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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: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| 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
Hide Study Locations| United States, Arkansas | |
| Clinical Study Centers, LLC | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Encompass Clinical Research | |
| Spring Valley, California, United States, 91978 | |
| UCI Child Development Center | |
| Irvine, California, United States, 92612 | |
| University of California at San Francisco | |
| San Francisco, California, United States, 94143 | |
| United States, Colorado | |
| Alpine Clinical Research | |
| Boulder, Colorado, United States, 80304 | |
| United States, Florida | |
| Sarkis Family Psychiatry | |
| Gainesville, Florida, United States, 32607 | |
| Miami Research Associates | |
| Miami, Florida, United States, 33173 | |
| Amedica Research Institute, Inc. | |
| Hialeah, Florida, United States, 33013 | |
| United States, Georgia | |
| Child Neurology Associates | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Kentucky | |
| Kentucky Pediatric/Adult Research | |
| Bardstown, Kentucky, United States, 40004 | |
| Michael J. Rieser, MD, PSC | |
| Lexington, Kentucky, United States, 40509 | |
| Four Rivers Clinical Research, Inc. | |
| Paducah, Kentucky, United States, 42001 | |
| United States, Michigan | |
| Clinical Neurophysiology Services | |
| Troy, Michigan, United States, 48085 | |
| United States, Nebraska | |
| University of Nebraska | |
| Omaha, Nebraska, United States, 68198 | |
| United States, New Jersey | |
| CNS Research Institute | |
| Clementon, New Jersey, United States, 08021 | |
| United States, North Carolina | |
| Triangle Neuropsychiatry | |
| Durham, North Carolina, United States, 27717 | |
| Piedmont Neuropsychiatry | |
| Charlotte, North Carolina, United States, 28226 | |
| United States, Oklahoma | |
| Pahl Pharmaceutical Research, Inc. | |
| Oklahoma City, Oklahoma, United States, 73118 | |
| United States, Oregon | |
| OCCI, Inc. | |
| Salem, Oregon, United States, 97301 | |
| United States, Vermont | |
| The Clinical Study Center | |
| Burlington, Vermont, United States, 05401 | |
| United States, Virginia | |
| Monarch Research Associates | |
| Norfolk, Virginia, United States, 23510 | |
| United States, Washington | |
| Pacific Institute Mental Health | |
| Seattle, Washington, United States, 98133 | |
| Eastside Therapeutic Resource | |
| Kirkland, Washington, United States, 98033 | |
More Information
| Study ID Numbers: | C1538/3048/AD/US |
| Study First Received: | June 21, 2006 |
| Last Updated: | June 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00343811 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Attention-Deficit/Hyper Activity Disorder ADHD |
|
Disease Physiological Effects of Drugs Nervous System Diseases Attention Deficit and Disruptive Behavior Disorders Central Nervous System Stimulants Protective Agents Neuroprotective Agents Dyskinesias Pharmacologic Actions Modafinil |
Signs and Symptoms Pathologic Processes Attention Deficit Disorder with Hyperactivity Mental Disorders Therapeutic Uses Mental Disorders Diagnosed in Childhood Hyperkinesis Neurologic Manifestations Central Nervous System Agents |