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| Sponsor: | Cephalon |
|---|---|
| Information provided by: | Cephalon |
| ClinicalTrials.gov Identifier: | NCT00315276 |
Purpose
The purpose of the study is to evaluate the efficacy and safety of modafinil administered once daily for 9 weeks at doses of 255, 340, 425, and 510 mg as treatment for adults with ADHD.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder ADHD |
Drug: Modafinil |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A 9-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study to Evaluate the Efficacy and Safety of Modafinil as Treatment for Adults With Attention Deficit/Hyperactivity Disorder |
| Estimated Enrollment: | 370 |
| Study Start Date: | May 2006 |
| Study Completion Date: | January 2007 |
The primary objective of the study is to determine whether modafinil at 255, 340, 425, or 510 mg'day is more effective than a placebo in alleviating the symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults as determined by the change from baseline in the total score from the investigator-completed Adult ADHD Investigator Symptoms Rating Scale (AISRS) the at endpoint (last post-baseline observation [week 9 or early termination]).
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arkansas | |
| Neurology Clinical Study Centers, LLC | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Bay Area Research Institute | |
| Lafayette, California, United States, 94549 | |
| Pharmacology Research Institute | |
| Northridge, California, United States, 91324 | |
| UCSD Medical Center | |
| San Diego, California, United States, 92103 | |
| Peninsula Research Associates | |
| Rolling Hills Estates, California, United States, 90274 | |
| United States, Florida | |
| Clinical Neuroscience Solution, Inc. | |
| Orlando, Florida, United States, 32806 | |
| United States, Illinois | |
| University of Illinois | |
| Chicago, Illinois, United States, 60608 | |
| United States, Kentucky | |
| Michael J. Reiser, MD, LLC | |
| Lexington, Kentucky, United States, 40509 | |
| United States, Maryland | |
| Adult ADD Center of Maryland | |
| Lutherville, Maryland, United States, 21093 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Cambridge, Massachusetts, United States, 02138 | |
| United States, Michigan | |
| Rochester Center for Behavioral Medicine | |
| Rochester, Michigan, United States, 48307 | |
| United States, New Jersey | |
| CRI WorldWide, LLC | |
| Clementon, New Jersey, United States, 08021 | |
| United States, New York | |
| New York University | |
| New York, New York, United States, 10010 | |
| United States, Oregon | |
| Summit Research Network Inc. | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| CRI WorldWide, LLC | |
| Philadelphia, Pennsylvania, United States, 19149 | |
| United States, South Carolina | |
| South East Health Consultants, LLC | |
| Charleston, South Carolina, United States, 29407 | |
| United States, Tennessee | |
| Clinical Neuroscience Solution | |
| Memphis, Tennessee, United States, 38119 | |
| United States, Vermont | |
| Neuropsychiatric Associates | |
| Woodstock, Vermont, United States, 05091 | |
More Information
| Study ID Numbers: | C1538/2027/AD/US |
| Study First Received: | April 17, 2006 |
| Last Updated: | November 9, 2007 |
| ClinicalTrials.gov Identifier: | NCT00315276 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
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 |