Phase 2
Completed N=178
Safety, Tolerability and Efficacy of SPD503 in Treating ADHD in Children Aged 6-17
Attention Deficit Disorder With Hyperactivity
Source: ClinicalTrials.gov NCT00150592 ↗
Enrolled (actual)
178
Serious AEs
1.1%
Results posted
Oct 2009
Primary outcomePrimary: Change From Baseline in Choice Reaction Time (CRT) at 6 Weeks — 20.7; 21.9 msec — p=0.844
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Choice Reaction Time (CRT) at 6 Weeks |
20.7; 21.9 | 0.844 |
| SECONDARY Change From Baseline in Digital Symbol Substitution Task/Coding Test (DSST/Coding) Scores at 6 Weeks in Age Category 8-17 Years |
18.3; 20.7 | 0.274 |
| SECONDARY Change From Baseline in DSST/Coding Scores at 6 Weeks in Age Category 6-7 Years |
1.9; 9.7 | — |
| SECONDARY Change From Baseline in Spatial Working Memory (SWM) Scores at 6 Weeks |
-4.4; -3.2; 0.0; -0.1; -0.0; 0.1 | 0.307 |
| SECONDARY Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks |
-8.8; -5.5 | 0.001 sig |
| SECONDARY Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) at 6 Weeks |
67; 20 | 0.007 sig |
| SECONDARY Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Scores at 6 Weeks |
-1.3; 0.9 | 0.02 sig |
| SECONDARY Change From Baseline in Pictorial Sleepiness Scale (PSS) Scores at 6 Weeks |
0.0; 0.1 | 0.231 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00150592). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.