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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)

Primary Purpose

Attention-Deficit/Hyperactivity Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
extended-release guanfacine hydrochloride (SPD503)
placebo
extended-release guanfacine hydrochloride
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention-Deficit/Hyperactivity Disorder focused on measuring ADHD

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Study Centers, LLC
  • Valley Clinical Research, Inc.
  • Peninsula Research Associates, Inc.
  • Psychiatric centers at San Diego, Feighner Research
  • Elite Clinical Trials, Inc.
  • Florida Clinical Research Center, LLC
  • Sarkis Clinical Trials
  • Clinical Neuroscience Solutions, Inc.
  • Florida Clinical Research Center, LLC
  • Clinical Neuroscience Solutions, Inc.
  • Janus Centerfor Psychiatric Research
  • Atlanta Center for Medical Research
  • Northwest Clincial Research Group
  • Mountain West Clinical Trials
  • University of Illinois Chicago
  • American Medical research, Inc.
  • Goldpoint Clinical Research, LLC
  • Clinco
  • Psychiatric Associates
  • Vince and Associates Clinical Research
  • Four Rivers Clinical Research, Inc.
  • Louisiana Research Associates, Inc.
  • Marc Hertzman, M.D., P.C.
  • Richester Center for Behavioral Medicine
  • Midwest research Group
  • Center for Psychiatry and Behavioral Medicine, Inc.
  • Children's Specialized Hospital
  • Innovis Health
  • IPS Research Company
  • CRI Worldwide, LLC
  • Western Psychiatric Institute and Clinic
  • Rhode Island Hospital
  • Clinical Neuroscience Solutions, Inc.
  • FutureSearch Clinical Trials
  • Claghorn-Lesem research Clinic
  • R/D Clinical Research, Inc.
  • Western Clinical Investigations
  • Cerebral Research, LLC
  • Vermont Clinical Study Center
  • NeuroScience Inc
  • Alliance Research Group, LLC
  • Northwest Clinical Research Center
  • BC Women;s Hospital and Health Centre
  • Toronto ADHD Clinic
  • ADHD Clinical/ The Kids Clinic
  • Royal University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Extended-release Guanfacine Hydrochloride (SPD503) AM

placebo

SPD503 PM

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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.
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.
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.
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.
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.
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.
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.
Change From Baseline in Systolic Blood Pressure at Week 8 - LOCF
Change From Baseline in Diastolic Blood Pressure at Week 8 - LOCF
Change From Baseline in Pulse Rate at Week 8 - LOCF
Change From Baseline in Oral Temperature at Week 8 - LOCF
Change From Baseline in Height at Week 8 - LOCF
Change From Baseline in Weight at Week 8 - LOCF

Full Information

First Posted
October 19, 2009
Last Updated
May 14, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT00997984
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
November 17, 2009 (Actual)
Primary Completion Date
October 9, 2010 (Actual)
Study Completion Date
October 9, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-Deficit/Hyperactivity Disorder
Keywords
ADHD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
340 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extended-release Guanfacine Hydrochloride (SPD503) AM
Arm Type
Experimental
Arm Title
placebo
Arm Type
Experimental
Arm Title
SPD503 PM
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
extended-release guanfacine hydrochloride (SPD503)
Other Intervention Name(s)
Intuniv
Intervention Description
dosed in AM
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
dosed in the AM or PM
Intervention Type
Drug
Intervention Name(s)
extended-release guanfacine hydrochloride
Other Intervention Name(s)
Intuniv
Intervention Description
Dosed in the PM
Primary Outcome Measure Information:
Title
Change From Baseline in Attention-Deficit/Hyperactivity Disorder-Rating Scale-IV (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)
Description
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.
Time Frame
Baseline and up to 8 weeks
Secondary Outcome Measure Information:
Title
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF
Description
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)
Time Frame
Baseline and up to 8 weeks
Title
Improvement on Clinical Global Impression-Improvement (CGI-I) Scale at Week 8 - LOCF
Description
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.
Time Frame
up to 8 weeks
Title
Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 8 - LOCF
Description
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.
Time Frame
Baseline and up to 8 weeks
Title
Change From Baseline in Health Utilities Index-2/3 (HUI 2/3) Scores at Week 8 - LOCF
Description
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.
Time Frame
Baseline and up to 8 weeks
Title
Change From Baseline in Conner's Parent Rating Scale - Revised Short Version (CPRS-R:S) Score at Week 8 - LOCF
Description
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.
Time Frame
Baseline and up to 8 weeks
Title
Change From Baseline in the Bedtime Resistance Subscale of Child's Sleep Habits Questionnaire (CSHQ) at Week 8 - LOCF
Description
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.
Time Frame
Baseline and up to 8 weeks
Title
Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF
Description
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.
Time Frame
up to 8 weeks
Title
Change From Baseline in Mean Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Week 8 - LOCF
Description
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.
Time Frame
Baseline and up to 8 weeks
Title
Change From Baseline in Systolic Blood Pressure at Week 8 - LOCF
Time Frame
Baseline and up to 8 weeks
Title
Change From Baseline in Diastolic Blood Pressure at Week 8 - LOCF
Time Frame
Baseline and up to 8 weeks
Title
Change From Baseline in Pulse Rate at Week 8 - LOCF
Time Frame
Baseline and up to 8 weeks
Title
Change From Baseline in Oral Temperature at Week 8 - LOCF
Time Frame
Baseline and up to 8 weeks
Title
Change From Baseline in Height at Week 8 - LOCF
Time Frame
Baseline and up to 8 weeks
Title
Change From Baseline in Weight at Week 8 - LOCF
Time Frame
Baseline and up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Study Centers, LLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Valley Clinical Research, Inc.
City
El Centro
State/Province
California
ZIP/Postal Code
92243
Country
United States
Facility Name
Peninsula Research Associates, Inc.
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Psychiatric centers at San Diego, Feighner Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Elite Clinical Trials, Inc.
City
Wildomar
State/Province
California
ZIP/Postal Code
92595
Country
United States
Facility Name
Florida Clinical Research Center, LLC
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Florida Clinical Research Center, LLC
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Janus Centerfor Psychiatric Research
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Northwest Clincial Research Group
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Mountain West Clinical Trials
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
University of Illinois Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Facility Name
American Medical research, Inc.
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
Goldpoint Clinical Research, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Clinco
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47802
Country
United States
Facility Name
Psychiatric Associates
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Vince and Associates Clinical Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Four Rivers Clinical Research, Inc.
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Louisiana Research Associates, Inc.
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70114
Country
United States
Facility Name
Marc Hertzman, M.D., P.C.
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Richester Center for Behavioral Medicine
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Facility Name
Midwest research Group
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Center for Psychiatry and Behavioral Medicine, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Children's Specialized Hospital
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Innovis Health
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
CRI Worldwide, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Western Psychiatric Institute and Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
FutureSearch Clinical Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Claghorn-Lesem research Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
R/D Clinical Research, Inc.
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
Western Clinical Investigations
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79423
Country
United States
Facility Name
Cerebral Research, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78247
Country
United States
Facility Name
Vermont Clinical Study Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
NeuroScience Inc
City
Herndon
State/Province
Virginia
ZIP/Postal Code
20170
Country
United States
Facility Name
Alliance Research Group, LLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
BC Women;s Hospital and Health Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3N1
Country
Canada
Facility Name
Toronto ADHD Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4S 1Y2
Country
Canada
Facility Name
ADHD Clinical/ The Kids Clinic
City
Whitby
State/Province
Ontario
ZIP/Postal Code
L1N8M7
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N-OW8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23972694
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.
Results Reference
result
PubMed Identifier
26547425
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.
Results Reference
derived

Learn more about this trial

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)

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