Clinical trial NCT00214981: Evaluate the Safety and Efficacy of Modafinil in Children and Adolescents With ADHD
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit/Hyperactivity Disorder
ADHD
Keywords: ADHD
Attention Deficit/Hyperactivity Disorder
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-22
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary objective of this study is to evaluate the safety of treatment with modafinil film-coated tablet.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the safety of treatment with the modafinil film coated tablet.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingh
state: Alabama
city: Mesa
country: United States
facility: Pivotal Research Center
state: Arizona
city: Fort Smith
country: United States
facility: River Valley Neurology
state: Arkansas
city: Little Rock
country: United States
facility: Clinical Study Centers, LLC
state: Arkansas
city: Irvine
country: United States
facility: UCI Child Development Center
state: California
city: San Diego
country: United States
facility: BMR HealthQuest
state: California
city: San Francisco
country: United States
facility: University of CA San Francisco
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research
state: Colorado
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: Amedica Research Inst.
state: Florida
city: Maitland
country: United States
facility: Children's Developmental Cente
state: Florida
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: West Palm Beach
country: United States
facility: Clinical Neuroscience Solution
state: Florida
city: Atlanta
country: United States
facility: Child Neurology Assoc.
state: Georgia
city: Decatur
country: United States
facility: Mountainview Center for Resear
state: Georgia
city: Boise
country: United States
facility: Foothills Psychiatry
state: Idaho
city: Northbrook
country: United States
facility: Consultants in Neurology, Ltd.
state: Illinois
city: Danville
country: United States
facility: Midwest Neurology, Inc.
state: Indiana
city: Newton
country: United States
facility: Cientifica at Prarie View
state: Kansas
city: Overland Park
country: United States
facility: Vince and Associates Clinical
state: Kansas
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Resea
state: Kentucky
city: Lexington
country: United States
facility: Michael J. Rieser, MD
state: Kentucky
city: Owensboro
country: United States
facility: Pedia Research, LLC
state: Kentucky
city: Paducah
country: United States
facility: Four Rivers Clinical Research
state: Kentucky
city: New Orleans
country: United States
facility: Dolby Providers, Inc.
state: Louisiana
city: Bethesda
country: United States
facility: NeuroScience, Inc.
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Troy
country: United States
facility: Clinical Neurophysiology Svcs
state: Michigan
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Research Center of NV
state: Nevada
city: Las Vegas
country: United States
facility: Radiant Research Las Vegas
state: Nevada
city: Clementon
country: United States
facility: CNS Research Institute
state: New Jersey
city: Toms River
country: United States
facility: Children's Specialized Hospita
state: New Jersey
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: New York
country: United States
facility: New York Psychiatric Inst
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Chapel Hill
country: United States
facility: North Carolina Neuropsychiatry
state: North Carolina
city: Charlotte
country: United States
facility: North Carolina Neuropsychiatry
state: North Carolina
city: Cincinnati
country: United States
facility: Psychiatric Professional Servi
state: Ohio
city: Oklahoma City
country: United States
facility: Pahl Pharmaceutical Research
state: Oklahoma
city: Eugene
country: United States
facility: OCCI Eugene
state: Oregon
city: Portland
country: United States
facility: Summit Research Network Inc.
state: Oregon
city: Salem
country: United States
facility: OCCI, Inc.
state: Oregon
city: Philadelphia
country: United States
facility: CNS Research Institute PC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Primary Physicians Research
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Memphis
country: United States
facility: Clinical Neuroscience Solution
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical
state: Tennessee
city: Dallas
country: United States
facility: Dallas Pediatric Neurology
state: Texas
city: San Antonio
country: United States
facility: UT Health Science Center
state: Texas
city: Salt Lake City
country: United States
facility: Radiant Research Salt Lake
state: Utah
city: Burlington
country: United States
facility: Otter Creek Clinical Studies
state: Vermont
city: Norfolk
country: United States
facility: Monarch Research Associates
state: Virginia
city: Kirkland
country: United States
facility: James A. Knutson, MD
state: Washington
city: Seattle
country: United States
facility: Pacific Institute of Mental He
state: Washington
city: Marshfield
country: United States
facility: Marshfield Clinical Research
state: Wisconsin
Study officials:
References: