Study to Evaluate the Efficacy of Modafinil Treatment in Patients With Attention Deficit Hyperactivity Disorder (ADHD) Who Are Responders to Modafinil Treatment

Completed · Phase 3

Conditions studied: Attention Deficit Hyperactivity Disorder

In brief

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.

Key facts

Study ID

NCT00343811

Run by

Cephalon

People needed

120

Starts

2006-06-01

Expected to finish

2006-09-01

Last updated by the study team

2014-05-09

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Study Centers, LLC — Little Rock, Arkansas, United States
• UCI Child Development Center — Irvine, California, United States
• University of California at San Francisco — San Francisco, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• Alpine Clinical Research — Boulder, Colorado, United States
• Sarkis Family Psychiatry — Gainesville, Florida, United States
• Amedica Research Institute, Inc. — Hialeah, Florida, United States
• Miami Research Associates — Miami, Florida, United States
• Child Neurology Associates — Atlanta, Georgia, United States
• Kentucky Pediatric/Adult Research — Bardstown, Kentucky, United States
• Michael J. Rieser, MD, PSC — Lexington, Kentucky, United States
• Four Rivers Clinical Research, Inc. — Paducah, Kentucky, United States
• Clinical Neurophysiology Services — Troy, Michigan, United States
• University of Nebraska — Omaha, Nebraska, United States
• CNS Research Institute — Clementon, New Jersey, United States
• Piedmont Neuropsychiatry — Charlotte, North Carolina, United States
• Triangle Neuropsychiatry — Durham, North Carolina, United States
• Pahl Pharmaceutical Research, Inc. — Oklahoma City, Oklahoma, United States
• OCCI, Inc. — Salem, Oregon, United States
• The Clinical Study Center — Burlington, Vermont, United States
• Monarch Research Associates — Norfolk, Virginia, United States
• Eastside Therapeutic Resource — Kirkland, Washington, United States
• Pacific Institute Mental Health — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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