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, 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552915
• Other study ID #: SPD489-405
• Status: Completed
• Phase: Phase 4
• Start date: April 17, 2012
• Est. completion date: January 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: 464
• Est. completion date: January 22, 2014
• Est. primary completion date: January 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 of optimized dose, ranging from 30- 70 mg. 5 week dose optimization, 3 week dose maintenance
• Methylphenidate Hydrochloride
Daily oral dosing in the AM of optimized dose, ranging from 18-72 mg. 5 week dose optimization, 3 week dose maintenance
• Placebo
Daily oral dosing in the AM for 8 weeks

Locations

Country	Name	City	State
United States	Atlanta Institute of Medicine and Research	Atlanta	Georgia
United States	FutureSearch Trials	Austin	Texas
United States	North Coast Clinical Trials	Beachwood	Ohio
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Florida Clinical Research Center, LLC	Bradenton	Florida
United States	Carolina Clinical Trials, Inc.	Charleston	South Carolina
United States	University of Virginia Child and Family Psychiatry Clinical	Charlottesville	Virginia
United States	Center for Emotional Fitness	Cherry Hill	New Jersey
United States	University of Cincinnati Dept. of Psychiatry & Behavioral	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	MCB Clinical Research Centers, LLC	Colorado Springs	Colorado
United States	The Ohio State University Nisonger Center	Columbus	Ohio
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Duke Child and Family Study Center	Durham	North Carolina
United States	Innovis Health, LLC	Fargo	North Dakota
United States	Precise Research Centers	Flowood	Mississippi
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	CRCNJ - Clinical Research Center of New Jersey	Gibbsboro	New Jersey
United States	Comprehensive Psychiatric Associates	Gladstone	Missouri
United States	Cyn3rgy Research	Gresham	Oregon
United States	NeuroScience, Inc.	Herndon	Virginia
United States	Amedica Research Institute	Hialeah	Florida
United States	Claghorn-Lesem Reseach Clinic, Ltd.	Houston	Texas
United States	Red Oak Psychiatry Associates, PA	Houston	Texas
United States	Texas Center for Drug Development, Inc.	Houston	Texas
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Eastside Therapeutic Resource	Kirkland	Washington
United States	R/D Clinical Research, Inc.	Lake Jackson	Texas
United States	Center for Psychiatry and Behavioral Medicine, Inc.	Las Vegas	Nevada
United States	Fidelity Clinical Research, Inc.	Lauderhill	Florida
United States	University of Kentucky	Lexington	Kentucky
United States	Capstone Clinical Research	Libertyville	Illinois
United States	Premier Psychiatric Research Institute	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	Professional Psychiatric Services	Mason	Ohio
United States	Research Strategies of Memphis, LLC	Memphis	Tennessee
United States	Scientific Clinical Research, Inc.	Miami	Florida
United States	Neurcognitive Institute	Mount Arlington	New Jersey
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	AMR Baber Research Group, Inc.	Naperville	Illinois
United States	AMR Conventions Research	Naperville	Illinois
United States	Synergy Clinical Research Center	National City	California
United States	Mount Sinai School of Medicine	New York	New York
United States	American Medical Research, Inc	Oak Brook	Illinois
United States	Advocate Hope Children's Hospital	Oak Lawn	Illinois
United States	Neuroscience Research Institute, Inc	Oak Park	Illinois
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Pacific Clinical Research Medical Group	Orange	California
United States	SDS Clinical Trials, Inc.	Orange	California
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Compass Research, LLC	Orlando	Florida
United States	Psychiatric Associates	Overland Park	Kansas
United States	Four Rivers Clinical Research	Paducah	Kentucky
United States	Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)	Portland	Oregon
United States	Summit Research Network (Oregon) Inc.	Portland	Oregon
United States	Rochester Center for Behavioral Medicine	Rochester Hills	Michigan
United States	Marc Hertzman MD, PC	Rockville	Maryland
United States	Neuroscientific InSights	Rockville	Maryland
United States	Peninsula Research Associates, Inc.	Rolling Hills Estates	California
United States	St Charles Psychiatric Associates	Saint Charles	Missouri
United States	Oregon Center for Clinical Investigations, Inc.	Salem	Oregon
United States	Psychiatric & Behavioral Solutions	Salt Lake City	Utah
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	University of Texas HSC at San Antonio Dept. of Psychiatry	San Antonio	Texas
United States	PCSD - Feighner Research	San Diego	California
United States	University of California, San Francisco	San Francisco	California
United States	Neuropsychiatric Research Center of Orange County	Santa Ana	California
United States	Melmed Center	Scottsdale	Arizona
United States	Summit Research Network (Seattle), LLC	Seattle	Washington
United States	Rockwood Clinic, P.S.	Spokane	Washington
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	Family Practice of Wadsworth, Inc.	Wadsworth	Ohio
United States	Janus Center for Psychiatric Research	West Palm Beach	Florida
United States	Wharton Research Center, Inc.	Wharton	Texas
United States	Elite Clinical Trials	Wildomar	California

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change From Baseline in Systolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment		Baseline and up to 8 Weeks
Secondary	Change From Baseline in Diastolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment		Baseline and up to 8 weeks
Secondary	Change From Baseline in Pulse Rate at up to 8 Weeks - Last on Treatment Assessment		Baseline and up to 8 weeks