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

Phase 3

Completed

• Conditions: Attention Deficit Disorder With Hyperactivity
• Interventions: Drug: SPD503 (4 mg); Drug: Placebo; Drug: SPD503 (3 mg); Drug: SPD503 (1 mg); Drug: SPD503 (2 mg)

• Registration Number: NCT00150618
• Lead Sponsor: Shire

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03-30
• Primary Completion: 2004-10-07
• Study Completion: 2004-10-07
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Results First Submitted: 2009-09-10
• Results First Submitted QC: 2009-09-11
• Results First Posted: 2009-10-15
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-29
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 324

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPD503 (4 mg)	SPD503 (4 mg)	-
Placebo	Placebo	-
SPD503 (3 mg)	SPD503 (3 mg)	-
SPD503 (Guanfacine HCl) (1 mg)	SPD503 (1 mg)	-
SPD503 (2 mg)	SPD503 (2 mg)	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at 6 Weeks	Baseline and 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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks	Baseline and 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.
Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)	6 weeks	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.
Number of Participants With Improvement in Parent Global Assessment (PGA)	6 weeks	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.
Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 6 Weeks	Baseline and 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.