Clinical trial NCT01552915: 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, 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)
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: 464
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 8
timeFrame: Baseline and week 8
Secondary outcomes:
measure: Percentage of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 8 - Last Observation Carried Forward (LOCF)
timeFrame: Week 8
measure: Change From Baseline in Systolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment
timeFrame: Baseline and up to 8 Weeks
measure: Change From Baseline in Diastolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment
timeFrame: Baseline and up to 8 weeks
measure: Change From Baseline in Pulse Rate at up to 8 Weeks - Last on Treatment Assessment
timeFrame: Baseline and up to 8 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Melmed Center
state: Arizona
city: Little Rock
country: United States
facility: Clinical Study Centers, LLC
state: Arkansas
city: National City
country: United States
facility: Synergy Clinical Research Center
state: California
city: Orange
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Orange
country: United States
facility: SDS Clinical Trials, Inc.
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates, Inc.
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: Santa Ana
country: United States
facility: Neuropsychiatric Research Center of Orange County
state: California
city: Wildomar
country: United States
facility: Elite Clinical Trials
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers, LLC
state: Colorado
city: Bradenton
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: Amedica Research Institute
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Lauderhill
country: United States
facility: Fidelity Clinical Research, Inc.
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Miami
country: United States
facility: Scientific Clinical Research, Inc.
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: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: West Palm Beach
country: United States
facility: Janus Center for Psychiatric Research
state: Florida
city: Atlanta
country: United States
facility: Atlanta Institute of Medicine and Research
state: Georgia
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Naperville
country: United States
facility: AMR Baber Research Group, Inc.
state: Illinois
city: Naperville
country: United States
facility: AMR Conventions Research
state: Illinois
city: Oak Brook
country: United States
facility: American Medical Research, Inc
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Hope Children's Hospital
state: Illinois
city: Oak Park
country: United States
facility: Neuroscience Research Institute, Inc
state: Illinois
city: Overland Park
country: United States
facility: Psychiatric Associates
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Paducah
country: United States
facility: Four Rivers Clinical Research
state: Kentucky
city: Rockville
country: United States
facility: Neuroscientific InSights
state: Maryland
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: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Gladstone
country: United States
facility: Comprehensive Psychiatric Associates
state: Missouri
city: Saint Charles
country: United States
facility: St Charles Psychiatric Associates
state: Missouri
city: Lincoln
country: United States
facility: Premier Psychiatric Research Institute
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioral Medicine, Inc.
state: Nevada
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness
state: New Jersey
city: Gibbsboro
country: United States
facility: CRCNJ - Clinical Research Center of New Jersey
state: New Jersey
city: Mount Arlington
country: United States
facility: Neurcognitive Institute
state: New Jersey
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Durham
country: United States
facility: Duke Child and Family Study Center
state: North Carolina
city: Fargo
country: United States
facility: Innovis Health, LLC
state: North Dakota
city: Beachwood
country: United States
facility: North Coast Clinical Trials
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Dept. of Psychiatry & Behavioral
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Nisonger Center
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Mason
country: United States
facility: Professional Psychiatric Services
state: Ohio
city: Wadsworth
country: United States
facility: Family Practice of Wadsworth, Inc.
state: Ohio
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Portland
country: United States
facility: Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
state: Oregon
city: Portland
country: United States
facility: Summit Research Network (Oregon) Inc.
state: Oregon
city: Salem
country: United States
facility: Oregon Center for Clinical Investigations, Inc.
state: Oregon
city: Charleston
country: United States
facility: Carolina Clinical Trials, Inc.
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Memphis
country: United States
facility: Research Strategies of Memphis, LLC
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: Houston
country: United States
facility: Claghorn-Lesem Reseach Clinic, Ltd.
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: Lake Jackson
country: United States
facility: R/D Clinical Research, Inc.
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: University of Texas HSC at San Antonio Dept. of Psychiatry
state: Texas
city: Wharton
country: United States
facility: Wharton Research Center, Inc.
state: Texas
city: Salt Lake City
country: United States
facility: Psychiatric & Behavioral Solutions
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Child and Family Psychiatry Clinical
state: Virginia
city: Herndon
country: United States
facility: NeuroScience, Inc.
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Kirkland
country: United States
facility: Eastside Therapeutic 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
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.