Phase 3
Completed N=461
Efficacy and Safety of SPD503 in Combination With Psychostimulants
Source: ClinicalTrials.gov NCT00734578 ↗Enrolled (actual)
461
Serious AEs
0.7%
Results posted
Nov 2010
Primary outcomePrimary: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF) — -20.4; -21.0; -16.0 Units on a scale — p=0.002
Summary
The purpose of this study is to assess the efficacy and safety of SPD503 in subjects with ADHD when co-administered with psychostimulants in children and adolescents aged 6-17 years with a diagnosis of ADHD with a sub-optimal, partial response to stimulants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF) |
-20.4; -21.0; -16.0 | 0.002 sig |
| SECONDARY Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 8 - LOCF |
70.5; 74.3; 57.9 | 0.024 sig |
| SECONDARY Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF |
22.8; 25.0; 15.1; 19.5; 26.4; 17.8 | 0.013 sig |
| SECONDARY Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Morning Assessment (Before School) |
-8.4; -9.6; -6.9 | 0.019 sig |
| SECONDARY Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Evening Assessment (Before Bedtime) |
-8.2; -8.8; -6.0 | 0.002 sig |
| SECONDARY Percentage of Participants With Improvement on Parent Global Assessment (PGA) at Week 8 - LOCF |
69.8; 67.7; 47.5 | <0.001 sig |
| SECONDARY Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Week 8 - LOCF |
-6.6; -6.3; -4.2 | 0.001 sig |
| SECONDARY Change From Baseline in Before School Functioning Questionnaire (BSFQ) at Week 8 - LOCF |
-16.7; -16.7; -11.5 | <0.001 sig |
| SECONDARY Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF |
0.7; 0.7; 0.0; 6.7; 6.8; 3.3 | 0.971 |
Eligibility Criteria
Inclusion Criteria
- Healthy subjects with ADHD currently taking a stable dose of psychostimulant for at least 4 weeks
- Aged 6-17 years with a sub-optimal
- Partial response to stimulants
- Subjects must be = 55lbs and <= 176lbs
Data sourced from ClinicalTrials.gov (NCT00734578). 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.