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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: | 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) |
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
Hide Study Locations| United States, Alabama | |
| University of Alabama Birmingh | |
| Birmingham, Alabama, United States, 35025 | |
| United States, Arizona | |
| Pivotal Research Center | |
| Mesa, Arizona, United States, 85210 | |
| United States, Arkansas | |
| Clinical Study Centers, LLC | |
| Little Rock, Arkansas, United States, 72205 | |
| River Valley Neurology | |
| Fort Smith, Arkansas, United States, 72901 | |
| United States, California | |
| UCI Child Development Center | |
| Irvine, California, United States, 92612 | |
| BMR HealthQuest | |
| San Diego, California, United States, 92123 | |
| Encompass Clinical Research | |
| Spring Valley, California, United States, 91978 | |
| University of CA San Francisco | |
| San Francisco, California, United States, 94143 | |
| United States, Colorado | |
| Alpine Clinical Research | |
| Boulder, Colorado, United States, 80304 | |
| United States, Florida | |
| Children's Developmental Cente | |
| Maitland, Florida, United States, 32751 | |
| Miami Research Associates | |
| Miami, Florida, United States, 33173 | |
| Amedica Research Inst. | |
| Hialeah, Florida, United States, 33013 | |
| Clinical Neuroscience Solution | |
| West Palm Beach, Florida, United States, 33407 | |
| Sarkis Clinical Trials | |
| Gainesville, Florida, United States, 32607 | |
| United States, Georgia | |
| Child Neurology Assoc. | |
| Atlanta, Georgia, United States, 30342 | |
| Mountainview Center for Resear | |
| Decatur, Georgia, United States, 30033 | |
| United States, Idaho | |
| Foothills Psychiatry | |
| Boise, Idaho, United States, 83702 | |
| United States, Illinois | |
| Consultants in Neurology, Ltd. | |
| Northbrook, Illinois, United States, 60062 | |
| United States, Indiana | |
| Midwest Neurology, Inc. | |
| Danville, Indiana, United States, 46122 | |
| United States, Kansas | |
| Vince and Associates Clinical | |
| Overland Park, Kansas, United States, 66211 | |
| Cientifica at Prarie View | |
| Newton, Kansas, United States, 67114 | |
| United States, Kentucky | |
| Four Rivers Clinical Research | |
| Paducah, Kentucky, United States, 42003 | |
| Kentucky Pediatric/Adult Resea | |
| Bardstown, Kentucky, United States, 40004 | |
| Michael J. Rieser, MD | |
| Lexington, Kentucky, United States, 40509 | |
| Pedia Research, LLC | |
| Owensboro, Kentucky, United States, 42301 | |
| United States, Louisiana | |
| Dolby Providers, Inc. | |
| New Orleans, Louisiana, United States, 70128 | |
| United States, Maryland | |
| NeuroScience, Inc. | |
| Bethesda, Maryland, United States, 20814 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| Clinical Neurophysiology Svcs | |
| Troy, Michigan, United States, 48085 | |
| United States, Nebraska | |
| University of Nebraska | |
| Omaha, Nebraska, United States, 68198-7630 | |
| United States, Nevada | |
| Radiant Research Las Vegas | |
| Las Vegas, Nevada, United States, 89146-5611 | |
| Clinical Research Center of NV | |
| Las Vegas, Nevada, United States, 89014 | |
| United States, New Jersey | |
| Children's Specialized Hospita | |
| Toms River, New Jersey, United States, 08755 | |
| CNS Research Institute | |
| Clementon, New Jersey, United States, 08021 | |
| United States, New York | |
| University of Rochester | |
| Rochester, New York, United States, 14642 | |
| New York Psychiatric Inst | |
| New York, New York, United States, 10032 | |
| University of Buffalo | |
| Buffalo, New York, United States, 14214 | |
| United States, North Carolina | |
| North Carolina Neuropsychiatry | |
| Chapel Hill, North Carolina, United States, 27514 | |
| North Carolina Neuropsychiatry | |
| Charlotte, North Carolina, United States, 28209 | |
| United States, Ohio | |
| Psychiatric Professional Servi | |
| Cincinnati, Ohio, United States, 45267-0559 | |
| United States, Oklahoma | |
| Pahl Pharmaceutical Research | |
| Oklahoma City, Oklahoma, United States, 73118 | |
| United States, Oregon | |
| Summit Research Network Inc. | |
| Portland, Oregon, United States, 97210 | |
| OCCI, Inc. | |
| Salem, Oregon, United States, 97309 | |
| OCCI Eugene | |
| Eugene, Oregon, United States, 97401 | |
| United States, Pennsylvania | |
| Primary Physicians Research | |
| Pittsburgh, Pennsylvania, United States, 15241 | |
| CNS Research Institute PC | |
| Philadelphia, Pennsylvania, United States, 19149 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, Tennessee | |
| Vanderbilt University Medical | |
| Nashville, Tennessee, United States, 37232 | |
| Clinical Neuroscience Solution | |
| Memphis, Tennessee, United States, 38119 | |
| United States, Texas | |
| UT Health Science Center | |
| San Antonio, Texas, United States, 78229-3900 | |
| Dallas Pediatric Neurology | |
| Dallas, Texas, United States, 75230 | |
| United States, Utah | |
| Radiant Research Salt Lake | |
| Salt Lake City, Utah, United States, 84107 | |
| United States, Vermont | |
| Otter Creek Clinical Studies | |
| Burlington, Vermont, United States, 05401 | |
| United States, Virginia | |
| Monarch Research Associates | |
| Norfolk, Virginia, United States, 23510 | |
| United States, Washington | |
| Pacific Institute of Mental He | |
| Seattle, Washington, United States, 98133-9009 | |
| James A. Knutson, MD | |
| Kirkland, Washington, United States, 98033 | |
| United States, Wisconsin | |
| Marshfield Clinical Research | |
| Marshfield, Wisconsin, United States, 54449 | |
More Information
| Study ID Numbers: | C1538D/312/AD/US |
| Study First Received: | September 14, 2005 |
| Last Updated: | January 12, 2006 |
| ClinicalTrials.gov Identifier: | NCT00214981 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
ADHD Attention Deficit/Hyperactivity Disorder |
|
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 |