Clinical trial NCT00734578: Efficacy and Safety of SPD503 in Combination With Psychostimulants
Official title: A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multi-Center, Dose Optimization Study Evaluating the Efficacy and Safety of SPD503 in Combination With Psychostimulants in Children and Adolescents Aged 6-17 Years With a Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ADHD
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2008-08-14
Enrollment: 461
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of SPD503 in subjects with ADHD when co-administered with psychostimulants in children and adolescents aged 6-17 years with a diagnosis of ADHD with a sub-optimal, partial response to stimulants.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects with ADHD currently taking a stable dose of psychostimulant for at least 4 weeks
* Aged 6-17 years with a sub-optimal
* Partial response to stimulants
* Subjects must be \< 95th percentile for BMI with weight \>= 55lbs and \<= 176lbs

Primary outcomes:
measure: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)
timeFrame: Baseline and weekly up to 8 weeks
Secondary outcomes:
measure: Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 8 - LOCF
timeFrame: Baseline and weekly up to 8 weeks
measure: Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF
timeFrame: Baseline and weekly up to 8 weeks
measure: Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Morning Assessment (Before School)
timeFrame: Baseline and weekly up to 8 weeks
measure: Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Evening Assessment (Before Bedtime)
timeFrame: Baseline and weekly up to 8 weeks
measure: Percentage of Participants With Improvement on Parent Global Assessment (PGA) at Week 8 - LOCF
timeFrame: Baseline and week 8
measure: Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Week 8 - LOCF
timeFrame: Baseline and weekly up to 8 weeks
measure: Change From Baseline in Before School Functioning Questionnaire (BSFQ) at Week 8 - LOCF
timeFrame: Baseline and weekly up to 8 weeks
measure: Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF
timeFrame: Baseline and weekly up to 8 weeks
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Harmonex Neuroscience Research
state: Alabama
city: Scottsdale
country: United States
facility: Melmed Center
state: Arizona
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
state: California
city: San Diego
country: United States
facility: UCSD Department of Psychiatry
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
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: Fort Myers
country: United States
facility: Gulfcoast Clinical Research Center
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: Miami
country: United States
facility: Miami Children's Hospital
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Janus Center for Psychiatric Research
state: Florida
city: Naperville
country: United States
facility: AMR-Baber Research, Inc.
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: Newburgh
country: United States
facility: Pedia Research
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: Owensboro
country: United States
facility: Pedia Research, LLC
state: Kentucky
city: Rockville
country: United States
facility: Marc Hertzman, MD, PC
state: Maryland
city: Salisbury
country: United States
facility: Delmarva Family Resources
state: Maryland
city: Cambridge
country: United States
facility: Massachussests General Hospital
state: Massachusetts
city: Bloomfield Hills
country: United States
facility: Neurobehaviorial Medicine
state: Michigan
city: Rochester Hills
country: United States
facility: Rochester Center for Behavioral Medicine
state: Michigan
city: Troy
country: United States
facility: Behavioral Medicine Center
state: Michigan
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research
state: Missouri
city: Saint Charles
country: United States
facility: Midwest Research Group/St. Charles Psychiatric Associates
state: Missouri
city: Lincoln
country: United States
facility: Premier Psychiatric Research Inst. LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Centers for Psychiatry and Behavioral Medicine
state: Nevada
city: Toms River
country: United States
facility: Children's Specialized Hospital
state: New Jersey
city: Mount Kisco
country: United States
facility: Bioscience Research, LLC
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Durham
country: United States
facility: Duke University Medical Center ADHD Program
state: North Carolina
city: Durham
country: United States
facility: Triangle Neuropsychiatry, PLLC
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: Department of Psychiatry, The Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research
state: Oklahoma
city: Eugene
country: United States
facility: Oregon Center for Clinical Investigations, Inc
state: Oregon
city: Portland
country: United States
facility: Oregon Center for Clinical Investigations, INC (OCCI, Inc.)
state: Oregon
city: Portland
country: United States
facility: Summit Research Network
state: Oregon
city: Salem
country: United States
facility: Oregon Center for Clinical Investigations, Inc
state: Oregon
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute and Clinic
state: Pennsylvania
city: Barnwell
country: United States
facility: Peds Research Inc.
state: South Carolina
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research
state: Texas
city: Houston
country: United States
facility: Claghorn-Lesem Research Clinic, Inc.
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates, PA
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: Wharton
country: United States
facility: Wharton Research Center
state: Texas
city: Burlington
country: United States
facility: Vermont Clinical Study Center
state: Vermont
city: Charlottesville
country: United States
facility: Psychiatric Alliance of the Blue Ridge Clinical Research
state: Virginia
city: Herndon
country: United States
facility: NeuroScience, Inc
state: Virginia
city: Midlothian
country: United States
facility: Dominion Clinical Research
state: Virginia
city: Richmond
country: United States
facility: Alliance Research Group
state: Virginia
city: Richmond
country: United States
facility: Bayou City Research
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Wilens TE, Bukstein O, Brams M, Cutler AJ, Childress A, Rugino T, Lyne A, Grannis K, Youcha S. A controlled trial of extended-release guanfacine and psychostimulants for attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2012 Jan;51(1):74-85.e2. doi: 10.1016/j.jaac.2011.10.012. Epub 2011 Nov 25.
citation: Cutler AJ, Brams M, Bukstein O, Mattingly G, McBurnett K, White C, Rubin J. Response/remission with guanfacine extended-release and psychostimulants in children and adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2014 Oct;53(10):1092-101. doi: 10.1016/j.jaac.2014.08.001. Epub 2014 Aug 15.