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)

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

Study Overview

• Status: Completed
• Conditions: Attention-deficit/Hyperactivity Disorder
• Intervention / Treatment: Drug: Lisdexamfetamine dimesylate; Drug: Methylphenidate Hydrochloride; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 464
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85254
      • Melmed Center
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Clinical Study Centers, LLC
  • California
    • National City, California, United States, 91950
      • Synergy Clinical Research Center
    • Orange, California, United States, 92868
      • Pacific Clinical Research Medical Group
    • Orange, California, United States, 92868
      • SDS Clinical Trials, Inc.
    • Rolling Hills Estates, California, United States, 90274
      • Peninsula Research Associates, Inc.
    • San Diego, California, United States, 92108
      • PCSD - Feighner Research
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
    • Santa Ana, California, United States, 92701
      • Neuropsychiatric Research Center of Orange County
    • Wildomar, California, United States, 92595
      • Elite Clinical Trials
  • Colorado
    • Colorado Springs, Colorado, United States, 80910
      • MCB Clinical Research Centers, LLC
  • Florida
    • Bradenton, Florida, United States, 34201
      • Florida Clinical Research Center, LLC
    • Gainesville, Florida, United States, 32608
      • Sarkis Clinical Trials
    • Hialeah, Florida, United States, 33013
      • Amedica Research Institute
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, INC.
    • Lauderhill, Florida, United States, 33319
      • Fidelity Clinical Research, Inc.
    • Maitland, Florida, United States, 32751
      • Florida Clinical Research Center, LLC
    • Miami, Florida, United States, 33161
      • Scientific Clinical Research, Inc.
    • Orlando, Florida, United States, 32806
      • Compass Research, LLC
    • Orlando, Florida, United States, 32806
      • Clinical Neuroscience Solutions, INC.
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials
    • West Palm Beach, Florida, United States, 33407
      • Janus Center For Psychiatric Research
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Atlanta Institute of Medicine and Research
  • Illinois
    • Libertyville, Illinois, United States, 60048
      • Capstone Clinical Research
    • Naperville, Illinois, United States, 60563
      • AMR Conventions Research
    • Naperville, Illinois, United States, 60563
      • AMR Baber Research Group, Inc.
    • Oak Brook, Illinois, United States, 60523
      • American Medical Research, Inc
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Hope Children's Hospital
    • Oak Park, Illinois, United States, 60301
      • Neuroscience Research Institute, Inc
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Psychiatric Associates
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • University of Kentucky
    • Paducah, Kentucky, United States, 42003
      • Four Rivers Clinical Research
  • Maryland
    • Rockville, Maryland, United States, 20852
      • Neuroscientific Insights
    • Rockville, Maryland, United States, 20882
      • Marc Hertzman MD, PC
  • Michigan
    • Rochester Hills, Michigan, United States, 48307
      • Rochester Center for Behavioral Medicine
    • Sterling Heights, Michigan, United States, 48314
      • Clinical Neurophysiology Services, PC
    • Troy, Michigan, United States, 48083
      • Behavioral Medical Center - Troy
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Precise Research Centers
  • Missouri
    • Gladstone, Missouri, United States, 64118
      • Comprehensive Psychiatric Associates
    • Saint Charles, Missouri, United States, 63301
      • St Charles Psychiatric Associates
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Premier Psychiatric Research Institute
    • Omaha, Nebraska, United States, 68105
      • University Of Nebraska Medical Center
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Center for Psychiatry and Behavioral Medicine, Inc.
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08002
      • Center for Emotional Fitness
    • Gibbsboro, New Jersey, United States, 08026
      • CRCNJ - Clinical Research Center of New Jersey
    • Mount Arlington, New Jersey, United States, 07856
      • Neurcognitive Institute
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Child and Family Study Center
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Innovis Health, LLC
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • North Coast Clinical Trials
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Dept. of Psychiatry & Behavioral
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Nisonger Center
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research Center
    • Mason, Ohio, United States, 45040
      • Professional Psychiatric Services
    • Wadsworth, Ohio, United States, 44281
      • Family Practice of Wadsworth, Inc.
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Cyn3rgy Research
    • Portland, Oregon, United States, 97210
      • Summit Research Network (Oregon) Inc.
    • Portland, Oregon, United States, 97210
      • Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
    • Salem, Oregon, United States, 97301
      • Oregon Center for Clinical Investigations, Inc.
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Carolina Clinical Trials, Inc.
    • Mount Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Research Strategies of Memphis, LLC
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Trials
    • Houston, Texas, United States, 77090
      • Red Oak Psychiatry Associates, PA
    • Houston, Texas, United States, 77081
      • Texas Center for Drug Development, Inc.
    • Houston, Texas, United States, 77008
      • Claghorn-Lesem Reseach Clinic, Ltd.
    • Lake Jackson, Texas, United States, 77586
      • R/D Clinical Research, Inc.
    • Lubbock, Texas, United States, 79423
      • Westex Clinical Investigations
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.
    • San Antonio, Texas, United States, 78229
      • University of Texas HSC at San Antonio Dept. of Psychiatry
    • Wharton, Texas, United States, 77488
      • Wharton Research Center, Inc.
  • Utah
    • Salt Lake City, Utah, United States, 84105
      • Psychiatric & Behavioral Solutions
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Child and Family Psychiatry Clinical
    • Herndon, Virginia, United States, 20170
      • Neuroscience, Inc.
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center
    • Kirkland, Washington, United States, 98033
      • Eastside Therapeutic Resource
    • Seattle, Washington, United States, 98104
      • Summit Research Network (Seattle), LLC
    • Spokane, Washington, United States, 99202
      • Rockwood Clinic, P.S.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Daily oral dosing in the AM for 8 weeks
ACTIVE_COMPARATOR: Methylphenidate Hydrochloride	Drug: Methylphenidate Hydrochloride; Daily oral dosing in the AM of optimized dose, ranging from 18-72 mg. 5 week dose optimization, 3 week dose maintenance; Other Names: OROS-MPH, Concerta
EXPERIMENTAL: Lisdexamfetamine Dimesylate	Drug: Lisdexamfetamine dimesylate; Daily oral dosing in the AM of optimized dose, ranging from 30- 70 mg. 5 week dose optimization, 3 week dose maintenance; Other Names: LDX, Vyvanse, SPD489

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 8 - Last Observation Carried Forward (LOCF)	Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.	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

Collaborators and Investigators

• Sponsor: Shire

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 17, 2012
• Primary Completion (ACTUAL): January 22, 2014
• Study Completion (ACTUAL): January 22, 2014

Study Registration Dates

• First Submitted: March 6, 2012
• First Submitted That Met QC Criteria: March 9, 2012
• First Posted (ESTIMATE): March 13, 2012

Study Record Updates

• Last Update Posted (ACTUAL): June 8, 2021
• Last Update Submitted That Met QC Criteria: May 16, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: ADHD
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Methylphenidate; Lisdexamfetamine Dimesylate
• Other Study ID Numbers: SPD489-405