Primary objective of this study is to evaluate the safety of treatment with modafinil
film-coated tablet.
Inclusion Criteria: 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.
Exclusion Criteria: 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
University of Alabama Birmingh, Birmingham, Alabama 35025, United States
Pivotal Research Center, Mesa, Arizona 85210, United States
Clinical Study Centers, LLC, Little Rock, Arkansas 72205, United States
River Valley Neurology, Fort Smith, Arkansas 72901, United States
UCI Child Development Center, Irvine, California 92612, United States
BMR HealthQuest, San Diego, California 92123, United States
Encompass Clinical Research, Spring Valley, California 91978, United States
University of CA San Francisco, San Francisco, California 94143, United States
Alpine Clinical Research, Boulder, Colorado 80304, United States
Children's Developmental Cente, Maitland, Florida 32751, United States
Miami Research Associates, Miami, Florida 33173, United States
Sarkis Clinical Trials, Gainesville, Florida 32607, United States
Clinical Neuroscience Solution, West Palm Beach, Florida 33407, United States
Amedica Research Inst., Hialeah, Florida 33013, United States
Child Neurology Assoc., Atlanta, Georgia 30342, United States
Mountainview Center for Resear, Decatur, Georgia 30033, United States
Foothills Psychiatry, Boise, Idaho 83702, United States
Consultants in Neurology, Ltd., Northbrook, Illinois 60062, United States
Midwest Neurology, Inc., Danville, Indiana 46122, United States
Vince and Associates Clinical, Overland Park, Kansas 66211, United States
Cientifica at Prarie View, Newton, Kansas 67114, United States
Four Rivers Clinical Research, Paducah, Kentucky 42003, United States
Kentucky Pediatric/Adult Resea, Bardstown, Kentucky 40004, United States
Michael J. Rieser, MD, Lexington, Kentucky 40509, United States
Pedia Research, LLC, Owensboro, Kentucky 42301, United States
Dolby Providers, Inc., New Orleans, Louisiana 70128, United States
NeuroScience, Inc., Bethesda, Maryland 20814, United States
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Clinical Neurophysiology Svcs, Troy, Michigan 48085, United States
University of Nebraska, Omaha, Nebraska 68198-7630, United States
Radiant Research Las Vegas, Las Vegas, Nevada 89146-5611, United States
Clinical Research Center of NV, Las Vegas, Nevada 89014, United States
Children's Specialized Hospita, Toms River, New Jersey 08755, United States
CNS Research Institute, Clementon, New Jersey 08021, United States
University of Rochester, Rochester, New York 14642, United States
New York Psychiatric Inst, New York, New York 10032, United States
University of Buffalo, Buffalo, New York 14214, United States
North Carolina Neuropsychiatry, Chapel Hill, North Carolina 27514, United States
North Carolina Neuropsychiatry, Charlotte, North Carolina 28209, United States
Psychiatric Professional Servi, Cincinnati, Ohio 45267-0559, United States
Pahl Pharmaceutical Research, Oklahoma City, Oklahoma 73118, United States
Summit Research Network Inc., Portland, Oregon 97210, United States
OCCI, Inc., Salem, Oregon 97309, United States
OCCI Eugene, Eugene, Oregon 97401, United States
Primary Physicians Research, Pittsburgh, Pennsylvania 15241, United States
CNS Research Institute PC, Philadelphia, Pennsylvania 19149, United States
Rhode Island Hospital, Providence, Rhode Island 02903, United States
Vanderbilt University Medical, Nashville, Tennessee 37232, United States
Clinical Neuroscience Solution, Memphis, Tennessee 38119, United States
UT Health Science Center, San Antonio, Texas 78229-3900, United States
Dallas Pediatric Neurology, Dallas, Texas 75230, United States
Radiant Research Salt Lake, Salt Lake City, Utah 84107, United States
Otter Creek Clinical Studies, Burlington, Vermont 05401, United States
Monarch Research Associates, Norfolk, Virginia 23510, United States
Pacific Institute of Mental He, Seattle, Washington 98133-9009, United States
James A. Knutson, MD, Kirkland, Washington 98033, United States
Marshfield Clinical Research, Marshfield, Wisconsin 54449, United States
