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

Primary Purpose

Attention Deficit/Hyperactivity Disorder, ADHD

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Modafinil
Sponsored by
Cephalon
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit/Hyperactivity Disorder focused on measuring ADHD, Attention Deficit/Hyperactivity Disorder

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama Birmingh
  • Pivotal Research Center
  • River Valley Neurology
  • Clinical Study Centers, LLC
  • UCI Child Development Center
  • BMR HealthQuest
  • University of CA San Francisco
  • Encompass Clinical Research
  • Alpine Clinical Research
  • Sarkis Clinical Trials
  • Amedica Research Inst.
  • Children's Developmental Cente
  • Miami Research Associates
  • Clinical Neuroscience Solution
  • Child Neurology Assoc.
  • Mountainview Center for Resear
  • Foothills Psychiatry
  • Consultants in Neurology, Ltd.
  • Midwest Neurology, Inc.
  • Cientifica at Prarie View
  • Vince and Associates Clinical
  • Kentucky Pediatric/Adult Resea
  • Michael J. Rieser, MD
  • Pedia Research, LLC
  • Four Rivers Clinical Research
  • Dolby Providers, Inc.
  • NeuroScience, Inc.
  • Massachusetts General Hospital
  • Clinical Neurophysiology Svcs
  • University of Nebraska
  • Clinical Research Center of NV
  • Radiant Research Las Vegas
  • CNS Research Institute
  • Children's Specialized Hospita
  • University of Buffalo
  • New York Psychiatric Inst
  • University of Rochester
  • North Carolina Neuropsychiatry
  • North Carolina Neuropsychiatry
  • Psychiatric Professional Servi
  • Pahl Pharmaceutical Research
  • OCCI Eugene
  • Summit Research Network Inc.
  • OCCI, Inc.
  • CNS Research Institute PC
  • Primary Physicians Research
  • Rhode Island Hospital
  • Clinical Neuroscience Solution
  • Vanderbilt University Medical
  • Dallas Pediatric Neurology
  • UT Health Science Center
  • Radiant Research Salt Lake
  • Otter Creek Clinical Studies
  • Monarch Research Associates
  • James A. Knutson, MD
  • Pacific Institute of Mental He
  • Marshfield Clinical Research

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 14, 2005
Last Updated
July 25, 2012
Sponsor
Cephalon
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1. Study Identification

Unique Protocol Identification Number
NCT00214981
Brief Title
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

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cephalon

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit/Hyperactivity Disorder, ADHD
Keywords
ADHD, Attention Deficit/Hyperactivity Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Modafinil
Primary Outcome Measure Information:
Title
Evaluate the safety of treatment with the modafinil film coated tablet.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Alabama Birmingh
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35025
Country
United States
Facility Name
Pivotal Research Center
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
River Valley Neurology
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72901
Country
United States
Facility Name
Clinical Study Centers, LLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
UCI Child Development Center
City
Irvine
State/Province
California
ZIP/Postal Code
92612
Country
United States
Facility Name
BMR HealthQuest
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of CA San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Encompass Clinical Research
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Alpine Clinical Research
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Amedica Research Inst.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Children's Developmental Cente
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Clinical Neuroscience Solution
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Child Neurology Assoc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Mountainview Center for Resear
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Foothills Psychiatry
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Consultants in Neurology, Ltd.
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
Midwest Neurology, Inc.
City
Danville
State/Province
Indiana
ZIP/Postal Code
46122
Country
United States
Facility Name
Cientifica at Prarie View
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Vince and Associates Clinical
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Kentucky Pediatric/Adult Resea
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
Michael J. Rieser, MD
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Pedia Research, LLC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Four Rivers Clinical Research
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Dolby Providers, Inc.
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70128
Country
United States
Facility Name
NeuroScience, Inc.
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Clinical Neurophysiology Svcs
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
University of Nebraska
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7630
Country
United States
Facility Name
Clinical Research Center of NV
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89014
Country
United States
Facility Name
Radiant Research Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89146-5611
Country
United States
Facility Name
CNS Research Institute
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
Facility Name
Children's Specialized Hospita
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
University of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
Facility Name
New York Psychiatric Inst
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
North Carolina Neuropsychiatry
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
North Carolina Neuropsychiatry
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Psychiatric Professional Servi
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0559
Country
United States
Facility Name
Pahl Pharmaceutical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
OCCI Eugene
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Summit Research Network Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
OCCI, Inc.
City
Salem
State/Province
Oregon
ZIP/Postal Code
97309
Country
United States
Facility Name
CNS Research Institute PC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19149
Country
United States
Facility Name
Primary Physicians Research
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Clinical Neuroscience Solution
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Vanderbilt University Medical
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Dallas Pediatric Neurology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
UT Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Facility Name
Radiant Research Salt Lake
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Otter Creek Clinical Studies
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Monarch Research Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Facility Name
James A. Knutson, MD
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
Facility Name
Pacific Institute of Mental He
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133-9009
Country
United States
Facility Name
Marshfield Clinical Research
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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