Phase 3 Completed N=340 Randomized Quadruple-blind Treatment

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)

Attention Deficit Hyperactivity Disorder

Source: ClinicalTrials.gov NCT00997984 ↗

Enrolled (actual)

340

Serious AEs

1.1%

Results posted

Oct 2011

Primary outcomePrimary: Change From Baseline in Attention-Deficit/Hyperactivity Disorder-Rating Scale-IV (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF) — -10.6; -20.0; -20.4; -20.2 Units on a scale — p=<0.001

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Attention-Deficit/Hyperactivity Disorder-Rating Scale-IV (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)	-10.6; -20.0; -20.4; -20.2	<0.001 sig
SECONDARY Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF	4.5; 11.5; 16.1; 13.9; 8.2; 20.2	<0.001 sig
SECONDARY Improvement on Clinical Global Impression-Improvement (CGI-I) Scale at Week 8 - LOCF	31.8; 66.3; 67.0; 66.7	<0.001 sig
SECONDARY Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 8 - LOCF	-3.1; -2.7; -1.4; -2.0	0.099
SECONDARY Change From Baseline in Health Utilities Index-2/3 (HUI 2/3) Scores at Week 8 - LOCF	0.043; 0.056; 0.063; 0.060	—
SECONDARY Change From Baseline in Conner's Parent Rating Scale - Revised Short Version (CPRS-R:S) Score at Week 8 - LOCF	-10.4; -22.9; -21.2; -22.0	<0.001 sig
SECONDARY Change From Baseline in the Bedtime Resistance Subscale of Child's Sleep Habits Questionnaire (CSHQ) at Week 8 - LOCF	-0.7; -0.5; -1.0; -0.8	0.712
SECONDARY Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF	2.7; 1.0; 0.0; 0.5; 6.4; 5.8	0.859
SECONDARY Change From Baseline in Mean Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Week 8 - LOCF	-0.20; -0.35; -0.37; -0.36	<0.001 sig
SECONDARY Change From Baseline in Systolic Blood Pressure at Week 8 - LOCF	-0.5; -1.6; -2.1; -1.9; -1.4; -3.3	—
SECONDARY Change From Baseline in Diastolic Blood Pressure at Week 8 - LOCF	-0.3; -0.8; -2.1; -1.5; 0.2; -2.2	—
SECONDARY Change From Baseline in Pulse Rate at Week 8 - LOCF	1.0; -3.7; -3.8; -3.8; 0.9; -1.9	—
SECONDARY Change From Baseline in Oral Temperature at Week 8 - LOCF	0.06; -0.12; -0.09; -0.10	—
SECONDARY Change From Baseline in Height at Week 8 - LOCF	0.28; 0.39; 0.43; 0.41	—
SECONDARY Change From Baseline in Weight at Week 8 - LOCF	2.15; 2.37; 2.64; 2.50	—

Eligibility Criteria

Inclusion Criteria

6-12 years old
ADHD diagnosis
ADHD-RS-IV minimum score of 28
CGI-S score > or = 4

Exclusion Criteria

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

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Data sourced from ClinicalTrials.gov (NCT00997984). 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.