Study to Assess Satisfaction With Modafinil Treatment in Children and Adolescents With ADHD
An 8 Week, Open-Label Study to Characterize the Response to Modafinil (85 mg Film Coated Tablet) Treatment at Dosages Up to 425 mg/Day in Children and Adolescents With Attention Deficit/Hyperactivity Disorder (ADHD) (With an Open Ended Extension Period)
1 other identifier
interventional
N/A
1 country
39
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2005
Shorter than P25 for phase_3
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 27, 2005
CompletedFirst Posted
Study publicly available on registry
September 29, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedMay 9, 2014
May 1, 2014
September 27, 2005
May 8, 2014
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cephalonlead
Study Sites (39)
Melmed Center
Scottsdale, Arizona, 85254, United States
UCI Child Development Center
Irvine, California, 92612, United States
Pharmacology Research Institut
Northridge, California, 91324, United States
Pacific Sleep Medicine Service
San Diego, California, 92121, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
Clinical Neuroscience Solution
Jacksonville, Florida, 32216, United States
Clinical Neurosciences
Orlando, Florida, 32806, United States
Laszlo J. Mate, MD, PA
West Palm Beach, Florida, 33407, United States
Northwest Behavioral Research
Marietta, Georgia, 30060, United States
Pediatrics and Adolescent
Woodstock, Georgia, 30189, United States
Loyola University Medical Center Department of Psychiatry
Maywood, Illinois, 60153, United States
HALP Clinic and ADHD Research
Northbrook, Illinois, 60062, United States
Cientifica, Inc.
Wichita, Kansas, 67207, United States
Michael J. Rieser, MD
Lexington, Kentucky, 40509, United States
Pedia Research, LLC
Owensboro, Kentucky, 42301, United States
Louisiana Research Associates
New Orleans, Louisiana, 70114, United States
Psycopharmacology Research - LSU Health Science Center
Shreveport, Louisiana, 71103, United States
Massachusetts General Hospital
Cambridge, Massachusetts, 02138, United States
Odyssey Research
Dearborn, Michigan, 48126, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
ProMed HealthCare
Kalamazoo, Michigan, 49008, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
Odyssey Research
McCook, Nebraska, 69001, United States
University of Nebraska
Omaha, Nebraska, 68198-7630, United States
Bancroft Clinical Research
Cherry Hill, New Jersey, 08034, United States
Hunterdon Pediatric Associates
Flemington, New Jersey, 08822, United States
Odyssey Research
Bismarck, North Dakota, 58501, United States
Prairie at Saint John's
Fargo, North Dakota, 58104, United States
Odyssey Research
Minot, North Dakota, 58701, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
OCCI, Inc Salem
Salem, Oregon, 97301, United States
Medical University of SC
Charleston, South Carolina, 29425, United States
UT Medical Group
Memphis, Tennessee, 38105, United States
Clinical Neuroscience Solution
Memphis, Tennessee, 38119, United States
Claghorn-Lesem Research
Bellaire, Texas, 77401, United States
The Clinical Study Ceneter
Burlington, Vermont, 05401, United States
Dominion Clinical Research
Midlothian, Virginia, 23112, United States
Advanced Pediatrics
Vienna, Virginia, 22180, United States
Eastside Therapeutic Resource
Kirkland, Washington, 98033, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 27, 2005
First Posted
September 29, 2005
Study Start
September 1, 2005
Study Completion
September 1, 2006
Last Updated
May 9, 2014
Record last verified: 2014-05