Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder
NCT ID: NCT01552902
Last Updated: 2021-06-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
549 participants
INTERVENTIONAL
2012-04-03
2014-05-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lisdexamfetamine dimesylate
Lisdexamfetamine dimesylate
Daily oral dosing in the AM ranging from 30- 70 mg. 4 week forced dose titration, 2 week dose maintenance
Methylphenidate Hydrochloride
Methylphenidate Hydrochloride
Daily oral dosing in the AM ranging from 18-72 mg. 4 week force dose titration, 2 week dose maintenance
Placebo
Placebo
Daily oral dosing in the AM for 6 weeks
Interventions
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Lisdexamfetamine dimesylate
Daily oral dosing in the AM ranging from 30- 70 mg. 4 week forced dose titration, 2 week dose maintenance
Methylphenidate Hydrochloride
Daily oral dosing in the AM ranging from 18-72 mg. 4 week force dose titration, 2 week dose maintenance
Placebo
Daily oral dosing in the AM for 6 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject must weigh more than 79.5lb.
* The parent/LAR must be available at approximately 7:00AM (±2 hours) to dispense the dose of investigational product for the study duration.
* Subject, who is a female, must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test and a negative urine pregnancy test and agree to comply with any applicable contraceptive requirements of the protocol.
* Subject has an ADHD-RS-IV total score ≥28.
* Subject is able to swallow a capsule.
* Subject does not have hypertension and has a resting sitting blood pressure less than or equal to 135/85mmHg.
Exclusion Criteria
* Diagnosis of conduct disorder. Oppositional defiant disorder is not exclusionary.
* Subject is considered a suicide risk, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded.
* Subject is underweight or overweight.
* Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition. Mild, stable asthma is not exclusionary.
* Subject has a history of seizures (other than infantile febrile seizures), a chronic or current tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder.
* Subject has a known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place him/her at increased vulnerability to the sympathomimetic effects of a stimulant medication.
* Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
* Subject has any clinically significant ECG or clinically significant laboratory abnormality.
* Subject has current abnormal thyroid function, defined as abnormal thyroid stimulating hormone (TSH) and thyroxine (T4). Treatment with a stable dose of thyroid medication for at least 3 months is permitted.
* Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or to any excipients in the investigational product.
* Subject has a documented allergy, hypersensitivity, or intolerance to MPH or to any excipients in the reference product.
* Subject has failed to fully respond to an adequate course(s) (dose and duration) of MPH or amphetamine therapy.
* Subject has a history of suspected substance abuse or dependence disorder (excluding nicotine). Subjects with a lifetime history of amphetamine, cocaine, or other stimulant abuse and/or dependence will be excluded.
* Subject has a positive urine drug result.
* Subject has previously participated in this study or another clinical study involving SPD489/NRP104.
* Subject has glaucoma.
* Subject is required to take or anticipates the need to take medications that have CNS effects or affect performance, such as sedating antihistamines and decongestant sympathomimetics, or are monoamine oxidase inhibitors. Stable use of bronchodilator inhalers is not exclusionary.
* Subject is female and is pregnant or lactating.
* Subject is well controlled on his/her current ADHD medication.
* Subject has a pre-existing severe gastrointestinal tract narrowing.
13 Years
17 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Harmonex Neuroscience Research, Inc.
Dothan, Alabama, United States
Center for Advanced Improvement
Tucson, Arizona, United States
Clinical Study Centers, LLC
Little Rock, Arkansas, United States
Shanti Clinical Trials
Colton, California, United States
Sun Valley Research Center
Imperial, California, United States
Synergy Clinical Research Center
National City, California, United States
Pacific Sleep Medicine, A Medical Corporation
Oceanside, California, United States
Neuropsychiatric Research Center for Orange County
Orange, California, United States
Peninsula Research Associates
Rolling Hills Estates, California, United States
PCSD - Feighner Research
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
Encompass Clinical Research
Spring Valley, California, United States
Elite Clinical Trials
Wildomar, California, United States
IMMUNOe International Research Center
Centennial, Colorado, United States
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, United States
Coastal Connecticut Research, LLC
New London, Connecticut, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, United States
Amedica Research Institute, Inc
Hialeah, Florida, United States
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, United States
Sarkis Clinical Trials
Lake City, Florida, United States
Florida Clinical Research Center, LLC
Maitland, Florida, United States
Prevention & Strengthening Solutions, Inc.
Miami, Florida, United States
Scientific Clinical Research, Inc.
North Miami, Florida, United States
Medical Research Group of Central Florida
Orange City, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Atlanta Institute of Medicine & Research, Inc
Atlanta, Georgia, United States
Clinical Research Center, University of Illinois at Chicago
Chicago, Illinois, United States
Capstone Clinical Research
Libertyville, Illinois, United States
Baber Research Group
Naperville, Illinois, United States
Pedia Research, LLC
Newburgh, Indiana, United States
Psychiatric Associates
Overland Park, Kansas, United States
Pedia Research, LLC
Owensboro, Kentucky, United States
Louisiana Resarch Associates, Inc.
New Orleans, Louisiana, United States
Marc Hertzman, MD, PC
Rockville, Maryland, United States
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, United States
Clinical Neurophysiology Services, PC
Sterling Heights, Michigan, United States
Behavioral Medical Center - Troy
Troy, Michigan, United States
Comprehensive Psychiatric Associates
Gladstone, Missouri, United States
Psychiatric Care & Research Center
O'Fallon, Missouri, United States
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, United States
Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska, United States
University of Nebraska Medical Center Dept Of Psychiatry
Omaha, Nebraska, United States
Center for Psychiatry & Behavioral Medicine, Inc.
Las Vegas, Nevada, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, United States
The NeuroCognitive Institute
Mount Arlington, New Jersey, United States
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, United States
Brain Resource Center
New York, New York, United States
Mount Sinai School of Medicine/Dept of Psychiaatry
New York, New York, United States
Duke University medical Center/ Duke ADHD Program
Durham, North Carolina, United States
PMG Research of Wilmington
Wilmington, North Carolina, United States
University of Cincinnati College of Medicine/UCPC
Cincinnati, Ohio, United States
The Ohio State University Nisonger Center
Columbus, Ohio, United States
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, United States
Cyn3rgy Research
Gresham, Oregon, United States
Oregon Center for Clinical Investigations Inc
Portland, Oregon, United States
Summit Research Network
Portland, Oregon, United States
Oregon Center for Clinical Investigations, Inc
Salem, Oregon, United States
University Services
West Chester, Pennsylvania, United States
Omega Medical Research
Warwick, Rhode Island, United States
Rainbow Research, Inc.
Barnwell, South Carolina, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States
Research Across America/Psychiatric Medical Associates
Dallas, Texas, United States
Bayou City Research
Houston, Texas, United States
Claghorn-Lesem Research Clinic, Ltd.
Houston, Texas, United States
Clinical Trial Network
Houston, Texas, United States
Texas Center for Drug Development, Inc.
Houston, Texas, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, United States
Houston Clinical Trials, LLC
Houston, Texas, United States
Westex Clinical Investigations
Lubbock, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Univ of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Ericksen Research and Development - Westside Medical
Clinton, Utah, United States
University of Virginia Child and Family Psychiatry Clinic
Charlottesville, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Eastside Thereapeutic Resource
Kirkland, Washington, United States
Summit Research Network (Seattle), LLC
Seattle, Washington, United States
Rockwood Clinic, P.S.
Spokane, Washington, United States
True North Clinical Research
Kentville, Nova Scotia, Canada
The Kids Clinic
Whitby, Ontario, Canada
Schwerpunktpraxis fur Entwicklung und Lernen
Bamberg, , Germany
Klinik Fur Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie
Frankfurt, , Germany
Universitatsklinikum Freiburg
Freiburg im Breisgau, , Germany
Kinderarztpraxis Dr. Kaiser und Dr. MarineBe
Hamburg, , Germany
Zentralinstitut fur Seelische Gesundheit
Mannheim, , Germany
Medizinisches Studienzentrum Wurzburg
Würzburg, , Germany
Vadaskert Gyermekpszichiatriai Korhaz es Szakambulancia
Budapest, , Hungary
Bekes Megyei Pandy Kalman Korhaz
Gyula, , Hungary
Pecsi Megyei Jogu varos Egyesitett Egeszsegugyi Intezmenyek
Pécs, , Hungary
Szegedi Tudomanyegyetem
Szeged, , Hungary
Gillbergcentrum
Gothenburg, , Sweden
PRIMA Barn-och Vuxenpsykiatri Jarva
Spånga, , Sweden
Countries
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References
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Newcorn JH, Nagy P, Childress AC, Frick G, Yan B, Pliszka S. Randomized, Double-Blind, Placebo-Controlled Acute Comparator Trials of Lisdexamfetamine and Extended-Release Methylphenidate in Adolescents With Attention-Deficit/Hyperactivity Disorder. CNS Drugs. 2017 Nov;31(11):999-1014. doi: 10.1007/s40263-017-0468-2.
Other Identifiers
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2011-005452-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SPD489-406
Identifier Type: -
Identifier Source: org_study_id
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