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Study to Assess Satisfaction With Modafinil Treatment in Children and Adolescents With ADHD

Sponsor
Cephalon (Industry)
Overall Status
Completed
CT.gov ID
NCT00228540
Collaborator
(none)
39
Locations
12
Duration (Months)

Study Details

Study Description

Brief Summary

An 8-week, Open-Label Study to Characterize the Response to Modafinil (85mg Film-Coated Tablet) Treatment at Dosages up to 425mg/Day in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD) (With an Open-Ended Extension Period)

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An 8 Week, Open-Label Study to Characterize the Response to Modafinil (85 mg Film Coated Tablet) Treatment at Dosages Up to 425 mg/Day in Children and Adolescents With Attention Deficit/Hyperactivity Disorder (ADHD) (With an Open Ended Extension Period)
Study Start Date :
Sep 1, 2005
Actual Study Completion Date :
Sep 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    Patients are included in the study if all of the following criteria are met:

    • Written informed consent/assent is obtained.

    • The patient is a boy or girl 6 through 17 years of age (inclusive) at the screening visit, and both the patient and parent/legal guardian are English-speaking.

    • The patient has a previous diagnosis of ADHD and is currently receiving medication for the treatment of ADHD.

    • The patient, or the patient's parent/legal guardian, is dissatified (VAS score <50) with current ADHD medication (medication and reason for dissatisfaction documented).

    • The patient is in good health as determined by a medical or psychiatric history, screening physical examination, and clinical laboratory evaluations.

    • Girls who are postmenarche or sexually active, must have a negative urine pregnancy test prior to the baseline visit, 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). Acceptable methods of birth control include the following: barrier method with spermicide; steroidal contraceptive (eg, oral, transdermal, implant, or injected) in conjunction with a barrier method; intrauterine device (IUD); and abstinence.

    • The patient's parent/legal guardian must be willing and able to comply with study procedures and restrictions.

    Exclusion Criteria:

    Patients are excluded from participating in this study if 1 or more of the following criteria are met:

    • The patient has any current psychiatric comorbidity, including but not limited to depression or other mood disorder, or pervasive mental disorder, that requires pharmacotherapy.

    • The patient is satisfied with current ADHD medication and has no side effects.

    • The patient is using other prescription medications for ADHD with psychoactive properties (eg, amphetamine, dextroamphetamine, methylphenidate, pemoline, atomoxetine) after the baseline visit.

    • The patient has used monoamine oxidase (MAO) inhibitors within 1 week before the baseline visit.

    • The patient has used an investigational drug within 1 month before the screening visit.

    • The patient has a known clinically significant drug sensitivity to modafinil or any of its inactive ingredients.

    • The patient is pregnant or lactating. (Any patients becoming pregnant during the study will be withdrawn from study).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Melmed Center Scottsdale Arizona United States 85254
    2 UCI Child Development Center Irvine California United States 92612
    3 Pharmacology Research Institut Northridge California United States 91324
    4 Pacific Sleep Medicine Service San Diego California United States 92121
    5 Sarkis Clinical Trials Gainesville Florida United States 32607
    6 Clinical Neuroscience Solution Jacksonville Florida United States 32216
    7 Clinical Neurosciences Orlando Florida United States 32806
    8 Laszlo J. Mate, MD, PA West Palm Beach Florida United States 33407
    9 Northwest Behavioral Research Marietta Georgia United States 30060
    10 Pediatrics and Adolescent Woodstock Georgia United States 30189
    11 Loyola University Medical Center Department of Psychiatry Maywood Illinois United States 60153
    12 HALP Clinic and ADHD Research Northbrook Illinois United States 60062
    13 Cientifica, Inc. Wichita Kansas United States 67207
    14 Michael J. Rieser, MD Lexington Kentucky United States 40509
    15 Pedia Research, LLC Owensboro Kentucky United States 42301
    16 Louisiana Research Associates New Orleans Louisiana United States 70114
    17 Psycopharmacology Research - LSU Health Science Center Shreveport Louisiana United States 71103
    18 Massachusetts General Hospital Cambridge Massachusetts United States 02138
    19 Odyssey Research Dearborn Michigan United States 48126
    20 Hurley Medical Center Flint Michigan United States 48503
    21 ProMed HealthCare Kalamazoo Michigan United States 49008
    22 Regions Hospital St. Paul Minnesota United States 55101
    23 Odyssey Research McCook Nebraska United States 69001
    24 University of Nebraska Omaha Nebraska United States 68198-7630
    25 Bancroft Clinical Research Cherry Hill New Jersey United States 08034
    26 Hunterdon Pediatric Associates Flemington New Jersey United States 08822
    27 Odyssey Research Bismarck North Dakota United States 58501
    28 Prairie at Saint John's Fargo North Dakota United States 58104
    29 Odyssey Research Minot North Dakota United States 58701
    30 Cincinnati Children's Hospital Cincinnati Ohio United States 45229
    31 OCCI, Inc Salem Salem Oregon United States 97301
    32 Medical University of SC Charleston South Carolina United States 29425
    33 UT Medical Group Memphis Tennessee United States 38105
    34 Clinical Neuroscience Solution Memphis Tennessee United States 38119
    35 Claghorn-Lesem Research Bellaire Texas United States 77401
    36 The Clinical Study Ceneter Burlington Vermont United States 05401
    37 Dominion Clinical Research Midlothian Virginia United States 23112
    38 Advanced Pediatrics Vienna Virginia United States 22180
    39 Eastside Therapeutic Resource Kirkland Washington United States 98033

    Sponsors and Collaborators

    • Cephalon

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00228540
    Other Study ID Numbers:
    • C1538/3044/AD/US
    First Posted:
    Sep 29, 2005
    Last Update Posted:
    May 9, 2014
    Last Verified:
    May 1, 2014
    Additional relevant MeSH terms:
    Modafinil

    Study Results

    No Results Posted as of May 9, 2014