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

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

Official Title
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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)

Conditions
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Attention-deficit/Hyperactivity Disorder

Intervention / Treatment
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* Drug: Lisdexamfetamine dimesylate
* Drug: Methylphenidate Hydrochloride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lisdexamfetamine Dimesylate<br> | Drug: Lisdexamfetamine dimesylate<br>* Daily oral dosing in the AM of optimized dose, ranging from 30- 70 mg. 5 week dose optimization, 3 week dose maintenance<br>* Other names: LDX, Vyvanse, SPD489;|
| Active Comparator: Methylphenidate Hydrochloride<br> | Drug: Methylphenidate Hydrochloride<br>* Daily oral dosing in the AM of optimized dose, ranging from 18-72 mg. 5 week dose optimization, 3 week dose maintenance<br>* Other names: OROS-MPH, Concerta;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Daily oral dosing in the AM for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change From Baseline in Systolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment |  | Baseline and up to 8 Weeks | 
| Change From Baseline in Diastolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment |  | Baseline and up to 8 weeks | 
| Change From Baseline in Pulse Rate at up to 8 Weeks - Last on Treatment Assessment |  | Baseline and up to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD