Study to Assess Satisfaction With Modafinil Treatment in Children and Adolescents With ADHD

Condition(s) targeted: ADHD

Intervention: Modafinil (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Cephalon

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)

Official title: 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)

Study design: Treatment, Non-Randomized, Open Label, Dose Comparison, Factorial Assignment, Safety/Efficacy Study

Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 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. Exclusion Criteria: 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).

Melmed Center, Scottsdale, Arizona 85254, United States

Pacific Sleep Medicine Service, San Diego, California 92121, United States

UCI Child Development Center, Irvine, California 92612, United States

Pharmacology Research Institut, Northridge, California 91324, United States

Sarkis Clinical Trials, Gainesville, Florida 32607, United States

Clinical Neuroscience Solution, Jacksonville, Florida 32216, United States

Laszlo J. Mate, MD, PA, West Palm Beach, Florida 33407, United States

Clinical Neurosciences, Orlando, Florida 32806, United States

Pediatrics and Adolescent, Woodstock, Georgia 30189, United States

Northwest Behavioral Research, Marietta, Georgia 30060, 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

Hurley Medical Center, Flint, Michigan 48503, United States

ProMed HealthCare, Kalamazoo, Michigan 49008, United States

Odyssey Research, Dearborn, Michigan 48126, United States

Regions Hospital, St. Paul, Minnesota 55101, United States

University of Nebraska, Omaha, Nebraska 68198-7630, United States

Odyssey Research, McCook, Nebraska 69001, 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

Odyssey Research, Minot, North Dakota 58701, United States

Prairie at Saint John's, Fargo, North Dakota 58104, 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

Clinical Neuroscience Solution, Memphis, Tennessee 38119, United States

UT Medical Group, Memphis, Tennessee 38105, 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

Starting date: September 2005
Ending date: September 2006
Last updated: November 9, 2007