Study to Assess Satisfaction With Modafinil Treatment in Children and Adolescents With ADHD
- Conditions
- ADHD
- Registration Number
- NCT00228540
- Lead Sponsor
- Cephalon
- Brief Summary
An 8-week, Open-Label Study to Characterize the Response to Modafinil (85mg Film-Coated Tablet) Treatment at Dosages up to 425mg/Day in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD) (With an Open-Ended Extension Period)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Patients are included in the study if all of the following criteria are met:
- 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.
Patients are excluded from participating in this study if 1 or more of the following criteria are met:
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (35)
Laszlo J. Mate, MD, PA
🇺🇸West Palm Beach, Florida, United States
Loyola University Medical Center Department of Psychiatry
🇺🇸Maywood, Illinois, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
The Clinical Study Ceneter
🇺🇸Burlington, Vermont, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
ProMed HealthCare
🇺🇸Kalamazoo, Michigan, United States
Pacific Sleep Medicine Service
🇺🇸San Diego, California, United States
Melmed Center
🇺🇸Scottsdale, Arizona, United States
Pharmacology Research Institut
🇺🇸Northridge, California, United States
Clinical Neuroscience Solution
🇺🇸Memphis, Tennessee, United States
Northwest Behavioral Research
🇺🇸Marietta, Georgia, United States
HALP Clinic and ADHD Research
🇺🇸Northbrook, Illinois, United States
Cientifica, Inc.
🇺🇸Wichita, Kansas, United States
Pedia Research, LLC
🇺🇸Owensboro, Kentucky, United States
Michael J. Rieser, MD
🇺🇸Lexington, Kentucky, United States
Regions Hospital
🇺🇸St. Paul, Minnesota, United States
Hunterdon Pediatric Associates
🇺🇸Flemington, New Jersey, United States
OCCI, Inc Salem
🇺🇸Salem, Oregon, United States
UT Medical Group
🇺🇸Memphis, Tennessee, United States
Claghorn-Lesem Research
🇺🇸Bellaire, Texas, United States
Eastside Therapeutic Resource
🇺🇸Kirkland, Washington, United States
Pediatrics and Adolescent
🇺🇸Woodstock, Georgia, United States
UCI Child Development Center
🇺🇸Irvine, California, United States
Dominion Clinical Research
🇺🇸Midlothian, Virginia, United States
Prairie at Saint John's
🇺🇸Fargo, North Dakota, United States
Psycopharmacology Research - LSU Health Science Center
🇺🇸Shreveport, Louisiana, United States
Massachusetts General Hospital
🇺🇸Cambridge, Massachusetts, United States
Odyssey Research
🇺🇸Minot, North Dakota, United States
Bancroft Clinical Research
🇺🇸Cherry Hill, New Jersey, United States
Advanced Pediatrics
🇺🇸Vienna, Virginia, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
Clinical Neurosciences
🇺🇸Orlando, Florida, United States
University of Nebraska
🇺🇸Omaha, Nebraska, United States
Louisiana Research Associates
🇺🇸New Orleans, Louisiana, United States
Medical University of SC
🇺🇸Charleston, South Carolina, United States