criteria
* any current psychiatric comorbidity, including but not limited to depression or other mood disorder, anxiety disorder, or pervasive mental disorder, that requires pharmacotherapy
* a clinically significant drug sensitivity to stimulants such as amphetamine, dextroamphetamine, methylphenidate, pemoline
* failure to respond to 2 or more adequate courses (dose or duration) of ADHD therapy
* use of any other prescription medications for ADHD (e.g., amphetamine, dextroamphetamine, methylphenidate, pemoline, atomoxetine) after the screening visit
* use of any MAO inhibitors or SSRIs within 2 weeks of the baseline visit
* hypertension, defined as follows (SBP = systolic blood pressure and DBP = diastolic blood pressure):
* ages 6-9 years SBP \> 122mmHg or DBP\>78mmHg
* ages 10-12 years SBP \> 126mmHg or DBP\>82mmHg
* ages 13-17 years SBP \> 136mmHg or DBP\>86mmHg
* hypotension, defined as sitting systolic blood pressure (taken after resting for 5 minutes) of less than 50mmHg for children under 12 years of age or less than 80mmHg for children 12 and older
* a sitting pulse outside the range of 60 through 115 bpm after resting for 5 minutes
6 Years
17 Years
ALL
No
Sponsors
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Cephalon
INDUSTRY
Responsible Party
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Locations
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University of Alabama Birmingh
Birmingham, Alabama, United States
Pivotal Research Center
Mesa, Arizona, United States
River Valley Neurology
Fort Smith, Arkansas, United States
Clinical Study Centers, LLC
Little Rock, Arkansas, United States
UCI Child Development Center
Irvine, California, United States
BMR HealthQuest
San Diego, California, United States
University of CA San Francisco
San Francisco, California, United States
Encompass Clinical Research
Spring Valley, California, United States
Alpine Clinical Research
Boulder, Colorado, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Amedica Research Inst.
Hialeah, Florida, United States
Children's Developmental Cente
Maitland, Florida, United States
Miami Research Associates
Miami, Florida, United States
Clinical Neuroscience Solution
West Palm Beach, Florida, United States
Child Neurology Assoc.
Atlanta, Georgia, United States
Mountainview Center for Resear
Decatur, Georgia, United States
Foothills Psychiatry
Boise, Idaho, United States
Consultants in Neurology, Ltd.
Northbrook, Illinois, United States
Midwest Neurology, Inc.
Danville, Indiana, United States
Cientifica at Prarie View
Newton, Kansas, United States
Vince and Associates Clinical
Overland Park, Kansas, United States
Kentucky Pediatric/Adult Resea
Bardstown, Kentucky, United States
Michael J. Rieser, MD
Lexington, Kentucky, United States
Pedia Research, LLC
Owensboro, Kentucky, United States
Four Rivers Clinical Research
Paducah, Kentucky, United States
Dolby Providers, Inc.
New Orleans, Louisiana, United States
NeuroScience, Inc.
Bethesda, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Clinical Neurophysiology Svcs
Troy, Michigan, United States
University of Nebraska
Omaha, Nebraska, United States
Clinical Research Center of NV
Las Vegas, Nevada, United States
Radiant Research Las Vegas
Las Vegas, Nevada, United States
CNS Research Institute
Clementon, New Jersey, United States
Children's Specialized Hospita
Toms River, New Jersey, United States
University of Buffalo
Buffalo, New York, United States
New York Psychiatric Inst
New York, New York, United States
University of Rochester
Rochester, New York, United States
North Carolina Neuropsychiatry
Chapel Hill, North Carolina, United States
North Carolina Neuropsychiatry
Charlotte, North Carolina, United States
Psychiatric Professional Servi
Cincinnati, Ohio, United States
Pahl Pharmaceutical Research
Oklahoma City, Oklahoma, United States
OCCI Eugene
Eugene, Oregon, United States
Summit Research Network Inc.
Portland, Oregon, United States
OCCI, Inc.
Salem, Oregon, United States
CNS Research Institute PC
Philadelphia, Pennsylvania, United States
Primary Physicians Research
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Clinical Neuroscience Solution
Memphis, Tennessee, United States
Vanderbilt University Medical
Nashville, Tennessee, United States
Dallas Pediatric Neurology
Dallas, Texas, United States
UT Health Science Center
San Antonio, Texas, United States
Radiant Research Salt Lake
Salt Lake City, Utah, United States
Otter Creek Clinical Studies
Burlington, Vermont, United States
Monarch Research Associates
Norfolk, Virginia, United States
James A. Knutson, MD
Kirkland, Washington, United States
Pacific Institute of Mental He
Seattle, Washington, United States
Marshfield Clinical Research
Marshfield, Wisconsin, United States
Countries
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Other Identifiers
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C1538D/312/AD/US
Identifier Type: -
Identifier Source: org_study_id