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Sponsored by: |
Cephalon |
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Information provided by: | Cephalon |
ClinicalTrials.gov Identifier: | NCT00214981 |
Primary objective of this study is to evaluate the safety of treatment with modafinil film-coated tablet.
Condition | Intervention | Phase |
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Attention Deficit/Hyperactivity Disorder ADHD |
Drug: Modafinil |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study |
Official Title: | A 1-Year, Open-Label, Flexible-Dosage Study to Evaluate the Safety and Continued Efficacy of Modafinil (Film-Coated Tablet Formulation) in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (Followed by an Open-Ended Extension Period) |
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 they participated in a previous qualifying study with modafinil and, in the opinion of the investigator, will continue to benefit from treatment with modafinil. In addition, the following criteria must be met:
Exclusion Criteria: Patients are excluded from participating in this study if 1 or more of the following criteria are met:
Study ID Numbers: | C1538D/312/AD/US |
Study First Received: | September 14, 2005 |
Last Updated: | January 12, 2006 |
ClinicalTrials.gov Identifier: | NCT00214981 |
Health Authority: | United States: Food and Drug Administration |
ADHD Attention Deficit/Hyperactivity Disorder |
Signs and Symptoms Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood Neurologic Manifestations |
Attention Deficit and Disruptive Behavior Disorders Hyperkinesis Dyskinesias Modafinil |
Pathologic Processes Disease Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases |
Central Nervous System Stimulants Protective Agents Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions |