Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder

NCT01552902 | Completed Phase 4 Results

• 2 other identifiers: SPD489-4062011-005452-34
• Study Type: interventional
• Target: 549
• Locations: 5 countries
• Sites: 95

Brief Summary

The purpose of this study is to determine effectiveness of Vyvanse compared to Concerta in adolescents with Attention-deficit/Hyperactivity Disorder (ADHD).

Conditions

Attention-deficit/Hyperactivity Disorder

Keywords

ADHD

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 6

  The ADHD-RS-IV was developed to measure the behaviors of children with ADHD and is commonly used in clinical studies of ADHD. The ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54, Higher score = more severe symptoms.

  Baseline, Week 6

Secondary Outcomes (1)

• Percentage of Participants With an Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 6

  Week 6

Other Outcomes (3)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

  Baseline up to 3 days after last dose (last dose at Week 6)

• Change From Baseline in Blood Pressure at Week 6

  Baseline, Week 6

• Change From Baseline in Pulse Rate at Week 6

  Baseline, Week 6

Study Arms (3)

Lisdexamfetamine dimesylate

EXPERIMENTAL

Drug: Lisdexamfetamine dimesylate

Methylphenidate Hydrochloride

ACTIVE COMPARATOR

Drug: Methylphenidate Hydrochloride

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Lisdexamfetamine dimesylate DRUG

Daily oral dosing in the AM ranging from 30- 70 mg. 4 week forced dose titration, 2 week dose maintenance

Also known as: SPD489, Vyvanse, LDX

Lisdexamfetamine dimesylate

Methylphenidate Hydrochloride DRUG

Daily oral dosing in the AM ranging from 18-72 mg. 4 week force dose titration, 2 week dose maintenance

Also known as: Concerta, OROS-MPH

Methylphenidate Hydrochloride

Placebo DRUG

Daily oral dosing in the AM for 6 weeks

Placebo

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subject must be 13-17 years of age, inclusive, at the time of consent.
• 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.

You may not qualify if:

• Subject has a current, controlled (with medications prohibited in this study) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any significant comorbid Axis II disorder or significant Axis I disorder (such as post traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, depressive or anxiety disorder.
• 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 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.

Sponsors & Collaborators

• Shire: lead

Study Sites (95)

Harmonex Neuroscience Research, Inc.

Dothan, Alabama, 36303, United States

Location

Center for Advanced Improvement

Tucson, Arizona, 85719, United States

Location

Clinical Study Centers, LLC

Little Rock, Arkansas, 72211, United States

Location

Shanti Clinical Trials

Colton, California, 92324, United States

Location

Sun Valley Research Center

Imperial, California, 92251, United States

Location

Synergy Clinical Research Center

National City, California, 91950, United States

Location

Pacific Sleep Medicine, A Medical Corporation

Oceanside, California, 92054, United States

Location

Neuropsychiatric Research Center for Orange County

Orange, California, 92868, United States

Location

Peninsula Research Associates

Rolling Hills Estates, California, 90274, United States

Location

PCSD - Feighner Research

San Diego, California, 92108, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Encompass Clinical Research

Spring Valley, California, 91978, United States

Location

Elite Clinical Trials

Wildomar, California, 92595, United States

Location

IMMUNOe International Research Center

Centennial, Colorado, 80112, United States

Location

MCB Clinical Research Centers, LLC

Colorado Springs, Colorado, 80910, United States

Location

Coastal Connecticut Research, LLC

New London, Connecticut, 06320, United States

Location

Florida Clinical Research Center, LLC

Bradenton, Florida, 34201, United States

Location

Amedica Research Institute, Inc

Hialeah, Florida, 33013, United States

Location

Clinical Neuroscience Solutions, Inc

Jacksonville, Florida, 32256, United States

Location

Sarkis Clinical Trials

Lake City, Florida, 32055, United States

Location

Florida Clinical Research Center, LLC

Maitland, Florida, 32751, United States

Location

Prevention & Strengthening Solutions, Inc.

Miami, Florida, 33169, United States

Location

Scientific Clinical Research, Inc.

North Miami, Florida, 33161, United States

Location

Medical Research Group of Central Florida

Orange City, Florida, 32763, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32806, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Stedman Clinical Trials

Tampa, Florida, 33613, United States

Location

Atlanta Institute of Medicine & Research, Inc

Atlanta, Georgia, 30328, United States

Location

Clinical Research Center, University of Illinois at Chicago

Chicago, Illinois, 60608, United States

Location

Capstone Clinical Research

Libertyville, Illinois, 60048, United States

Location

Baber Research Group

Naperville, Illinois, 60563, United States

Location

Pedia Research, LLC

Newburgh, Indiana, 47630, United States

Location

Psychiatric Associates

Overland Park, Kansas, 66211, United States

Location

Pedia Research, LLC

Owensboro, Kentucky, 42301, United States

Location

Louisiana Resarch Associates, Inc.

New Orleans, Louisiana, 70114, United States

Location

Marc Hertzman, MD, PC

Rockville, Maryland, 20852, United States

Location

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, 48307, United States

Location

Clinical Neurophysiology Services, PC

Sterling Heights, Michigan, 48314, United States

Location

Behavioral Medical Center - Troy

Troy, Michigan, 48083, United States

Location

Comprehensive Psychiatric Associates

Gladstone, Missouri, 64118, United States

Location

Psychiatric Care & Research Center

O'Fallon, Missouri, 63368, United States

Location

St. Charles Psychiatric Associates - Midwest Research Group

Saint Charles, Missouri, 63301, United States

Location

Premier Psychiatric Research Institute, LLC

Lincoln, Nebraska, 68526, United States

Location

University of Nebraska Medical Center Dept Of Psychiatry

Omaha, Nebraska, 68198, United States

Location

Center for Psychiatry & Behavioral Medicine, Inc.

Las Vegas, Nevada, 89128, United States

Location

Center for Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

The NeuroCognitive Institute

Mount Arlington, New Jersey, 07856, United States

Location

Albuquerque Neuroscience, Inc.

Albuquerque, New Mexico, 87109, United States

Location

Brain Resource Center

New York, New York, 10023, United States

Location

Mount Sinai School of Medicine/Dept of Psychiaatry

New York, New York, 10029, United States

Location

Duke University medical Center/ Duke ADHD Program

Durham, North Carolina, 27705, United States

Location

PMG Research of Wilmington

Wilmington, North Carolina, 28401, United States

Location

University of Cincinnati College of Medicine/UCPC

Cincinnati, Ohio, 45219, United States

Location

The Ohio State University Nisonger Center

Columbus, Ohio, 43210, United States

Location

Tulsa Clinical Research, LLC

Tulsa, Oklahoma, 74104, United States

Location

Cyn3rgy Research

Gresham, Oregon, 97030, United States

Location

Oregon Center for Clinical Investigations Inc

Portland, Oregon, 97210, United States

Location

Summit Research Network

Portland, Oregon, 97210, United States

Location

Oregon Center for Clinical Investigations, Inc

Salem, Oregon, 97301, United States

Location

University Services

West Chester, Pennsylvania, 19380, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Rainbow Research, Inc.

Barnwell, South Carolina, 29812, United States

Location

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, 38119, United States

Location

FutureSearch Trials of Dallas, LP

Dallas, Texas, 75231, United States

Location

Research Across America/Psychiatric Medical Associates

Dallas, Texas, 75234, United States

Location

Bayou City Research

Houston, Texas, 77007, United States

Location

Claghorn-Lesem Research Clinic, Ltd.

Houston, Texas, 77008, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

Texas Center for Drug Development, Inc.

Houston, Texas, 77081, United States

Location

Red Oak Psychiatry Associates, PA

Houston, Texas, 77090, United States

Location

Houston Clinical Trials, LLC

Houston, Texas, 77098, United States

Location

Westex Clinical Investigations

Lubbock, Texas, 79423, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Univ of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Ericksen Research and Development - Westside Medical

Clinton, Utah, 84015, United States

Location

University of Virginia Child and Family Psychiatry Clinic

Charlottesville, Virginia, 22903, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Eastside Thereapeutic Resource

Kirkland, Washington, 98033, United States

Location

Summit Research Network (Seattle), LLC

Seattle, Washington, 98104, United States

Location

Rockwood Clinic, P.S.

Spokane, Washington, 99202, United States

Location

True North Clinical Research

Kentville, Nova Scotia, B4N 4K9, Canada

Location

The Kids Clinic

Whitby, Ontario, L1N 2L1, Canada

Location

Schwerpunktpraxis fur Entwicklung und Lernen

Bamberg, 96047, Germany

Location

Klinik Fur Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie

Frankfurt, 15236, Germany

Location

Universitatsklinikum Freiburg

Freiburg im Breisgau, 79104, Germany

Location

Kinderarztpraxis Dr. Kaiser und Dr. MarineBe

Hamburg, 22415, Germany

Location

Zentralinstitut fur Seelische Gesundheit

Mannheim, 68159, Germany

Location

Medizinisches Studienzentrum Wurzburg

Würzburg, 97070, Germany

Location

Vadaskert Gyermekpszichiatriai Korhaz es Szakambulancia

Budapest, H-1021, Hungary

Location

Bekes Megyei Pandy Kalman Korhaz

Gyula, H-5700, Hungary

Location

Pecsi Megyei Jogu varos Egyesitett Egeszsegugyi Intezmenyek

Pécs, H-7632, Hungary

Location

Szegedi Tudomanyegyetem

Szeged, H-6725, Hungary

Location

Gillbergcentrum

Gothenburg, 411 19, Sweden

Location

PRIMA Barn-och Vuxenpsykiatri Jarva

Spånga, 163 74, Sweden

Location

Related Publications (1)

• 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.

  PMID: 28980198 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Lisdexamfetamine Dimesylate; Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 13, 2012
• Study Start: April 3, 2012
• Primary Completion: May 22, 2014
• Study Completion: May 22, 2014
• Last Updated: June 10, 2021
• Results First Posted: March 18, 2015

Record last verified: 2021-05

Locations

CA (2); HU (4); DE (6); US (81); SE (2)