Evaluate the Safety and Efficacy of Modafinil in Children and Adolescents With ADHD

ADHD Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00214981
• Other study ID #: C1538D/312/AD/US
• 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.