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

This study has been completed.
Information provided by:
Teva Pharmaceutical Industries Identifier:
First received: September 27, 2005
Last updated: May 8, 2014
Last verified: May 2014
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 Intervention Phase
ADHD Drug: Modafinil Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:

Further study details as provided by Teva Pharmaceutical Industries:

Study Start Date: September 2005
Study Completion Date: September 2006

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).
  Contacts and Locations
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Please refer to this study by its identifier: NCT00228540

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Sponsors and Collaborators
  More Information Identifier: NCT00228540     History of Changes
Other Study ID Numbers: C1538/3044/AD/US
Study First Received: September 27, 2005
Last Updated: May 8, 2014

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on August 23, 2017