Clinical trial NCT00228540: Study to Assess Satisfaction With Modafinil Treatment in Children and Adolescents With ADHD
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ADHD
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-29
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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)


Eligibility 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).

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