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| Sponsor: | Cephalon |
|---|---|
| Information provided by: | Cephalon |
| ClinicalTrials.gov Identifier: | NCT00214981 |
Purpose
Primary objective of this study is to evaluate the safety of treatment with modafinil film-coated tablet.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit/Hyperactivity Disorder ADHD |
Drug: Modafinil |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
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 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:
Contacts and Locations
Show 57 Study Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00214981 History of Changes |
| Other Study ID Numbers: | C1538D/312/AD/US |
| Study First Received: | September 14, 2005 |
| Last Updated: | January 12, 2006 |
| Health Authority: | United States: Food and Drug Administration |
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ADHD Attention Deficit/Hyperactivity Disorder |
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
Modafinil Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Neuroprotective Agents Protective Agents |