Study to Evaluate the Efficacy of Modafinil Treatment in Patients With Attention Deficit Hyperactivity Disorder (ADHD) Who Are Responders to Modafinil Treatment
A 6-week, Double-Blind, Placebo-Controlled, Parallel Group Randomized Withdrawal Study to Evaluate the Continued Efficacy of Modafinil Treatment in Dosages up to 425mg/Day in Patients With Attention-Deficit/Hyperactivity Disorder Who Are Responders to Modafinil Treatment, Followed by a 12-Month Open-Label Extension Period
1 other identifier
interventional
120
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2006
Shorter than P25 for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 21, 2006
CompletedFirst Posted
Study publicly available on registry
June 23, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedMay 9, 2014
May 1, 2014
June 21, 2006
May 8, 2014
Conditions
Keywords
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cephalonlead
Study Sites (23)
Clinical Study Centers, LLC
Little Rock, Arkansas, 72205, United States
UCI Child Development Center
Irvine, California, 92612, United States
University of California at San Francisco
San Francisco, California, 94143, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Alpine Clinical Research
Boulder, Colorado, 80304, United States
Sarkis Family Psychiatry
Gainesville, Florida, 32607, United States
Amedica Research Institute, Inc.
Hialeah, Florida, 33013, United States
Miami Research Associates
Miami, Florida, 33173, United States
Child Neurology Associates
Atlanta, Georgia, 30342, United States
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, 40004, United States
Michael J. Rieser, MD, PSC
Lexington, Kentucky, 40509, United States
Four Rivers Clinical Research, Inc.
Paducah, Kentucky, 42001, United States
Clinical Neurophysiology Services
Troy, Michigan, 48085, United States
University of Nebraska
Omaha, Nebraska, 68198, United States
CNS Research Institute
Clementon, New Jersey, 08021, United States
Piedmont Neuropsychiatry
Charlotte, North Carolina, 28226, United States
Triangle Neuropsychiatry
Durham, North Carolina, 27717, United States
Pahl Pharmaceutical Research, Inc.
Oklahoma City, Oklahoma, 73118, United States
OCCI, Inc.
Salem, Oregon, 97301, United States
The Clinical Study Center
Burlington, Vermont, 05401, United States
Monarch Research Associates
Norfolk, Virginia, 23510, United States
Eastside Therapeutic Resource
Kirkland, Washington, 98033, United States
Pacific Institute Mental Health
Seattle, Washington, 98133, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 21, 2006
First Posted
June 23, 2006
Study Start
June 1, 2006
Study Completion
September 1, 2006
Last Updated
May 9, 2014
Record last verified: 2014-05