At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 75 enrolled
Drug / intervention
Methylphenidate + SPD503 (Guanfacine hydrochloride) +1 moredrug
Likely dose
Methylphenidate or amphetamine (dose not specified) + SPD503 (guanfacine hydrochloride) (dose not specified)AI-extracted
Key inclusion· 4
- ✓Primary diagnosis of ADHD
- ✓On stable dose of approved ADHD psychostimulant for at least 1 month with sub-optimal control
- ✓Aged 6-17 years
- ✓Male or non-pregnant female
Key exclusion· 4
- ✕Current uncontrolled comorbid psychiatric diagnosis (except ODD and mild anxiety)
- ✕History of seizure in the last 2 years
- ✕Specific cardiac condition or family history of significant cardiac condition
- ✕Pregnancy or lactation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Open-Label Co-Administration Study of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
In Brief
A Phase 2 clinical trial evaluating Methylphenidate + SPD503 (Guanfacine hydrochloride) and Amphetamine + SPD503 for Attention Deficit Disorder With Hyperactivity. Completed, enrolled 75 participants.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2004
Primary CompletionDec 2004
First PostedSep 2005
TodayJul 2026
First PostedSep 9, 2005
Enrollment StartAug 16, 2004
Primary CompletionDec 27, 2004
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 20.8 years ago
Interventions
Methylphenidate + SPD503 (Guanfacine hydrochloride)drug
Amphetamine + SPD503drug