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)

May 14, 2021 updated by: Shire

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

340

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • BC Women;s Hospital and Health Centre
    • Ontario
      • Toronto, Ontario, Canada, M4S 1Y2
        • Toronto ADHD Clinic
      • Whitby, Ontario, Canada, L1N8M7
        • ADHD Clinical/ The Kids Clinic
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N-OW8
        • Royal University Hospital
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Clinical Study Centers, LLC
    • California
      • El Centro, California, United States, 92243
        • Valley Clinical Research, Inc.
      • Rolling Hills Estates, California, United States, 90274
        • Peninsula Research Associates, Inc.
      • San Diego, California, United States, 92108
        • Psychiatric Centers at San Diego, Feighner Research
      • Wildomar, California, United States, 92595
        • Elite Clinical Trials, Inc.
    • Florida
      • Bradenton, Florida, United States, 34208
        • Florida Clinical Research Center, LLC
      • Gainesville, Florida, United States, 32607
        • Sarkis Clinical Trials
      • Jacksonville, Florida, United States, 32216
        • Clinical Neuroscience Solutions, INC.
      • Maitland, Florida, United States, 32751
        • Florida Clinical Research Center, LLC
      • Orlando, Florida, United States, 32806
        • Clinical Neuroscience Solutions, INC.
      • West Palm Beach, Florida, United States, 33407
        • Janus Centerfor Psychiatric Research
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Atlanta Center for Medical Research
      • Marietta, Georgia, United States, 30060
        • Northwest Clincial Research Group
    • Idaho
      • Boise, Idaho, United States, 83704
        • Mountain West Clinical Trials
    • Illinois
      • Chicago, Illinois, United States, 60608
        • University of Illinois Chicago
      • Oak Brook, Illinois, United States, 60523
        • American Medical Research, Inc.
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Goldpoint Clinical Research, LLC
      • Terre Haute, Indiana, United States, 47802
        • Clinco
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Psychiatric Associates
      • Overland Park, Kansas, United States, 66212
        • Vince and Associates Clinical Research
    • Kentucky
      • Paducah, Kentucky, United States, 42003
        • Four Rivers Clinical Research, Inc.
    • Louisiana
      • New Orleans, Louisiana, United States, 70114
        • Louisiana Research Associates, Inc.
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Marc Hertzman, M.D., P.C.
    • Michigan
      • Rochester Hills, Michigan, United States, 48307
        • Richester Center for Behavioral Medicine
    • Missouri
      • Saint Charles, Missouri, United States, 63301
        • Midwest Research Group
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Center for Psychiatry and Behavioral Medicine, Inc.
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Children's Specialized Hospital
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Innovis Health
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • IPS Research Company
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19139
        • CRI Worldwide, LLC
      • Pittsburgh, Pennsylvania, United States, 15213
        • Western Psychiatric Institute and Clinic
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions, INC.
    • Texas
      • Austin, Texas, United States, 78756
        • FutureSearch Clinical Trials
      • Houston, Texas, United States, 77008
        • Claghorn-Lesem Research Clinic
      • Lake Jackson, Texas, United States, 77566
        • R/D Clinical Research, Inc.
      • Lubbock, Texas, United States, 79423
        • Western Clinical Investigations
      • San Antonio, Texas, United States, 78247
        • Cerebral Research, LLC
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Vermont Clinical Study Center
    • Virginia
      • Herndon, Virginia, United States, 20170
        • NeuroScience Inc
      • Richmond, Virginia, United States, 23230
        • Alliance Research Group, LLC
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Extended-release Guanfacine Hydrochloride (SPD503) AM
Drug: extended-release guanfacine hydrochloride (SPD503)
dosed in AM
Other Names:
  • Intuniv
EXPERIMENTAL: placebo
Drug: placebo
dosed in the AM or PM
EXPERIMENTAL: SPD503 PM
Drug: extended-release guanfacine hydrochloride
Dosed in the PM
Other Names:
  • Intuniv

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Attention-Deficit/Hyperactivity Disorder-Rating Scale-IV (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)
Time Frame: Baseline and up to 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF
Time Frame: Baseline and up to 8 weeks
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
Improvement on Clinical Global Impression-Improvement (CGI-I) Scale at Week 8 - LOCF
Time Frame: up to 8 weeks
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
Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 8 - LOCF
Time Frame: Baseline and up to 8 weeks
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
Change From Baseline in Health Utilities Index-2/3 (HUI 2/3) Scores at Week 8 - LOCF
Time Frame: Baseline and up to 8 weeks
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
Change From Baseline in Conner's Parent Rating Scale - Revised Short Version (CPRS-R:S) Score at Week 8 - LOCF
Time Frame: Baseline and up to 8 weeks
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
Change From Baseline in the Bedtime Resistance Subscale of Child's Sleep Habits Questionnaire (CSHQ) at Week 8 - LOCF
Time Frame: Baseline and up to 8 weeks
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
Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF
Time Frame: up to 8 weeks
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
Change From Baseline in Mean Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Week 8 - LOCF
Time Frame: Baseline and up to 8 weeks
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
Change From Baseline in Systolic Blood Pressure at Week 8 - LOCF
Time Frame: Baseline and up to 8 weeks
Baseline and up to 8 weeks
Change From Baseline in Diastolic Blood Pressure at Week 8 - LOCF
Time Frame: Baseline and up to 8 weeks
Baseline and up to 8 weeks
Change From Baseline in Pulse Rate at Week 8 - LOCF
Time Frame: Baseline and up to 8 weeks
Baseline and up to 8 weeks
Change From Baseline in Oral Temperature at Week 8 - LOCF
Time Frame: Baseline and up to 8 weeks
Baseline and up to 8 weeks
Change From Baseline in Height at Week 8 - LOCF
Time Frame: Baseline and up to 8 weeks
Baseline and up to 8 weeks
Change From Baseline in Weight at Week 8 - LOCF
Time Frame: Baseline and up to 8 weeks
Baseline and up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 17, 2009

Primary Completion (ACTUAL)

October 9, 2010

Study Completion (ACTUAL)

October 9, 2010

Study Registration Dates

First Submitted

October 19, 2009

First Submitted That Met QC Criteria

October 19, 2009

First Posted (ESTIMATE)

October 20, 2009

Study Record Updates

Last Update Posted (ACTUAL)

June 8, 2021

Last Update Submitted That Met QC Criteria

May 14, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPD503-314

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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