Evaluate the Safety and Efficacy of Modafinil in Children and Adolescents With ADHD
A 1-Year, Open-Label, Flexible-Dosage Study to Evaluate the Safety and Continued Efficacy of Modafinil (Film-coated Tablet Formulation) in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (Followed by an Open-Ended Extension Period)
1 other identifier
interventional
N/A
1 country
57
Brief Summary
Primary objective of this study is to evaluate the safety of treatment with modafinil film-coated tablet.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2003
Typical duration for phase_3
57 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
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedJuly 26, 2012
July 1, 2012
3 years
September 14, 2005
July 25, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the safety of treatment with the modafinil film coated tablet.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cephalonlead
Study Sites (57)
University of Alabama Birmingh
Birmingham, Alabama, 35025, United States
Pivotal Research Center
Mesa, Arizona, 85210, United States
River Valley Neurology
Fort Smith, Arkansas, 72901, United States
Clinical Study Centers, LLC
Little Rock, Arkansas, 72205, United States
UCI Child Development Center
Irvine, California, 92612, United States
BMR HealthQuest
San Diego, California, 92123, United States
University of CA 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 Clinical Trials
Gainesville, Florida, 32607, United States
Amedica Research Inst.
Hialeah, Florida, 33013, United States
Children's Developmental Cente
Maitland, Florida, 32751, United States
Miami Research Associates
Miami, Florida, 33173, United States
Clinical Neuroscience Solution
West Palm Beach, Florida, 33407, 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
Cientifica at Prarie View
Newton, Kansas, 67114, United States
Vince and Associates Clinical
Overland Park, Kansas, 66211, 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
Four Rivers Clinical Research
Paducah, Kentucky, 42003, 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
Clinical Research Center of NV
Las Vegas, Nevada, 89014, United States
Radiant Research Las Vegas
Las Vegas, Nevada, 89146-5611, United States
CNS Research Institute
Clementon, New Jersey, 08021, United States
Children's Specialized Hospita
Toms River, New Jersey, 08755, United States
University of Buffalo
Buffalo, New York, 14214, United States
New York Psychiatric Inst
New York, New York, 10032, United States
University of Rochester
Rochester, New York, 14642, 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
OCCI Eugene
Eugene, Oregon, 97401, United States
Summit Research Network Inc.
Portland, Oregon, 97210, United States
OCCI, Inc.
Salem, Oregon, 97309, United States
CNS Research Institute PC
Philadelphia, Pennsylvania, 19149, United States
Primary Physicians Research
Pittsburgh, Pennsylvania, 15241, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Clinical Neuroscience Solution
Memphis, Tennessee, 38119, United States
Vanderbilt University Medical
Nashville, Tennessee, 37232, United States
Dallas Pediatric Neurology
Dallas, Texas, 75230, United States
UT Health Science Center
San Antonio, Texas, 78229-3900, 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
James A. Knutson, MD
Kirkland, Washington, 98033, United States
Pacific Institute of Mental He
Seattle, Washington, 98133-9009, United States
Marshfield Clinical Research
Marshfield, Wisconsin, 54449, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 22, 2005
Study Start
September 1, 2003
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
July 26, 2012
Record last verified: 2012-07