Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD

Study Overview
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Brief Summary
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Assess the efficacy & tolerability of Vyvanse when children aged 6-12 years diagnosed with ADHD are dosed to optimal effect.

Detailed Description
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Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (lisdexamfetamine dimesylate) in Children aged 6-12 Diagnosed with ADHD

Official Title
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A Prospective, Open-Label, Multi-Center, Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) 20-70mg in Children Aged 6-12 Diagnosed With ADHD

Conditions
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Attention Deficit Hyperactivity Disorder (ADHD)

Intervention / Treatment
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* Drug: Vyvanse (lisdexamfetamine dimesylate)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subject is a male or female aged 6-12 years inclusive at the time of consent. Females of Child-bearing Potential (FOCP) must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to comply with any applicable contraceptive requirements of the protocol. primary diagnosis of ADHD based on a detailed psychiatric evaluation. Subjects must have a baseline ADHD-RS-IV total score ≥28. Subject is functioning at an age-appropriate level intellectually. comply with all the testing and requirements. Subject is able to swallow a capsule. Subject has blood pressure measurements within the 95th percentile for age, gender, and height. Exclusion Criteria Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as Post Traumatic Stress Disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder or other symptomatic manifestations. Subject has Conduct Disorder. Subject has a documented allergy, hypersensitivity, or intolerance to amphetamines. Subject has failed to respond to one or more adequate courses (dose and duration) of amphetamine therapy. The subject has a recent history (within the past 6 months) of suspected substance abuse or dependence. Subject has a positive urine drug result. Subject weighs less than 50 pounds (22.7kg). Subject is significantly overweight. Subject has a history of seizures (exclusive of febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder. Subject has any reported history of abnormal thyroid function. Subject has taken another investigational product or taken part in a clinical trial within 30 days prior to Screening. Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments. The female subject is pregnant or lactating. Subject is well-controlled on their current ADHD medication with acceptable tolerability.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Vyvanse (lisdexamfetamine dimesylate)<br>* Vyvanse™ 20mg once daily at 7 a.m.; dose increased weekly by 10mg until an acceptable response is achieved. Titration may proceed to a maximum daily dose 70mg/day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Total Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Score at 7 Weeks | Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. 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. | Baseline and 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weekly Change From Baseline in Total ADHD-RS-IV Score | Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. 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. | Baseline and 1, 2, 3, 4, 5, 6, and 7 weeks | 
| Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) | 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 or 2 on the scale. | 7 weeks | 
| Number of Participants With Improvement onParent Global Assessment (PGA) | Parent Global Assessment (PGA) 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. | 7 weeks | 
| Change From Baseline in Expression and Emotional Scale for Children (EESC) Scores at 7 Weeks | Expression and Emotional Scale for Children (EESC) consists of 29 items rated on a scale from 1 (not true at all) to 5 (very much true). Lower scores reflect better emotional outcomes. | Baseline and 7 weeks | 
| Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at 7 Weeks | Behavior Rating Inventory of Executive Function (BRIEF) is an 86-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Lower scores reflect better functioning. | Baseline and 7 weeks |