Phase 3
Completed N=345
Safety and Efficacy of SPD503 in Treating Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-17
Attention Deficit Disorder With Hyperactivity
Source: ClinicalTrials.gov NCT00152009 ↗
Enrolled (actual)
345
Serious AEs
0.6%
Results posted
Nov 2009
Primary outcomePrimary: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at Up to 5 Weeks — -15.93; -16.03; -18.51; -8.51 Units on a Scale — p=0.0006
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at Up to 5 Weeks |
-15.93; -16.03; -18.51; -8.51 | 0.0006 sig |
| SECONDARY Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at Up to 5 Weeks |
-15.59; -15.43; -21.49; -8.66 | 0.025 sig |
| SECONDARY Change From Baseline in Conner's Teacher Rating Scale-revised Short Version (CTRS-R) Score at Up to 5 Weeks |
-13.02; -14.88; -15.26; -2.17 | <0.0001 sig |
| SECONDARY Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) |
47; 41; 45; 20 | <0.0001 sig |
| SECONDARY Number of Participants With Improvement in Parent Global Assessment (PGA) |
41; 31; 39; 15 | <0.0001 sig |
| SECONDARY Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 5 Weeks |
9.03; 9.01; 10.64; 5.72; 0.24; -1.82 | 0.1438 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00152009). 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.