Study to Assess Satisfaction With Modafinil Treatment in Children and Adolescents With ADHD
NCT ID: NCT00228540
Last Updated: 2014-05-09
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
2005-09-30
2006-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
TREATMENT
NONE
Interventions
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Modafinil
Eligibility Criteria
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Inclusion Criteria
* Written informed consent/assent is obtained.
* The patient is a boy or girl 6 through 17 years of age (inclusive) at the screening visit, and both the patient and parent/legal guardian are English-speaking.
* The patient has a previous diagnosis of ADHD and is currently receiving medication for the treatment of ADHD.
* The patient, or the patient's parent/legal guardian, is dissatified (VAS score \<50) with current ADHD medication (medication and reason for dissatisfaction documented).
* The patient is in good health as determined by a medical or psychiatric history, screening physical examination, and clinical laboratory evaluations.
* Girls who are postmenarche or sexually active, must have a negative urine pregnancy test prior to 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, implant, or injected) in conjunction with a barrier method; intrauterine device (IUD); and abstinence.
* The patient's parent/legal guardian must be willing and able to comply with study procedures and restrictions.
Exclusion Criteria
* The patient has any current psychiatric comorbidity, including but not limited to depression or other mood disorder, or pervasive mental disorder, that requires pharmacotherapy.
* The patient is satisfied with current ADHD medication and has no side effects.
* The patient is using other prescription medications for ADHD with psychoactive properties (eg, amphetamine, dextroamphetamine, methylphenidate, pemoline, atomoxetine) after the baseline visit.
* The patient has used monoamine oxidase (MAO) inhibitors within 1 week before the baseline visit.
* The patient has used an investigational drug within 1 month before the screening visit.
* The patient has a known clinically significant drug sensitivity to modafinil or any of its inactive ingredients.
* The patient is pregnant or lactating. (Any patients becoming pregnant during the study will be withdrawn from study).
6 Years
17 Years
ALL
No
Sponsors
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Cephalon
INDUSTRY
Locations
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Melmed Center
Scottsdale, Arizona, United States
UCI Child Development Center
Irvine, California, United States
Pharmacology Research Institut
Northridge, California, United States
Pacific Sleep Medicine Service
San Diego, California, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Clinical Neuroscience Solution
Jacksonville, Florida, United States
Clinical Neurosciences
Orlando, Florida, United States
Laszlo J. Mate, MD, PA
West Palm Beach, Florida, United States
Northwest Behavioral Research
Marietta, Georgia, United States
Pediatrics and Adolescent
Woodstock, Georgia, United States
Loyola University Medical Center Department of Psychiatry
Maywood, Illinois, United States
HALP Clinic and ADHD Research
Northbrook, Illinois, United States
Cientifica, Inc.
Wichita, Kansas, United States
Michael J. Rieser, MD
Lexington, Kentucky, United States
Pedia Research, LLC
Owensboro, Kentucky, United States
Louisiana Research Associates
New Orleans, Louisiana, United States
Psycopharmacology Research - LSU Health Science Center
Shreveport, Louisiana, United States
Massachusetts General Hospital
Cambridge, Massachusetts, United States
Odyssey Research
Dearborn, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
ProMed HealthCare
Kalamazoo, Michigan, United States
Regions Hospital
Saint Paul, Minnesota, United States
Odyssey Research
McCook, Nebraska, United States
University of Nebraska
Omaha, Nebraska, United States
Bancroft Clinical Research
Cherry Hill, New Jersey, United States
Hunterdon Pediatric Associates
Flemington, New Jersey, United States
Odyssey Research
Bismarck, North Dakota, United States
Prairie at Saint John's
Fargo, North Dakota, United States
Odyssey Research
Minot, North Dakota, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
OCCI, Inc Salem
Salem, Oregon, United States
Medical University of SC
Charleston, South Carolina, United States
UT Medical Group
Memphis, Tennessee, United States
Clinical Neuroscience Solution
Memphis, Tennessee, United States
Claghorn-Lesem Research
Bellaire, Texas, United States
The Clinical Study Ceneter
Burlington, Vermont, United States
Dominion Clinical Research
Midlothian, Virginia, United States
Advanced Pediatrics
Vienna, Virginia, United States
Eastside Therapeutic Resource
Kirkland, Washington, United States
Countries
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Other Identifiers
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C1538/3044/AD/US
Identifier Type: -
Identifier Source: org_study_id
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