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| Sponsor: | Cephalon |
|---|---|
| Information provided by: | Cephalon |
| ClinicalTrials.gov Identifier: | NCT00228540 |
Purpose
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Factorial Assignment, Safety/Efficacy Study |
| 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) |
Eligibility| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients are included in the study if all of the following criteria are met:
Exclusion Criteria:
Patients are excluded from participating in this study if 1 or more of the following criteria are met:
Contacts and Locations
Show 39 Study Locations
More Information
| Study ID Numbers: | C1538/3044/AD/US |
| Study First Received: | September 27, 2005 |
| Last Updated: | November 9, 2007 |
| ClinicalTrials.gov Identifier: | NCT00228540 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Attention Deficit Disorder with Hyperactivity Mental Disorders Therapeutic Uses Physiological Effects of Drugs Mental Disorders Diagnosed in Childhood Attention Deficit and Disruptive Behavior Disorders |
Central Nervous System Stimulants Protective Agents Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions Modafinil |