Evaluate the Safety and Efficacy of Modafinil in Children and Adolescents With ADHD
- Conditions
- Attention Deficit/Hyperactivity DisorderADHD
- Registration Number
- NCT00214981
- Lead Sponsor
- Cephalon
- Brief Summary
Primary objective of this study is to evaluate the safety of treatment with modafinil film-coated tablet.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Patients are included in the study if they participated in a previous qualifying study with modafinil and, in the opinion of the investigator, will continue to benefit from treatment with modafinil. In addition, the following criteria must be met:
- a boy or girl 6 to 17 years of age, inclusive, and English-speaking
- weight and height between the 5th and 95th percentile on the National Center for Health Statistics (NCHS) growth chart for age, height, and weight
- if more than 6 months since last dose of study drug, meets the full DSM-IV crieria for ADHD (combined typd, predominantly inattentive type, or predominantly hyperactive - impulsive type) at screening, as manifested by a psychiatric/clinical evaluation and confirmed by a structured diagnostic interview, namely, the Diagnostic Interview Schedule for Children, Fourth Edition (DISC-IV).
- are in good health (except for a diagnosis of ADHD) as determined by medical and psychiatric history, physical examination, ECG, serum chemistry, hematology, urinalysis
- girls of child bearing potential (Tanner scale >3) OR all girls 8 years of age and older have a negative urine pregnancy test at screening, 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). (NOTE: For conducting pregnancy tests, the investigator has the option of determining the sexual maturity all girls 8 years of age and older.) Acceptable methods of birth control include: barrier method with spermicide; steroidal contraceptive (eg, oral, transdermal, implanted, and injected) in conjunction with a barrier method; intrauterine device (IUD); or abstinence
- have 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:
- a history or current diagnosis of pervasive developmental disorder, schizophrenia, or other psychotic disorders, or a clinical assessment of current suicide risk
- any current psychiatric comorbidity, including but not limited to depression or other mood disorder, anxiety disorder, or pervasive mental disorder, that requires pharmacotherapy
- a clinically significant drug sensitivity to stimulants such as amphetamine, dextroamphetamine, methylphenidate, pemoline
- failure to respond to 2 or more adequate courses (dose or duration) of ADHD therapy
- use of any other prescription medications for ADHD (e.g., amphetamine, dextroamphetamine, methylphenidate, pemoline, atomoxetine) after the screening visit
- use of any MAO inhibitors or SSRIs within 2 weeks of the baseline visit
- hypertension, defined as follows (SBP = systolic blood pressure and DBP = diastolic blood pressure):
- ages 6-9 years SBP > 122mmHg or DBP>78mmHg
- ages 10-12 years SBP > 126mmHg or DBP>82mmHg
- ages 13-17 years SBP > 136mmHg or DBP>86mmHg
- hypotension, defined as sitting systolic blood pressure (taken after resting for 5 minutes) of less than 50mmHg for children under 12 years of age or less than 80mmHg for children 12 and older
- a sitting pulse outside the range of 60 through 115 bpm after resting for 5 minutes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Evaluate the safety of treatment with the modafinil film coated tablet.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (55)
UCI Child Development Center
🇺🇸Irvine, California, United States
Marshfield Clinical Research
🇺🇸Marshfield, Wisconsin, United States
Kentucky Pediatric/Adult Resea
🇺🇸Bardstown, Kentucky, United States
Pedia Research, LLC
🇺🇸Owensboro, Kentucky, United States
Dallas Pediatric Neurology
🇺🇸Dallas, Texas, United States
CNS Research Institute PC
🇺🇸Philadelphia, Pennsylvania, United States
NeuroScience, Inc.
🇺🇸Bethesda, Maryland, United States
Miami Research Associates
🇺🇸Miami, Florida, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Clinical Research Center of NV
🇺🇸Las Vegas, Nevada, United States
Pacific Institute of Mental He
🇺🇸Seattle, Washington, United States
Cientifica at Prarie View
🇺🇸Newton, Kansas, United States
Vince and Associates Clinical
🇺🇸Overland Park, Kansas, United States
University of Rochester
🇺🇸Rochester, New York, United States
University of Alabama Birmingh
🇺🇸Birmingham, Alabama, United States
University of CA San Francisco
🇺🇸San Francisco, California, United States
Pahl Pharmaceutical Research
🇺🇸Oklahoma City, Oklahoma, United States
University of Nebraska
🇺🇸Omaha, Nebraska, United States
Summit Research Network Inc.
🇺🇸Portland, Oregon, United States
Vanderbilt University Medical
🇺🇸Nashville, Tennessee, United States
UT Health Science Center
🇺🇸San Antonio, Texas, United States
Radiant Research Salt Lake
🇺🇸Salt Lake City, Utah, United States
River Valley Neurology
🇺🇸Fort Smith, Arkansas, United States
Clinical Neurophysiology Svcs
🇺🇸Troy, Michigan, United States
Pivotal Research Center
🇺🇸Mesa, Arizona, United States
CNS Research Institute
🇺🇸Clementon, New Jersey, United States
Psychiatric Professional Servi
🇺🇸Cincinnati, Ohio, United States
University of Buffalo
🇺🇸Buffalo, New York, United States
Midwest Neurology, Inc.
🇺🇸Danville, Indiana, United States
Children's Specialized Hospita
🇺🇸Toms River, New Jersey, United States
New York Psychiatric Inst
🇺🇸New York, New York, United States
Otter Creek Clinical Studies
🇺🇸Burlington, Vermont, United States
Four Rivers Clinical Research
🇺🇸Paducah, Kentucky, United States
Clinical Study Centers, LLC
🇺🇸Little Rock, Arkansas, United States
BMR HealthQuest
🇺🇸San Diego, California, United States
Amedica Research Inst.
🇺🇸Hialeah, Florida, United States
Alpine Clinical Research
🇺🇸Boulder, Colorado, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
Child Neurology Assoc.
🇺🇸Atlanta, Georgia, United States
Mountainview Center for Resear
🇺🇸Decatur, Georgia, United States
Clinical Neuroscience Solution
🇺🇸Memphis, Tennessee, United States
Children's Developmental Cente
🇺🇸Maitland, Florida, United States
Foothills Psychiatry
🇺🇸Boise, Idaho, United States
Consultants in Neurology, Ltd.
🇺🇸Northbrook, Illinois, United States
Radiant Research Las Vegas
🇺🇸Las Vegas, Nevada, United States
OCCI Eugene
🇺🇸Eugene, Oregon, United States
North Carolina Neuropsychiatry
🇺🇸Charlotte, North Carolina, United States
OCCI, Inc.
🇺🇸Salem, Oregon, United States
Primary Physicians Research
🇺🇸Pittsburgh, Pennsylvania, United States
Monarch Research Associates
🇺🇸Norfolk, Virginia, United States
James A. Knutson, MD
🇺🇸Kirkland, Washington, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
Dolby Providers, Inc.
🇺🇸New Orleans, Louisiana, United States
Michael J. Rieser, MD
🇺🇸Lexington, Kentucky, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States