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ADHDPhase 3NCT00734578

Efficacy and Safety of SPD503 in Combination With Psychostimulants

A Phase 3 study testing SPD503-AM and SPD503-PM in people with ADHD, run by Shire at 61 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
ADHD
What is being tested?
SPD503-AM and SPD503-PM
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
461 participants
Where
61 sitesUnited States
Study dates
2 Sep 2008to 10 Dec 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

61 sites in 1 country.

61 sites in 1 country

United States61 sites

  • FutureSearch Trials

    Austin, Texas, 75756

  • Peds Research Inc.

    Barnwell, South Carolina, 29812

  • Northwest Clinical Research Center

    Bellevue, Washington, 98004

  • Neurobehaviorial Medicine

    Bloomfield Hills, Michigan, 48302

  • Florida Clinical Research Center, LLC

    Bradenton, Florida, 32751

  • Vermont Clinical Study Center

    Burlington, Vermont, 05401

  • Massachussests General Hospital

    Cambridge, Massachusetts, 02138

  • Psychiatric Alliance of the Blue Ridge Clinical Research

    Charlottesville, Virginia, 22903

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Department of Psychiatry, The Ohio State University

    Columbus, Ohio, 43210

  • InSite Clinical Research

    DeSoto, Texas, 75115

  • Harmonex Neuroscience Research

    Dothan, Alabama, 36303

  • Duke University Medical Center ADHD Program

    Durham, North Carolina, 27705

  • Triangle Neuropsychiatry, PLLC

    Durham, North Carolina, 27707

  • Valley Clinical Research, Inc.

    El Centro, California, 92243

  • Oregon Center for Clinical Investigations, Inc

    Eugene, Oregon, 97401

  • Gulfcoast Clinical Research Center

    Fort Myers, Florida, 33912

  • Sarkis Clinical Trials

    Gainesville, Florida, 32607

  • NeuroScience, Inc

    Herndon, Virginia, 20170

  • Claghorn-Lesem Research Clinic, Inc.

    Houston, Texas, 77008

  • Red Oak Psychiatry Associates, PA

    Houston, Texas, 77090

  • Goldpoint Clinical Research, LLC

    Indianapolis, Indiana, 46260

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32216

  • The Center for Pharmaceutical Research

    Kansas City, Missouri, 64114

  • Centers for Psychiatry and Behavioral Medicine

    Las Vegas, Nevada, 89128

  • Premier Psychiatric Research Inst. LLC

    Lincoln, Nebraska, 68510

  • Clinical Study Centers, LLC

    Little Rock, Arkansas, 72205

  • Western Clinical Investigations

    Lubbock, Texas, 79423

  • Florida Clinical Research Center, LLC

    Maitland, Florida, 32751

  • Miami Children's Hospital

    Miami, Florida, 33155

  • Dominion Clinical Research

    Midlothian, Virginia, 23112

  • Bioscience Research, LLC

    Mount Kisco, New York, 10549

  • AMR-Baber Research, Inc.

    Naperville, Illinois, 60563

  • Pedia Research

    Newburgh, Indiana, 47630

  • American Medical Research, Inc

    Oak Brook, Illinois, 60523

  • IPS Research

    Oklahoma City, Oklahoma, 73103

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32806

  • Psychiatric Associates

    Overland Park, Kansas, 66211

  • Vince and Associates Clinical Research

    Overland Park, Kansas, 66212

  • Pedia Research, LLC

    Owensboro, Kentucky, 42301

  • Western Psychiatric Institute and Clinic

    Pittsburgh, Pennsylvania, 15065

  • Oregon Center for Clinical Investigations, INC (OCCI, Inc.)

    Portland, Oregon, 97210

  • Summit Research Network

    Portland, Oregon, 97210

  • Alliance Research Group

    Richmond, Virginia, 23230

  • Bayou City Research

    Richmond, Virginia, 23230

  • Rochester Center for Behavioral Medicine

    Rochester Hills, Michigan, 48307

  • Marc Hertzman, MD, PC

    Rockville, Maryland, 20852

  • Peninsula Research Associates

    Rolling Hills Estates, California, 90274

  • Midwest Research Group/St. Charles Psychiatric Associates

    Saint Charles, Missouri, 63301

  • Oregon Center for Clinical Investigations, Inc

    Salem, Oregon, 97301

  • Delmarva Family Resources

    Salisbury, Maryland, 21801

  • Cerebral Research, LLC

    San Antonio, Texas, 78247

  • UCSD Department of Psychiatry

    San Diego, California, 8620

  • University of California, San Francisco

    San Francisco, California, 94143

  • Melmed Center

    Scottsdale, Arizona, 85254

  • Richmond Behavioral Associates

    Staten Island, New York, 10312

  • Children's Specialized Hospital

    Toms River, New Jersey, 08755

  • Behavioral Medicine Center

    Troy, Michigan, 48083

  • Janus Center for Psychiatric Research

    West Palm Beach, Florida, 33407

  • Wharton Research Center

    Wharton, Texas, 77488

  • Elite Clinical Trials, Inc

    Wildomar, California, 92595

Other trials in United States

About this study

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)

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.

Conditions
ADHD
Being tested
SPD503-AM, SPD503-PM, Placebo
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPD503-AMDrug

    Also called Intuniv

    SPD503 (Guanfacine Extended Release)-AM Optimized 1-4mg

  • SPD503-PMDrug

    Also called Intuniv

    SPD503 (Guanfacine Extended Release)-PM Optimized 1-4mg

  • PlaceboDrug

    Placebo matched to Guanfacine Hydrochloride Extended Release

Study groups in NCT00734578
Study groupRoleWhat they receive
SPD503-AMExperimentalSPD503 (Guanfacine Extended Release)
Receives: Drug: SPD503-AM
SPD503-PMExperimentalSPD503 (Guanfacine Extended Release)
Receives: Drug: SPD503-PM
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    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.

    Measured: Baseline and weekly up to 8 weeks

Secondary outcomes (8)

  1. Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) 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 is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.

    Measured: Baseline and weekly up to 8 weeks

  2. 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)

    Measured: Baseline and weekly up to 8 weeks

  3. Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Morning Assessment (Before School)

    The index contains 10 items. Each item on the scale is scored from a range of 0 (reflecting never, seldom) to 3 (reflecting very often, very frequent) with total scores ranging from 0 to 30.

    Measured: Baseline and weekly up to 8 weeks

  4. Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Evening Assessment (Before Bedtime)

    The index contains 10 items. Each item on the scale is scored from a range of 0 (reflecting never, seldom) to 3 (reflecting very often, very frequent) with total scores ranging from 0 30.

    Measured: Baseline and weekly up to 8 weeks

  5. Percentage of Participants With Improvement on Parent Global Assessment (PGA) at Week 8 - LOCF

    Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.

    Measured: Baseline and week 8

  6. Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Week 8 - LOCF

    The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms.

    Measured: Baseline and weekly up to 8 weeks

  7. Change From Baseline in Before School Functioning Questionnaire (BSFQ) at Week 8 - LOCF

    This scale was designed to assess symptoms of ADHD that typically occur in the morning. The BSFQ consists of two components. The first, a 20-item scale with ratings from 0 (none) to 3 (severe) with a range of 0-60 followed by two questions answered with duration of time (in minutes). The second, a 14-item scale with ratings from 0 (no) to 2 (a lot) with a range of 0-28. The results reported here are from the 20-item scale. Lower scores are better.

    Measured: Baseline and weekly up to 8 weeks

  8. 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.

    Measured: Baseline and weekly up to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2008 (estimated)
  2. Study start2 Sep 2008
  3. Primary completion10 Dec 2009
  4. Study completion10 Dec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
461 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00734578
Sponsor's protocol ID
SPD503-313
Status last verified
Jun 2021
First submitted
12 Aug 2008
Last updated
14 Jun 2021
Data monitoring committee
No

Publications

  • 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.

    PubMed 22176941

  • 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.

    PubMed 25245353

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SPD503-AM and SPD503-PM in people with ADHD, run by Shire at 61 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: Baseline and weekly up to 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00734578, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.

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