Safety and Efficacy of SPD503 in Treating Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-17

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and efficacy of SPD503 (Guanfacine hydrochloride) compared to placebo in the treatment of ADHD in children and adolescents aged 6-17

Official Title
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A Phase III, Randomized, Multi-Center, Double-Blind, 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 (Guanfacine hydrochloride) (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 Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements Exclusion Criteria: Subject has current uncontrolled comorbid psychiatric diagnosis (except ODD) with significant symptoms History of seizure during the last 2 years Subject has any specific cardiac condition or family history of significant cardiac condition 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) (2 mg)<br> | Drug: SPD503 (Guanfacine hydrochloride) (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 Up to 5 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 up to 5 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 Up to 5 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) reflecting no symptoms to 3 (very much true) reflecting severe symptoms 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 up to 5 weeks | 
| Change From Baseline in Conner's Teacher Rating Scale-revised Short Version (CTRS-R) Score at Up to 5 Weeks | The Conner's Teacher Rating Scale-revised short version (CTRS-R) consists of 28 questions graded on a scale from 0 (not true at all) reflecting no symptoms to 3 (very much true) reflecting severe symptoms with a total score ranging from 0 to 84. Higher scores are indicative of increased ADHD. This scale allows teachers to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior. | Baseline and up to 5 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. | up to 5 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. | up to 5 weeks | 
| Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 5 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 score ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents. | Baseline and 5 weeks |