Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder
A Phase 4, Randomized, Double-blind, Multicenter, Parallel-group, Active-controlled, Dose-optimization Safety and Efficacy Study of SPD489 (VYVANSE®) Compared With OROS-MPH (CONCERTA®) With a Placebo Reference Arm, in Adolescents Aged 13-17 Years With Attention-deficit/Hyperactivity Disorder (ADHD)
1 other identifier
interventional
464
1 country
79
Brief Summary
The purpose of this study is to determine effectiveness of Vyvanse compared to Concerta in adolescents with Attention-deficit/Hyperactivity Disorder (ADHD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2012
79 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2012
CompletedFirst Posted
Study publicly available on registry
March 13, 2012
CompletedStudy Start
First participant enrolled
April 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 22, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 22, 2014
CompletedResults Posted
Study results publicly available
December 11, 2014
CompletedJune 8, 2021
May 1, 2021
1.8 years
March 6, 2012
December 3, 2014
May 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 8
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. Higher score indicates more severe symptoms.
Baseline and week 8
Secondary Outcomes (4)
Percentage of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 8 - Last Observation Carried Forward (LOCF)
Week 8
Change From Baseline in Systolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment
Baseline and up to 8 Weeks
Change From Baseline in Diastolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment
Baseline and up to 8 weeks
Change From Baseline in Pulse Rate at up to 8 Weeks - Last on Treatment Assessment
Baseline and up to 8 weeks
Study Arms (3)
Lisdexamfetamine Dimesylate
EXPERIMENTALMethylphenidate Hydrochloride
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Daily oral dosing in the AM of optimized dose, ranging from 30- 70 mg. 5 week dose optimization, 3 week dose maintenance
Daily oral dosing in the AM of optimized dose, ranging from 18-72 mg. 5 week dose optimization, 3 week dose maintenance
Eligibility Criteria
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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (79)
Melmed Center
Scottsdale, Arizona, 85254, United States
Clinical Study Centers, LLC
Little Rock, Arkansas, 72211, United States
Synergy Clinical Research Center
National City, California, 91950, United States
Pacific Clinical Research Medical Group
Orange, California, 92868, United States
SDS Clinical Trials, Inc.
Orange, California, 92868, United States
Peninsula Research Associates, Inc.
Rolling Hills Estates, California, 90274, United States
PCSD - Feighner Research
San Diego, California, 92108, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Neuropsychiatric Research Center of Orange County
Santa Ana, California, 92701, United States
Elite Clinical Trials
Wildomar, California, 92595, United States
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, 80910, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, 34201, United States
Sarkis Clinical Trials
Gainesville, Florida, 32608, United States
Amedica Research Institute
Hialeah, Florida, 33013, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256, United States
Fidelity Clinical Research, Inc.
Lauderhill, Florida, 33319, United States
Florida Clinical Research Center, LLC
Maitland, Florida, 32751, United States
Scientific Clinical Research, Inc.
Miami, Florida, 33161, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
Janus Center for Psychiatric Research
West Palm Beach, Florida, 33407, United States
Atlanta Institute of Medicine and Research
Atlanta, Georgia, 30328, United States
Capstone Clinical Research
Libertyville, Illinois, 60048, United States
AMR Baber Research Group, Inc.
Naperville, Illinois, 60563, United States
AMR Conventions Research
Naperville, Illinois, 60563, United States
American Medical Research, Inc
Oak Brook, Illinois, 60523, United States
Advocate Hope Children's Hospital
Oak Lawn, Illinois, 60453, United States
Neuroscience Research Institute, Inc
Oak Park, Illinois, 60301, United States
Psychiatric Associates
Overland Park, Kansas, 66211, United States
University of Kentucky
Lexington, Kentucky, 40509, United States
Four Rivers Clinical Research
Paducah, Kentucky, 42003, United States
Neuroscientific InSights
Rockville, Maryland, 20852, United States
Marc Hertzman MD, PC
Rockville, Maryland, 20882, United States
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307, United States
Clinical Neurophysiology Services, PC
Sterling Heights, Michigan, 48314, United States
Behavioral Medical Center - Troy
Troy, Michigan, 48083, United States
Precise Research Centers
Flowood, Mississippi, 39232, United States
Comprehensive Psychiatric Associates
Gladstone, Missouri, 64118, United States
St Charles Psychiatric Associates
Saint Charles, Missouri, 63301, United States
Premier Psychiatric Research Institute
Lincoln, Nebraska, 68526, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68105, United States
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, 89128, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002, United States
CRCNJ - Clinical Research Center of New Jersey
Gibbsboro, New Jersey, 08026, United States
Neurcognitive Institute
Mount Arlington, New Jersey, 07856, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Duke Child and Family Study Center
Durham, North Carolina, 27705, United States
Innovis Health, LLC
Fargo, North Dakota, 58103, United States
North Coast Clinical Trials
Beachwood, Ohio, 44122, United States
University of Cincinnati Dept. of Psychiatry & Behavioral
Cincinnati, Ohio, 45219, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Ohio State University Nisonger Center
Columbus, Ohio, 43210, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
Professional Psychiatric Services
Mason, Ohio, 45040, United States
Family Practice of Wadsworth, Inc.
Wadsworth, Ohio, 44281, United States
Cyn3rgy Research
Gresham, Oregon, 97030, United States
Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
Portland, Oregon, 97210, United States
Summit Research Network (Oregon) Inc.
Portland, Oregon, 97210, United States
Oregon Center for Clinical Investigations, Inc.
Salem, Oregon, 97301, United States
Carolina Clinical Trials, Inc.
Charleston, South Carolina, 29407, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
Research Strategies of Memphis, LLC
Memphis, Tennessee, 38119, United States
FutureSearch Trials
Austin, Texas, 78731, United States
Claghorn-Lesem Reseach Clinic, Ltd.
Houston, Texas, 77008, United States
Texas Center for Drug Development, Inc.
Houston, Texas, 77081, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77586, United States
Westex Clinical Investigations
Lubbock, Texas, 79423, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
University of Texas HSC at San Antonio Dept. of Psychiatry
San Antonio, Texas, 78229, United States
Wharton Research Center, Inc.
Wharton, Texas, 77488, United States
Psychiatric & Behavioral Solutions
Salt Lake City, Utah, 84105, United States
University of Virginia Child and Family Psychiatry Clinical
Charlottesville, Virginia, 22903, United States
NeuroScience, Inc.
Herndon, Virginia, 20170, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Eastside Therapeutic Resource
Kirkland, Washington, 98033, United States
Summit Research Network (Seattle), LLC
Seattle, Washington, 98104, United States
Rockwood Clinic, P.S.
Spokane, Washington, 99202, United States
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: 28980198DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
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 17, 2012
Primary Completion
January 22, 2014
Study Completion
January 22, 2014
Last Updated
June 8, 2021
Results First Posted
December 11, 2014
Record last verified: 2021-05