Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy of SPD503 compared to placebo in the treatment of children and adolescents aged 6-17 with ADHD.

Official Title
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A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of SPD503 in Children and Adolescents Aged 6-17 With Attention Deficit Hyperactivity Disorder (ADHD)

Conditions
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Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
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* Drug: SPD503 (1 mg)
* Drug: SPD503 (2 mg)
* Drug: SPD503 (3 mg)
* Drug: SPD503 (4 mg)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with a primary diagnosis of ADHD Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements Exclusion Criteria: Subject has a current, uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as severe comorbid Axis II disorders or severe Axis I disorders Subject weighs less than 55 lbs or is morbidly overweight with a BMI => 35 Subject has a history of seizure during the last 2 years or a serious tic disorder, including Tourette's Disorder Subject is pregnant or lactating

Ages Eligible for Study
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Minimum Age: 6 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPD503 (Guanfacine HCl) (1 mg)<br> | Drug: SPD503 (1 mg)<br> <br> * Other names: Guanfacine hydrochloride;|
| Experimental: SPD503 (2 mg)<br> | Drug: SPD503 (2 mg)<br> <br> |
| Experimental: SPD503 (3 mg)<br> | Drug: SPD503 (3 mg)<br> <br> |
| Experimental: SPD503 (4 mg)<br> | Drug: SPD503 (4 mg)<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <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 (ADHD-RS-IV) Score at 6 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 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks | The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior. | Baseline and 6 weeks | 
| Number of Participants With Improvement in 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 (very much improved) or 2 (much improved) on the scale. | 6 weeks | 
| Number of Participants With Improvement in Parent 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. | 6 weeks | 
| Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 6 Weeks | The Child Health Questionnaire-Parent Form (CHQ-PF50) was developed to measure the physical and psychosocial well-being of children aged 5 years of age and older. Total scoring ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents. | Baseline and 6 weeks |