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| Sponsor: | Cephalon |
|---|---|
| Information provided by: | Cephalon |
| ClinicalTrials.gov Identifier: | NCT00343811 |
Purpose
The purpose of this study is to evaluate the continued efficacy of modafinil treatment, compared to placebo treatment, in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) who are responders to modafinil treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder |
Drug: Modafinil |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A 6-Week, Double-Blind, Placebo-Controlled, Parallel Group Randomized Withdrawal Study to Evaluate the Continued Efficacy of Modafinil Treatment in Dosages up to 425mg/Day in Patients With Attention-Deficit/Hyperactivity Disorder Who Are Responders to Modafinil Treatment, Followed by a 12-Month Open-Label Extension Period |
| Estimated Enrollment: | 120 |
| Study Start Date: | June 2006 |
| Study Completion Date: | September 2006 |
The primary objective of the study is to evaluate the continued efficacy of modafinil treatment, compared to placebo treatment, in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) who are responders to modafinil treatment, as assessed by the change from baseline (in this current study) in the total score from the ADHD Rating Scale, Fourth Edition (ADHD-RS-IV) (Home Version) at endpoint (week 6 or last double-blind post-baseline visit).
Eligibility| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must be currently enrolled in a Cephalon-sponsored clinical study and have completed at least 12 months of continuous modafinil treatment. Patients will be included in the study if they continue to meet all applicable criteria in their previous study and 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 23 Study Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00343811 History of Changes |
| Other Study ID Numbers: | C1538/3048/AD/US |
| Study First Received: | June 21, 2006 |
| Last Updated: | June 18, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
Attention-Deficit/Hyper Activity Disorder ADHD |
|
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 |