Phase 2
Completed N=75
Safety and Tolerability of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Attention Deficit Disorder With Hyperactivity
Source: ClinicalTrials.gov NCT00151996 ↗
Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Nov 2009
Primary outcomePrimary: Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks — -17.8; -13.8 Units on a Scale — p=<0.0001
Summary
The purpose of this study is to assess the safety and tolerability of administering SPD503 (Guanfacine hydrochloride) with psychostimulants (amphetamine or methylphenidate) for treatment of ADHD in children and adolescents aged 6-17
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks |
-17.8; -13.8 | <0.0001 sig |
| SECONDARY Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores |
28; 18 | — |
| SECONDARY Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Total Score at 6 Weeks |
-22.18; -16.28 | <0.0001 sig |
| SECONDARY Number of Participants With Improvement on Parent Global Assessment (PGA) Scores |
32; 21 | — |
| SECONDARY Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Scores at 6 Weeks |
-0.38; 0.22; 8.98; 11.56 | 0.7004 |
Eligibility Criteria
Inclusion Criteria
- Subjects with a primary diagnosis of ADHD
- Subject on a stable dose of a psychostimulant approved for the treatment of ADHD for at least 1 month, with sub-optimal control in the Investigator's opinion
- 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 and mild anxiety) 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 (NCT00151996). 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.