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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00214981
Other study ID # C1538D/312/AD/US
Secondary ID
Status Completed
Phase Phase 3
First received September 14, 2005
Last updated July 25, 2012
Start date September 2003
Est. completion date September 2006

Study information

Verified date July 2012
Source Teva Pharmaceutical Industries
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date September 2006
Est. primary completion date September 2006
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 17 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • ADHD
  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit/Hyperactivity Disorder
  • Hyperkinesis

Intervention

Drug:
Modafinil


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Cephalon

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate the safety of treatment with the modafinil film coated tablet.
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