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

Shire

Status and phase: Completed; Phase 2

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Drug: Placebo; Drug: SPD503 (Guanfacine HCl)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00150592

SPD503-206

Details and patient eligibility

About

The purpose of this study is to determine the effects of SPD503 compared to placebo on tasks of sustained attention in children and adolescents aged 6-17 diagnosed with ADHD.

Enrollment: 182 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with a primary diagnosis of ADHD
• Minimum baseline visit ADHD-RS-IV score of 24 and a baseline CGI-S score =>4
• Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements
• Subject weighs > 55 lbs and is not morbidly overweight

Exclusion criteria

• Subject has a comorbid psychiatric diagnosis (except ODD) with significant symptoms such as any severe comorbid Axis II disorders or severe Axis I disorders
• Subject has a history of seizure disorder
• Subject has any specific cardiac condition or family history of significant cardiac condition
• Subject is pregnant, lactating or within six month post-partum

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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182 participants in 2 patient groups, including a placebo group

SPD503 (Guanfacine HCl)

Experimental group

Treatment:

Drug: SPD503 (Guanfacine HCl)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo