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

ADHD Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00228540
• Other study ID #: C1538/3044/AD/US
• Status: Completed
• Phase: Phase 3
• First received: September 27, 2005
• Last updated: May 8, 2014
• Start date: September 2005
• Est. completion date: September 2006

Study information

• Verified date: May 2014
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Drug:
• Modafinil

Locations

Country	Name	City	State
United States	Claghorn-Lesem Research	Bellaire	Texas
United States	Odyssey Research	Bismarck	North Dakota
United States	The Clinical Study Ceneter	Burlington	Vermont
United States	Massachusetts General Hospital	Cambridge	Massachusetts
United States	Medical University of SC	Charleston	South Carolina
United States	Bancroft Clinical Research	Cherry Hill	New Jersey
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	Odyssey Research	Dearborn	Michigan
United States	Prairie at Saint John's	Fargo	North Dakota
United States	Hunterdon Pediatric Associates	Flemington	New Jersey
United States	Hurley Medical Center	Flint	Michigan
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	UCI Child Development Center	Irvine	California
United States	Clinical Neuroscience Solution	Jacksonville	Florida
United States	ProMed HealthCare	Kalamazoo	Michigan
United States	Eastside Therapeutic Resource	Kirkland	Washington
United States	Michael J. Rieser, MD	Lexington	Kentucky
United States	Northwest Behavioral Research	Marietta	Georgia
United States	Loyola University Medical Center Department of Psychiatry	Maywood	Illinois
United States	Odyssey Research	McCook	Nebraska
United States	Clinical Neuroscience Solution	Memphis	Tennessee
United States	UT Medical Group	Memphis	Tennessee
United States	Dominion Clinical Research	Midlothian	Virginia
United States	Odyssey Research	Minot	North Dakota
United States	Louisiana Research Associates	New Orleans	Louisiana
United States	HALP Clinic and ADHD Research	Northbrook	Illinois
United States	Pharmacology Research Institut	Northridge	California
United States	University of Nebraska	Omaha	Nebraska
United States	Clinical Neurosciences	Orlando	Florida
United States	Pedia Research, LLC	Owensboro	Kentucky
United States	OCCI, Inc Salem	Salem	Oregon
United States	Pacific Sleep Medicine Service	San Diego	California
United States	Melmed Center	Scottsdale	Arizona
United States	Psycopharmacology Research - LSU Health Science Center	Shreveport	Louisiana
United States	Regions Hospital	St. Paul	Minnesota
United States	Advanced Pediatrics	Vienna	Virginia
United States	Laszlo J. Mate, MD, PA	West Palm Beach	Florida
United States	Cientifica, Inc.	Wichita	Kansas
United States	Pediatrics and Adolescent	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Country where clinical trial is conducted

United States,