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 Clinical Trial

Official title:

A Phase 3, Double-blind, Randomized, Multicenter, Placebo-controlled, Dose Optimization Study Evaluating the Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children Aged 6-12 With a Diagnosis of Attention-Deficit/Hyperactivity Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997984
• Other study ID #: SPD503-314
• Status: Completed
• Phase: Phase 3
• Start date: November 17, 2009
• Est. completion date: October 9, 2010

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: October 9, 2010
• Est. primary completion date: October 9, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit/Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• extended-release guanfacine hydrochloride (SPD503)
dosed in AM
• placebo
dosed in the AM or PM
• extended-release guanfacine hydrochloride
Dosed in the PM

Locations

Country	Name	City	State
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	Toronto ADHD Clinic	Toronto	Ontario
Canada	BC Women;s Hospital and Health Centre	Vancouver	British Columbia
Canada	ADHD Clinical/ The Kids Clinic	Whitby	Ontario
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	FutureSearch Clinical Trials	Austin	Texas
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Mountain West Clinical Trials	Boise	Idaho
United States	Florida Clinical Research Center, LLC	Bradenton	Florida
United States	Vermont Clinical Study Center	Burlington	Vermont
United States	University of Illinois Chicago	Chicago	Illinois
United States	Valley Clinical Research, Inc.	El Centro	California
United States	Innovis Health	Fargo	North Dakota
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	NeuroScience Inc	Herndon	Virginia
United States	Claghorn-Lesem research Clinic	Houston	Texas
United States	Goldpoint Clinical Research, LLC	Indianapolis	Indiana
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	R/D Clinical Research, Inc.	Lake Jackson	Texas
United States	Center for Psychiatry and Behavioral Medicine, Inc.	Las Vegas	Nevada
United States	Clinical Study Centers, LLC	Little Rock	Arkansas
United States	Western Clinical Investigations	Lubbock	Texas
United States	Florida Clinical Research Center, LLC	Maitland	Florida
United States	Northwest Clincial Research Group	Marietta	Georgia
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	Louisiana Research Associates, Inc.	New Orleans	Louisiana
United States	American Medical research, Inc.	Oak Brook	Illinois
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Psychiatric Associates	Overland Park	Kansas
United States	Vince and Associates Clinical Research	Overland Park	Kansas
United States	Four Rivers Clinical Research, Inc.	Paducah	Kentucky
United States	CRI Worldwide, LLC	Philadelphia	Pennsylvania
United States	Western Psychiatric Institute and Clinic	Pittsburgh	Pennsylvania
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Alliance Research Group, LLC	Richmond	Virginia
United States	Richester Center for Behavioral Medicine	Rochester Hills	Michigan
United States	Marc Hertzman, M.D., P.C.	Rockville	Maryland
United States	Peninsula Research Associates, Inc.	Rolling Hills Estates	California
United States	Midwest research Group	Saint Charles	Missouri
United States	Cerebral Research, LLC	San Antonio	Texas
United States	Psychiatric centers at San Diego, Feighner Research	San Diego	California
United States	Clinco	Terre Haute	Indiana
United States	Children's Specialized Hospital	Toms River	New Jersey
United States	Janus Centerfor Psychiatric Research	West Palm Beach	Florida
United States	Elite Clinical Trials, Inc.	Wildomar	California

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Newcorn JH, Stein MA, Childress AC, Youcha S, White C, Enright G, Rubin J. Randomized, double-blind trial of guanfacine extended release in children with attention-deficit/hyperactivity disorder: morning or evening administration. J Am Acad Child Adolesc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	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.	Baseline and up to 8 weeks
Secondary	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)	Baseline and up to 8 weeks
Secondary	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.	up to 8 weeks
Secondary	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.	Baseline and up to 8 weeks
Secondary	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.	Baseline and up to 8 weeks
Secondary	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.	Baseline and up to 8 weeks
Secondary	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.	Baseline and up to 8 weeks
Secondary	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.	up to 8 weeks
Secondary	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.	Baseline and up to 8 weeks
Secondary	Change From Baseline in Systolic Blood Pressure at Week 8 - LOCF		Baseline and up to 8 weeks
Secondary	Change From Baseline in Diastolic Blood Pressure at Week 8 - LOCF		Baseline and up to 8 weeks
Secondary	Change From Baseline in Pulse Rate at Week 8 - LOCF		Baseline and up to 8 weeks
Secondary	Change From Baseline in Oral Temperature at Week 8 - LOCF		Baseline and up to 8 weeks
Secondary	Change From Baseline in Height at Week 8 - LOCF		Baseline and up to 8 weeks
Secondary	Change From Baseline in Weight at Week 8 - LOCF		Baseline and up to 8 weeks