The primary purpose is to assess the efficacy of once daily dosing with optimized SPD503 (1, 2, 3 and 4mg/day), dosed either in the morning or evening, compared to placebo, in children with ADHD as measured by change from baseline score at endpoint on the ADHD-RS-IV.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
340
Change From Baseline in Attention-Deficit/Hyperactivity Disorder-Rating Scale-IV (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
Time frame: Baseline and up to 8 weeks
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Time frame: Baseline and up to 8 weeks
Improvement on Clinical Global Impression-Improvement (CGI-I) Scale at Week 8 - LOCF
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.
Time frame: up to 8 weeks
Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 8 - LOCF
The Pediatric Daytime Sleepiness Scale (PDSS) is an 8 question questionnaire scored on a scale from 0 (never) to 4 (always). Total scores range from 0 to 32, with increasing score reflecting greater sleepiness.
Time frame: Baseline and up to 8 weeks
Change From Baseline in Health Utilities Index-2/3 (HUI 2/3) Scores at Week 8 - LOCF
HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.
Time frame: Baseline and up to 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clinical Study Centers, LLC
Little Rock, Arkansas, United States
Valley Clinical Research, Inc.
El Centro, California, United States
Peninsula Research Associates, Inc.
Rolling Hills Estates, California, United States
Psychiatric centers at San Diego, Feighner Research
San Diego, California, United States
Elite Clinical Trials, Inc.
Wildomar, California, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Florida Clinical Research Center, LLC
Maitland, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
...and 36 more locations
Change From Baseline in Conner's Parent Rating Scale - Revised Short Version (CPRS-R:S) Score at Week 8 - LOCF
The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.
Time frame: Baseline and up to 8 weeks
Change From Baseline in the Bedtime Resistance Subscale of Child's Sleep Habits Questionnaire (CSHQ) at Week 8 - LOCF
The bedtime resistance subscale of CSHQ consists of 6 items scored on a scale from 1 (never/rarely) to 3 (Usually). A higher score reflects more disturbed sleep behavior.
Time frame: Baseline and up to 8 weeks
Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF
Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.
Time frame: up to 8 weeks
Change From Baseline in Mean Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Week 8 - LOCF
The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Mean scores range from 0 to 3.
Time frame: Baseline and up to 8 weeks
Change From Baseline in Systolic Blood Pressure at Week 8 - LOCF
Time frame: Baseline and up to 8 weeks
Change From Baseline in Diastolic Blood Pressure at Week 8 - LOCF
Time frame: Baseline and up to 8 weeks
Change From Baseline in Pulse Rate at Week 8 - LOCF
Time frame: Baseline and up to 8 weeks
Change From Baseline in Oral Temperature at Week 8 - LOCF
Time frame: Baseline and up to 8 weeks
Change From Baseline in Height at Week 8 - LOCF
Time frame: Baseline and up to 8 weeks
Change From Baseline in Weight at Week 8 - LOCF
Time frame: Baseline and up to 8 weeks