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Attention-deficit/Hyperactivity DisorderPhase 4NCT01552902

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

A Phase 4 study testing Lisdexamfetamine dimesylate and Methylphenidate Hydrochloride in people with Attention-deficit/Hyperactivity Disorder, run by Shire at 95 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 13 to 17 years
Conditions the study is for
Attention-deficit/Hyperactivity Disorder
What is being tested?
Lisdexamfetamine dimesylate and Methylphenidate Hydrochloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
549 participants
Where
95 sitesin 5 countries
Study dates
3 Apr 2012to 22 May 2014
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 21Show fewer
  • 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.

Trial locations and contacts

95 sites in 5 countries.

95 sites in 5 countries

United States81 sites

  • Albuquerque Neuroscience, Inc.

    Albuquerque, New Mexico, 87109

  • Atlanta Institute of Medicine & Research, Inc

    Atlanta, Georgia, 30328

  • Rainbow Research, Inc.

    Barnwell, South Carolina, 29812

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Florida Clinical Research Center, LLC

    Bradenton, Florida, 34201

  • IMMUNOe International Research Center

    Centennial, Colorado, 80112

  • University of Virginia Child and Family Psychiatry Clinic

    Charlottesville, Virginia, 22903

  • Center for Emotional Fitness

    Cherry Hill, New Jersey, 08002

  • Clinical Research Center, University of Illinois at Chicago

    Chicago, Illinois, 60608

  • University of Cincinnati College of Medicine/UCPC

    Cincinnati, Ohio, 45219

  • Ericksen Research and Development - Westside Medical

    Clinton, Utah, 84015

  • MCB Clinical Research Centers, LLC

    Colorado Springs, Colorado, 80910

  • Shanti Clinical Trials

    Colton, California, 92324

  • The Ohio State University Nisonger Center

    Columbus, Ohio, 43210

  • FutureSearch Trials of Dallas, LP

    Dallas, Texas, 75231

  • Research Across America/Psychiatric Medical Associates

    Dallas, Texas, 75234

  • Harmonex Neuroscience Research, Inc.

    Dothan, Alabama, 36303

  • Duke University medical Center/ Duke ADHD Program

    Durham, North Carolina, 27705

  • Comprehensive Psychiatric Associates

    Gladstone, Missouri, 64118

  • Cyn3rgy Research

    Gresham, Oregon, 97030

  • Amedica Research Institute, Inc

    Hialeah, Florida, 33013

  • Bayou City Research

    Houston, Texas, 77007

  • Claghorn-Lesem Research Clinic, Ltd.

    Houston, Texas, 77008

  • Clinical Trial Network

    Houston, Texas, 77074

  • Texas Center for Drug Development, Inc.

    Houston, Texas, 77081

  • Red Oak Psychiatry Associates, PA

    Houston, Texas, 77090

  • Houston Clinical Trials, LLC

    Houston, Texas, 77098

  • Sun Valley Research Center

    Imperial, California, 92251

  • Clinical Neuroscience Solutions, Inc

    Jacksonville, Florida, 32256

  • Eastside Thereapeutic Resource

    Kirkland, Washington, 98033

  • Sarkis Clinical Trials

    Lake City, Florida, 32055

  • Center for Psychiatry & Behavioral Medicine, Inc.

    Las Vegas, Nevada, 89128

  • Capstone Clinical Research

    Libertyville, Illinois, 60048

  • Premier Psychiatric Research Institute, LLC

    Lincoln, Nebraska, 68526

  • Clinical Study Centers, LLC

    Little Rock, Arkansas, 72211

  • Westex Clinical Investigations

    Lubbock, Texas, 79423

  • Florida Clinical Research Center, LLC

    Maitland, Florida, 32751

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee, 38119

  • Prevention & Strengthening Solutions, Inc.

    Miami, Florida, 33169

  • The NeuroCognitive Institute

    Mount Arlington, New Jersey, 07856

  • Baber Research Group

    Naperville, Illinois, 60563

  • Synergy Clinical Research Center

    National City, California, 91950

  • Coastal Connecticut Research, LLC

    New London, Connecticut, 06320

  • Louisiana Resarch Associates, Inc.

    New Orleans, Louisiana, 70114

  • Brain Resource Center

    New York, New York, 10023

  • Mount Sinai School of Medicine/Dept of Psychiaatry

    New York, New York, 10029

  • Pedia Research, LLC

    Newburgh, Indiana, 47630

  • Scientific Clinical Research, Inc.

    North Miami, Florida, 33161

  • Psychiatric Care & Research Center

    O'Fallon, Missouri, 63368

  • Pacific Sleep Medicine, A Medical Corporation

    Oceanside, California, 92054

  • University of Nebraska Medical Center Dept Of Psychiatry

    Omaha, Nebraska, 68198

  • Neuropsychiatric Research Center for Orange County

    Orange, California, 92868

  • Medical Research Group of Central Florida

    Orange City, Florida, 32763

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32806

  • Compass Research, LLC

    Orlando, Florida, 32806

  • Psychiatric Associates

    Overland Park, Kansas, 66211

  • Pedia Research, LLC

    Owensboro, Kentucky, 42301

  • Oregon Center for Clinical Investigations Inc

    Portland, Oregon, 97210

  • Summit Research Network

    Portland, Oregon, 97210

  • Rochester Center for Behavioral Medicine

    Rochester Hills, Michigan, 48307

  • Marc Hertzman, MD, PC

    Rockville, Maryland, 20852

  • Peninsula Research Associates

    Rolling Hills Estates, California, 90274

  • St. Charles Psychiatric Associates - Midwest Research Group

    Saint Charles, Missouri, 63301

  • Oregon Center for Clinical Investigations, Inc

    Salem, Oregon, 97301

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • Univ of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • PCSD - Feighner Research

    San Diego, California, 92108

  • University of California, San Francisco

    San Francisco, California, 94143

  • Summit Research Network (Seattle), LLC

    Seattle, Washington, 98104

  • Miami Research Associates

    South Miami, Florida, 33143

  • Rockwood Clinic, P.S.

    Spokane, Washington, 99202

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • Clinical Neurophysiology Services, PC

    Sterling Heights, Michigan, 48314

  • Stedman Clinical Trials

    Tampa, Florida, 33613

  • Behavioral Medical Center - Troy

    Troy, Michigan, 48083

  • Center for Advanced Improvement

    Tucson, Arizona, 85719

  • Tulsa Clinical Research, LLC

    Tulsa, Oklahoma, 74104

  • Omega Medical Research

    Warwick, Rhode Island, 02886

  • University Services

    West Chester, Pennsylvania, 19380

  • Elite Clinical Trials

    Wildomar, California, 92595

  • PMG Research of Wilmington

    Wilmington, North Carolina, 28401

Other trials in United States

Germany6 sites

  • Schwerpunktpraxis fur Entwicklung und Lernen

    Bamberg, 96047

  • Klinik Fur Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie

    Frankfurt, 15236

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, 79104

  • Kinderarztpraxis Dr. Kaiser und Dr. MarineBe

    Hamburg, 22415

  • Zentralinstitut fur Seelische Gesundheit

    Mannheim, 68159

  • Medizinisches Studienzentrum Wurzburg

    Würzburg, 97070

Other trials in Germany

Hungary4 sites

  • Vadaskert Gyermekpszichiatriai Korhaz es Szakambulancia

    Budapest, H-1021

  • Bekes Megyei Pandy Kalman Korhaz

    Gyula, H-5700

  • Pecsi Megyei Jogu varos Egyesitett Egeszsegugyi Intezmenyek

    Pécs, H-7632

  • Szegedi Tudomanyegyetem

    Szeged, H-6725

Other trials in Hungary

Canada2 sites

  • True North Clinical Research

    Kentville, Nova Scotia, B4N 4K9

  • The Kids Clinic

    Whitby, Ontario, L1N 2L1

Other trials in Canada

Sweden2 sites

  • Gillbergcentrum

    Gothenburg, 411 19

  • PRIMA Barn-och Vuxenpsykiatri Jarva

    Spånga, 163 74

Other trials in Sweden

About this study

Official title: A Phase 4, Randomized, Double-blind, Multicenter, Parallel-group, Active-controlled, Forced-dose Titration, 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).

Being tested
Lisdexamfetamine dimesylate, Methylphenidate Hydrochloride, Placebo
Keywords
ADHD
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lisdexamfetamine dimesylateDrug

    Also called SPD489, Vyvanse, LDX

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

  • Methylphenidate HydrochlorideDrug

    Also called Concerta, OROS-MPH

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

  • PlaceboDrug

    Daily oral dosing in the AM for 6 weeks

Study groups in NCT01552902
Study groupRoleWhat they receive
Lisdexamfetamine dimesylateExperimentalNot described
Receives: Drug: Lisdexamfetamine dimesylate
Methylphenidate HydrochlorideActive comparatorNot described
Receives: Drug: Methylphenidate Hydrochloride
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 6

Secondary outcomes (1)

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

    The Clinical Global Impressions Scale permits a global evaluation of the participant's severity of illness and improvement over time. The scale included a severity of illness item and a global improvement item. The investigator performed the CGI-I to rate the improvement of a participant's ADHD symptoms based on a 7-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse.). Percentage of participants with an improved measurement (response of very much improved and much improved) is reported.

    Measured: Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2012 (estimated)
  2. Study start3 Apr 2012
  3. Primary completion22 May 2014
  4. Study completion22 May 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
549 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01552902
Sponsor's protocol ID
SPD489-406
Other IDs
2011-005452-34
Status last verified
May 2021
First submitted
6 Mar 2012
Last updated
10 Jun 2021
Data monitoring committee
No

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.

    PubMed 28980198

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lisdexamfetamine dimesylate and Methylphenidate Hydrochloride in people with Attention-deficit/Hyperactivity Disorder, run by Shire at 95 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States, Germany, Hungary, Canada, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 6 (time frame: Baseline, Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01552902, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.

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