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)

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)

Study Overview

• Status: Completed
• Conditions: ADHD
• Intervention / Treatment: Drug: Modafinil

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85254
      • Melmed Center
  • California
    • Irvine, California, United States, 92612
      • UCI Child Development Center
    • Northridge, California, United States, 91324
      • Pharmacology Research Institut
    • San Diego, California, United States, 92121
      • Pacific Sleep Medicine Service
  • Florida
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials
    • Jacksonville, Florida, United States, 32216
      • Clinical Neuroscience Solution
    • Orlando, Florida, United States, 32806
      • Clinical Neurosciences
    • West Palm Beach, Florida, United States, 33407
      • Laszlo J. Mate, MD, PA
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Northwest Behavioral Research
    • Woodstock, Georgia, United States, 30189
      • Pediatrics and Adolescent
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center Department of Psychiatry
    • Northbrook, Illinois, United States, 60062
      • HALP Clinic and ADHD Research
  • Kansas
    • Wichita, Kansas, United States, 67207
      • Cientifica, Inc.
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Michael J. Rieser, MD
    • Owensboro, Kentucky, United States, 42301
      • Pedia Research, LLC
  • Louisiana
    • New Orleans, Louisiana, United States, 70114
      • Louisiana Research Associates
    • Shreveport, Louisiana, United States, 71103
      • Psycopharmacology Research - LSU Health Science Center
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02138
      • Massachusetts General Hospital
  • Michigan
    • Dearborn, Michigan, United States, 48126
      • Odyssey Research
    • Flint, Michigan, United States, 48503
      • Hurley Medical Center
    • Kalamazoo, Michigan, United States, 49008
      • ProMed HealthCare
  • Minnesota
    • St. Paul, Minnesota, United States, 55101
      • Regions Hospital
  • Nebraska
    • McCook, Nebraska, United States, 69001
      • Odyssey Research
    • Omaha, Nebraska, United States, 68198-7630
      • University of Nebraska
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08034
      • Bancroft Clinical Research
    • Flemington, New Jersey, United States, 08822
      • Hunterdon Pediatric Associates
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • Odyssey Research
    • Fargo, North Dakota, United States, 58104
      • Prairie at Saint John's
    • Minot, North Dakota, United States, 58701
      • Odyssey Research
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital
  • Oregon
    • Salem, Oregon, United States, 97301
      • OCCI, Inc Salem
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of SC
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • UT Medical Group
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solution
  • Texas
    • Bellaire, Texas, United States, 77401
      • Claghorn-Lesem Research
  • Vermont
    • Burlington, Vermont, United States, 05401
      • The Clinical Study Ceneter
  • Virginia
    • Midlothian, Virginia, United States, 23112
      • Dominion Clinical Research
    • Vienna, Virginia, United States, 22180
      • Advanced Pediatrics
  • Washington
    • Kirkland, Washington, United States, 98033
      • Eastside Therapeutic Resource

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: Cephalon

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Study Completion (Actual): September 1, 2006

Study Registration Dates

• First Submitted: September 27, 2005
• First Submitted That Met QC Criteria: September 27, 2005
• First Posted (Estimate): September 29, 2005

Study Record Updates

• Last Update Posted (Estimate): May 9, 2014
• Last Update Submitted That Met QC Criteria: May 8, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Central Nervous System Stimulants; Wakefulness-Promoting Agents; Modafinil
• Other Study ID Numbers: C1538/3044/AD/US