Clinical trial NCT01552902: Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention-deficit/Hyperactivity Disorder
Keywords: ADHD
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2012-03-13
Enrollment: 549
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 6
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Percentage of Participants With an Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 6
timeFrame: Week 6
Other outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
timeFrame: Baseline up to 3 days after last dose (last dose at Week 6)
measure: Change From Baseline in Blood Pressure at Week 6
timeFrame: Baseline, Week 6
measure: Change From Baseline in Pulse Rate at Week 6
timeFrame: Baseline, Week 6
Locations:
city: Dothan
country: United States
facility: Harmonex Neuroscience Research, Inc.
state: Alabama
city: Tucson
country: United States
facility: Center for Advanced Improvement
state: Arizona
city: Little Rock
country: United States
facility: Clinical Study Centers, LLC
state: Arkansas
city: Colton
country: United States
facility: Shanti Clinical Trials
state: California
city: Imperial
country: United States
facility: Sun Valley Research Center
state: California
city: National City
country: United States
facility: Synergy Clinical Research Center
state: California
city: Oceanside
country: United States
facility: Pacific Sleep Medicine, A Medical Corporation
state: California
city: Orange
country: United States
facility: Neuropsychiatric Research Center for Orange County
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates
state: California
city: San Diego
country: United States
facility: PCSD - Feighner Research
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Wildomar
country: United States
facility: Elite Clinical Trials
state: California
city: Centennial
country: United States
facility: IMMUNOe International Research Center
state: Colorado
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers, LLC
state: Colorado
city: New London
country: United States
facility: Coastal Connecticut Research, LLC
state: Connecticut
city: Bradenton
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Hialeah
country: United States
facility: Amedica Research Institute, Inc
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Lake City
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Miami
country: United States
facility: Prevention & Strengthening Solutions, Inc.
state: Florida
city: North Miami
country: United States
facility: Scientific Clinical Research, Inc.
state: Florida
city: Orange City
country: United States
facility: Medical Research Group of Central Florida
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: Atlanta
country: United States
facility: Atlanta Institute of Medicine & Research, Inc
state: Georgia
city: Chicago
country: United States
facility: Clinical Research Center, University of Illinois at Chicago
state: Illinois
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Naperville
country: United States
facility: Baber Research Group
state: Illinois
city: Newburgh
country: United States
facility: Pedia Research, LLC
state: Indiana
city: Overland Park
country: United States
facility: Psychiatric Associates
state: Kansas
city: Owensboro
country: United States
facility: Pedia Research, LLC
state: Kentucky
city: New Orleans
country: United States
facility: Louisiana Resarch Associates, Inc.
state: Louisiana
city: Rockville
country: United States
facility: Marc Hertzman, MD, PC
state: Maryland
city: Rochester Hills
country: United States
facility: Rochester Center for Behavioral Medicine
state: Michigan
city: Sterling Heights
country: United States
facility: Clinical Neurophysiology Services, PC
state: Michigan
city: Troy
country: United States
facility: Behavioral Medical Center - Troy
state: Michigan
city: Gladstone
country: United States
facility: Comprehensive Psychiatric Associates
state: Missouri
city: O'Fallon
country: United States
facility: Psychiatric Care & Research Center
state: Missouri
city: Saint Charles
country: United States
facility: St. Charles Psychiatric Associates - Midwest Research Group
state: Missouri
city: Lincoln
country: United States
facility: Premier Psychiatric Research Institute, LLC
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center Dept Of Psychiatry
state: Nebraska
city: Las Vegas
country: United States
facility: Center for Psychiatry & Behavioral Medicine, Inc.
state: Nevada
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness
state: New Jersey
city: Mount Arlington
country: United States
facility: The NeuroCognitive Institute
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience, Inc.
state: New Mexico
city: New York
country: United States
facility: Brain Resource Center
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine/Dept of Psychiaatry
state: New York
city: Durham
country: United States
facility: Duke University medical Center/ Duke ADHD Program
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine/UCPC
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Nisonger Center
state: Ohio
city: Tulsa
country: United States
facility: Tulsa Clinical Research, LLC
state: Oklahoma
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Portland
country: United States
facility: Oregon Center for Clinical Investigations Inc
state: Oregon
city: Portland
country: United States
facility: Summit Research Network
state: Oregon
city: Salem
country: United States
facility: Oregon Center for Clinical Investigations, Inc
state: Oregon
city: West Chester
country: United States
facility: University Services
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Barnwell
country: United States
facility: Rainbow Research, Inc.
state: South Carolina
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP
state: Texas
city: Dallas
country: United States
facility: Research Across America/Psychiatric Medical Associates
state: Texas
city: Houston
country: United States
facility: Bayou City Research
state: Texas
city: Houston
country: United States
facility: Claghorn-Lesem Research Clinic, Ltd.
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development, Inc.
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates, PA
state: Texas
city: Houston
country: United States
facility: Houston Clinical Trials, LLC
state: Texas
city: Lubbock
country: United States
facility: Westex Clinical Investigations
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: San Antonio
country: United States
facility: Univ of Texas Health Science Center at San Antonio
state: Texas
city: Clinton
country: United States
facility: Ericksen Research and Development - Westside Medical
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Child and Family Psychiatry Clinic
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Kirkland
country: United States
facility: Eastside Thereapeutic Resource
state: Washington
city: Seattle
country: United States
facility: Summit Research Network (Seattle), LLC
state: Washington
city: Spokane
country: United States
facility: Rockwood Clinic, P.S.
state: Washington
city: Kentville
country: Canada
facility: True North Clinical Research
state: Nova Scotia
city: Whitby
country: Canada
facility: The Kids Clinic
state: Ontario
city: Bamberg
country: Germany
facility: Schwerpunktpraxis fur Entwicklung und Lernen
city: Frankfurt
country: Germany
facility: Klinik Fur Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie
city: Freiburg
country: Germany
facility: Universitatsklinikum Freiburg
city: Hamburg
country: Germany
facility: Kinderarztpraxis Dr. Kaiser und Dr. MarineBe
city: Mannheim
country: Germany
facility: Zentralinstitut fur Seelische Gesundheit
city: Wurzburg
country: Germany
facility: Medizinisches Studienzentrum Wurzburg
city: Budapest
country: Hungary
facility: Vadaskert Gyermekpszichiatriai Korhaz es Szakambulancia
city: Gyula
country: Hungary
facility: Bekes Megyei Pandy Kalman Korhaz
city: Pecs
country: Hungary
facility: Pecsi Megyei Jogu varos Egyesitett Egeszsegugyi Intezmenyek
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem
city: Goteborg
country: Sweden
facility: Gillbergcentrum
city: Spanga
country: Sweden
facility: PRIMA Barn-och Vuxenpsykiatri Jarva
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.