Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study)
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Interventions
- Registration Number
- NCT00997984
- Lead Sponsor
- Shire
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 340
- 6-12 years old
- ADHD diagnosis
- ADHD-RS-IV minimum score of 28
- CGI-S score > or = 4
- Current, controlled or uncontrolled, comorbid psychiatric diagnosis
- Condition or illness which represent inappropriate risk to subject
- Known history or presence of structural cardiac abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction problems, exercise-related cardiac events, or clinically significant bradycardia; orthostatic hypotension or controlled or uncontrolled hypertension
- Use of prohibited medication that have CNS effects or affect cognitive performance
- History of alcohol or substance abuse within 6 months
- Current use of medication that affect BP or heart rate
- Significantly overweight
- Weight of less than 55 lbs
- Known allergy to SPD503
- Abnormal urine drug and alcohol screen
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Extended-release Guanfacine Hydrochloride (SPD503) AM extended-release guanfacine hydrochloride (SPD503) - placebo placebo - SPD503 PM extended-release guanfacine hydrochloride -
- Primary Outcome Measures
Name Time Method Change From Baseline in Attention-Deficit/Hyperactivity Disorder-Rating Scale-IV (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF) Baseline and up to 8 weeks 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.
- Secondary Outcome Measures
Name Time Method Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF Baseline and up to 8 weeks 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)
Improvement on Clinical Global Impression-Improvement (CGI-I) Scale at Week 8 - LOCF up to 8 weeks 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.
Change From Baseline in Conner's Parent Rating Scale - Revised Short Version (CPRS-R:S) Score at Week 8 - LOCF Baseline and up to 8 weeks 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.
Change From Baseline in Mean Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Week 8 - LOCF Baseline and up to 8 weeks 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.
Change From Baseline in Systolic Blood Pressure at Week 8 - LOCF Baseline and up to 8 weeks Change From Baseline in Diastolic Blood Pressure at Week 8 - LOCF Baseline and up to 8 weeks Change From Baseline in Pulse Rate at Week 8 - LOCF Baseline and up to 8 weeks Change From Baseline in Height at Week 8 - LOCF Baseline and up to 8 weeks Change From Baseline in Weight at Week 8 - LOCF Baseline and up to 8 weeks Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 8 - LOCF Baseline and up to 8 weeks 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.
Change From Baseline in Health Utilities Index-2/3 (HUI 2/3) Scores at Week 8 - LOCF Baseline and up to 8 weeks 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.
Change From Baseline in the Bedtime Resistance Subscale of Child's Sleep Habits Questionnaire (CSHQ) at Week 8 - LOCF Baseline and up to 8 weeks 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.
Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF up to 8 weeks 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.
Change From Baseline in Oral Temperature at Week 8 - LOCF Baseline and up to 8 weeks
Trial Locations
- Locations (43)
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
🇺🇸Maitland, Florida, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Memphis, Tennessee, United States
Janus Centerfor Psychiatric Research
🇺🇸West Palm Beach, Florida, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Scroll for more (33 remaining)Clinical Study Centers, LLC🇺🇸Little Rock, Arkansas, United States