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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00228540
Recruitment Status : Completed
First Posted : September 29, 2005
Last Update Posted : May 9, 2014
Information provided by:
Teva Pharmaceutical Industries

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)

Condition or disease Intervention/treatment Phase
ADHD Drug: Modafinil Phase 3

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2005
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Modafinil

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00228540

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Sponsors and Collaborators

Layout table for additonal information Identifier: NCT00228540    
Other Study ID Numbers: C1538/3044/AD/US
First Posted: September 29, 2005    Key Record Dates
Last Update Posted: May 9, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action