Clinical trial NCT00997984: 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)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention-Deficit/Hyperactivity Disorder
Keywords: ADHD
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2009-10-20
Enrollment: 340
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Attention-Deficit/Hyperactivity Disorder-Rating Scale-IV (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)
timeFrame: Baseline and up to 8 weeks
Secondary outcomes:
measure: Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF
timeFrame: Baseline and up to 8 weeks
measure: Improvement on Clinical Global Impression-Improvement (CGI-I) Scale at Week 8 - LOCF
timeFrame: up to 8 weeks
measure: Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 8 - LOCF
timeFrame: Baseline and up to 8 weeks
measure: Change From Baseline in Health Utilities Index-2/3 (HUI 2/3) Scores at Week 8 - LOCF
timeFrame: Baseline and up to 8 weeks
measure: Change From Baseline in Conner's Parent Rating Scale - Revised Short Version (CPRS-R:S) Score at Week 8 - LOCF
timeFrame: Baseline and up to 8 weeks
measure: Change From Baseline in the Bedtime Resistance Subscale of Child's Sleep Habits Questionnaire (CSHQ) at Week 8 - LOCF
timeFrame: Baseline and up to 8 weeks
measure: Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF
timeFrame: up to 8 weeks
measure: Change From Baseline in Mean Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Week 8 - LOCF
timeFrame: Baseline and up to 8 weeks
measure: Change From Baseline in Systolic Blood Pressure at Week 8 - LOCF
timeFrame: Baseline and up to 8 weeks
measure: Change From Baseline in Diastolic Blood Pressure at Week 8 - LOCF
timeFrame: Baseline and up to 8 weeks
measure: Change From Baseline in Pulse Rate at Week 8 - LOCF
timeFrame: Baseline and up to 8 weeks
measure: Change From Baseline in Oral Temperature at Week 8 - LOCF
timeFrame: Baseline and up to 8 weeks
measure: Change From Baseline in Height at Week 8 - LOCF
timeFrame: Baseline and up to 8 weeks
measure: Change From Baseline in Weight at Week 8 - LOCF
timeFrame: Baseline and up to 8 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Clinical Study Centers, LLC
state: Arkansas
city: El Centro
country: United States
facility: Valley Clinical Research, Inc.
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates, Inc.
state: California
city: San Diego
country: United States
facility: Psychiatric centers at San Diego, Feighner Research
state: California
city: Wildomar
country: United States
facility: Elite Clinical Trials, Inc.
state: California
city: Bradenton
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Janus Centerfor Psychiatric Research
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Marietta
country: United States
facility: Northwest Clincial Research Group
state: Georgia
city: Boise
country: United States
facility: Mountain West Clinical Trials
state: Idaho
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
city: Oak Brook
country: United States
facility: American Medical research, Inc.
state: Illinois
city: Indianapolis
country: United States
facility: Goldpoint Clinical Research, LLC
state: Indiana
city: Terre Haute
country: United States
facility: Clinco
state: Indiana
city: Overland Park
country: United States
facility: Psychiatric Associates
state: Kansas
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Paducah
country: United States
facility: Four Rivers Clinical Research, Inc.
state: Kentucky
city: New Orleans
country: United States
facility: Louisiana Research Associates, Inc.
state: Louisiana
city: Rockville
country: United States
facility: Marc Hertzman, M.D., P.C.
state: Maryland
city: Rochester Hills
country: United States
facility: Richester Center for Behavioral Medicine
state: Michigan
city: Saint Charles
country: United States
facility: Midwest research Group
state: Missouri
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioral Medicine, Inc.
state: Nevada
city: Toms River
country: United States
facility: Children's Specialized Hospital
state: New Jersey
city: Fargo
country: United States
facility: Innovis Health
state: North Dakota
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Philadelphia
country: United States
facility: CRI Worldwide, LLC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute and Clinic
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Clinical Trials
state: Texas
city: Houston
country: United States
facility: Claghorn-Lesem research Clinic
state: Texas
city: Lake Jackson
country: United States
facility: R/D Clinical Research, Inc.
state: Texas
city: Lubbock
country: United States
facility: Western Clinical Investigations
state: Texas
city: San Antonio
country: United States
facility: Cerebral Research, LLC
state: Texas
city: Burlington
country: United States
facility: Vermont Clinical Study Center
state: Vermont
city: Herndon
country: United States
facility: NeuroScience Inc
state: Virginia
city: Richmond
country: United States
facility: Alliance Research Group, LLC
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Vancouver
country: Canada
facility: BC Women;s Hospital and Health Centre
state: British Columbia
city: Toronto
country: Canada
facility: Toronto ADHD Clinic
state: Ontario
city: Whitby
country: Canada
facility: ADHD Clinical/ The Kids Clinic
state: Ontario
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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 Psychiatry. 2013 Sep;52(9):921-30. doi: 10.1016/j.jaac.2013.06.006. Epub 2013 Aug 1.
citation: Stein MA, Sikirica V, Weiss MD, Robertson B, Lyne A, Newcorn JH. Does Guanfacine Extended Release Impact Functional Impairment in Children with Attention-Deficit/Hyperactivity Disorder? Results from a Randomized Controlled Trial. CNS Drugs. 2015 Nov;29(11):953-62. doi: 10.1007/s40263-015-0291-6.