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Sponsored by: |
Cephalon |
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Information provided by: | Cephalon |
ClinicalTrials.gov Identifier: | NCT00315276 |
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]).
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | C1538/2027/AD/US |
Study First Received: | April 17, 2006 |
Last Updated: | November 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00315276 |
Health Authority: | United States: Food and Drug Administration |
ADHD |
Signs and Symptoms Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood Neurologic Manifestations |
Attention Deficit and Disruptive Behavior Disorders Hyperkinesis Dyskinesias Modafinil |
Pathologic Processes Disease Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases |
Central Nervous System Stimulants Protective Agents Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions |