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

Attention-deficit/Hyperactivity Disorder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552902
• Other study ID #: SPD489-406
• Secondary ID: 2011-005452-34
• Status: Completed
• Phase: Phase 4
• Start date: April 3, 2012
• Est. completion date: May 22, 2014

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 549
• Est. completion date: May 22, 2014
• Est. primary completion date: May 22, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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 (ß-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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-deficit/Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Lisdexamfetamine dimesylate
Daily oral dosing in the AM ranging from 30- 70 mg. 4 week forced dose titration, 2 week dose maintenance
• Methylphenidate Hydrochloride
Daily oral dosing in the AM ranging from 18-72 mg. 4 week force dose titration, 2 week dose maintenance
• Placebo
Daily oral dosing in the AM for 6 weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Hungary,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered as a pharmaceutical product that did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events between first dose of double-blind investigational product and up to 3 days after last dose that were absent before treatment or that worsened relative to pretreatment state.	Baseline up to 3 days after last dose (last dose at Week 6)
Other	Change From Baseline in Blood Pressure at Week 6		Baseline, Week 6
Other	Change From Baseline in Pulse Rate at Week 6		Baseline, Week 6
Primary	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.	Baseline, Week 6
Secondary	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.	Week 6