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

July 25, 2012 updated by: Cephalon

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Evaluate the safety of treatment with the modafinil film coated tablet.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cephalon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

July 26, 2012

Last Update Submitted That Met QC Criteria

July 25, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C1538D/312/AD/US

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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