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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:
NCT00214981
First received: September 14, 2005
Last updated: July 25, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention Phase
Attention Deficit/Hyperactivity Disorder
ADHD
Drug: Modafinil
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Evaluate the safety of treatment with the modafinil film coated tablet.

Study Start Date: September 2003
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214981

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

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT00214981     History of Changes
Other Study ID Numbers: C1538D/312/AD/US
Study First Received: September 14, 2005
Last Updated: July 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
ADHD
Attention Deficit/Hyperactivity Disorder

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Modafinil
Armodafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014