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)
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
1 other identifier
interventional
340
2 countries
46
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2009
Shorter than P25 for phase_3
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2009
CompletedFirst Posted
Study publicly available on registry
October 20, 2009
CompletedStudy Start
First participant enrolled
November 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 9, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 9, 2010
CompletedResults Posted
Study results publicly available
October 26, 2011
CompletedJune 8, 2021
May 1, 2021
11 months
October 19, 2009
September 16, 2011
May 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (14)
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF
Baseline and up to 8 weeks
Improvement on Clinical Global Impression-Improvement (CGI-I) Scale at Week 8 - LOCF
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
Change From Baseline in Health Utilities Index-2/3 (HUI 2/3) Scores at Week 8 - LOCF
Baseline and up to 8 weeks
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
- +9 more secondary outcomes
Study Arms (3)
Extended-release Guanfacine Hydrochloride (SPD503) AM
EXPERIMENTALplacebo
EXPERIMENTALSPD503 PM
EXPERIMENTALInterventions
dosed in AM
Eligibility Criteria
You may qualify if:
- years old
- ADHD diagnosis
- ADHD-RS-IV minimum score of 28
- CGI-S score \> or = 4
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (46)
Clinical Study Centers, LLC
Little Rock, Arkansas, 72205, United States
Valley Clinical Research, Inc.
El Centro, California, 92243, United States
Peninsula Research Associates, Inc.
Rolling Hills Estates, California, 90274, United States
Psychiatric centers at San Diego, Feighner Research
San Diego, California, 92108, United States
Elite Clinical Trials, Inc.
Wildomar, California, 92595, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, 34208, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32216, United States
Florida Clinical Research Center, LLC
Maitland, Florida, 32751, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806, United States
Janus Centerfor Psychiatric Research
West Palm Beach, Florida, 33407, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30308, United States
Northwest Clincial Research Group
Marietta, Georgia, 30060, United States
Mountain West Clinical Trials
Boise, Idaho, 83704, United States
University of Illinois Chicago
Chicago, Illinois, 60608, United States
American Medical research, Inc.
Oak Brook, Illinois, 60523, United States
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, 46260, United States
Clinco
Terre Haute, Indiana, 47802, United States
Psychiatric Associates
Overland Park, Kansas, 66211, United States
Vince and Associates Clinical Research
Overland Park, Kansas, 66212, United States
Four Rivers Clinical Research, Inc.
Paducah, Kentucky, 42003, United States
Louisiana Research Associates, Inc.
New Orleans, Louisiana, 70114, United States
Marc Hertzman, M.D., P.C.
Rockville, Maryland, 20852, United States
Richester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307, United States
Midwest research Group
Saint Charles, Missouri, 63301, United States
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, 89128, United States
Children's Specialized Hospital
Toms River, New Jersey, 08755, United States
Innovis Health
Fargo, North Dakota, 58104, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
CRI Worldwide, LLC
Philadelphia, Pennsylvania, 19139, United States
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
FutureSearch Clinical Trials
Austin, Texas, 78756, United States
Claghorn-Lesem research Clinic
Houston, Texas, 77008, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566, United States
Western Clinical Investigations
Lubbock, Texas, 79423, United States
Cerebral Research, LLC
San Antonio, Texas, 78247, United States
Vermont Clinical Study Center
Burlington, Vermont, 05401, United States
NeuroScience Inc
Herndon, Virginia, 20170, United States
Alliance Research Group, LLC
Richmond, Virginia, 23230, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
BC Women;s Hospital and Health Centre
Vancouver, British Columbia, V6H 3N1, Canada
Toronto ADHD Clinic
Toronto, Ontario, M4S 1Y2, Canada
ADHD Clinical/ The Kids Clinic
Whitby, Ontario, L1N8M7, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N-OW8, Canada
Related Publications (2)
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.
PMID: 23972694RESULTStein 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.
PMID: 26547425DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2009
First Posted
October 20, 2009
Study Start
November 17, 2009
Primary Completion
October 9, 2010
Study Completion
October 9, 2010
Last Updated
June 8, 2021
Results First Posted
October 26, 2011
Record last verified: 2021-05