Phase 3
Completed N=324
Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17
Attention Deficit Disorder With Hyperactivity
Source: ClinicalTrials.gov NCT00150618 ↗
Enrolled (actual)
324
Serious AEs
0.6%
Results posted
Oct 2009
Primary outcomePrimary: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at 6 Weeks — -19.44; -18.09; -20.00; -20.57 Units on a Scale — p=0.0041
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at 6 Weeks |
-19.44; -18.09; -20.00; -20.57; -12.69 | 0.0041 sig |
| SECONDARY Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks |
-19.50; -14.96; -17.94; -15.93; -8.41 | 0.0010 sig |
| SECONDARY Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) |
31; 27; 33; 35; 19 | 0.0074 sig |
| SECONDARY Number of Participants With Improvement in Parent Global Assessment (PGA) |
27; 20; 29; 30; 16 | 0.0303 sig |
| SECONDARY Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 6 Weeks |
0.32; 0.35; -0.91; -2.44; -0.01; 10.61 | 0.0383 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00150618). 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.