Study to Evaluate the Efficacy of Modafinil Treatment in Patients With Attention Deficit Hyperactivity Disorder (ADHD) Who Are Responders to Modafinil Treatment
- Conditions
- Attention Deficit Hyperactivity Disorder
- Registration Number
- NCT00343811
- Lead Sponsor
- Cephalon
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
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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:
- Written informed consent/assent is obtained.
- The patient is currently enrolled in study C1538d/312/AD/US or C1538/3044/AD/US and received modafinil treatment, continuously, for at least 12 months.
- The patient meets the protocol criteria for response at each of the last 2 visits of their previous study. Patients from study C1538d/312/AD/US must have at least a 25% reduction in Attention-Deficit/Hyperactivity Disorder Rating Scale - IV [ADHD-RS-IV] (Home Version) total score compared with the original baseline (this must be the baseline for a previous double-blind, placebo-controlled study of modafinil in ADHD). Patients from study C1538/3044/AD/US must have at least a 25% reduction in total score of the ADHD Index subscale of the Conners' Parent Rating Scale: Revised, Short Form (CPRS:R-S), compared with the baseline value from study C1538/3044/AD/US.
- The patient is in good health (except for diagnosis of ADHD) as determined by medical and psychiatric history, physical examination, electrocardiograms (ECGs), serum chemistry, hematology, urinalysis, and vital signs.
- Girls who are post-menarche or sexually active must have a negative urine pregnancy test at the baseline visit, must be using a medically acceptable method of birth control, and must agree to continue use of this method for the duration of the study (and for 30 days after participation in the study). Acceptable methods of birth control include the following: barrier method with spermicide; steroidal contraceptive (eg, oral, transdermal, implanted, or injected) in conjunction with a barrier method; intrauterine device (IUD); and abstinence.
- The patient has a parent or legal guardian who is willing to participate in the study.
-
Patients are excluded from participating in this study if 1 or more of the following criteria are met:
- The patient has a history or current diagnosis of pervasive developmental disorder, schizophrenia, or other psychotic disorders, or positive clinical assessment of current suicide risk or ideation.
- The patient has any current psychiatric co-morbidity that requires pharmacotherapy, including but not limited to depression or other mood disorder, anxiety disorder, or pervasive mental disorder.
- The patient currently uses any other prescription medication, other than modafinil, for ADHD (eg, amphetamine, dextroamphetamine, methylphenidate, pemoline, atomoxetine).
- Previous exposure to modafinil caused any clinically significant (drug-related) adverse reaction that led to withdrawal from the study, or which the investigator considers likely to put the patient at risk.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
UCI Child Development Center
🇺🇸Irvine, California, United States
Miami Research Associates
🇺🇸Miami, Florida, United States
Alpine Clinical Research
🇺🇸Boulder, Colorado, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
Amedica Research Institute, Inc.
🇺🇸Hialeah, Florida, United States
Kentucky Pediatric/Adult Research
🇺🇸Bardstown, Kentucky, United States
Child Neurology Associates
🇺🇸Atlanta, Georgia, United States
Four Rivers Clinical Research, Inc.
🇺🇸Paducah, Kentucky, United States
Clinical Neurophysiology Services
🇺🇸Troy, Michigan, United States
OCCI, Inc.
🇺🇸Salem, Oregon, United States
CNS Research Institute
🇺🇸Clementon, New Jersey, United States
Piedmont Neuropsychiatry
🇺🇸Charlotte, North Carolina, United States
Monarch Research Associates
🇺🇸Norfolk, Virginia, United States
Eastside Therapeutic Resource
🇺🇸Kirkland, Washington, United States
Pacific Institute Mental Health
🇺🇸Seattle, Washington, United States
The Clinical Study Center
🇺🇸Burlington, Vermont, United States
Clinical Study Centers, LLC
🇺🇸Little Rock, Arkansas, United States
Pahl Pharmaceutical Research, Inc.
🇺🇸Oklahoma City, Oklahoma, United States
University of California at San Francisco
🇺🇸San Francisco, California, United States
University of Nebraska
🇺🇸Omaha, Nebraska, United States
Triangle Neuropsychiatry
🇺🇸Durham, North Carolina, United States
Sarkis Family Psychiatry
🇺🇸Gainesville, Florida, United States
Michael J. Rieser, MD, PSC
🇺🇸Lexington, Kentucky, United States