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Attention-deficit/Hyperactivity DisorderPhase 3NCT01081145

Maintenance of Efficacy of Extended-Release Guanfacine HCl in Children and Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)

A Phase 3 study testing Extended-release Guanfacine Hydrochloride in people with Attention-deficit/Hyperactivity Disorder, run by Shire at 81 sites in 10 countries.

Completed

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

Official record
Search all trials

Trial summary

The primary objective of this study is to evaluate the long-term maintenance of efficacy of Extended-Release Guanfacine HCl in children and adolescents (6-17 years) with attention-deficit/hyperactivity disorder (ADHD) who respond to an initial open-label, short term treatment with SPD503. Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Attention-deficit/Hyperactivity Disorder
What is being tested?
Extended-release Guanfacine Hydrochloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
528 participants
Where
81 sitesin 10 countries
Study dates
11 May 2010to 3 Jun 2013
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

  • Male or female, aged 6-17 years at the time of consent/assent at Screening/Visit 1.
  • Subject's parent or legally authorised representative (LAR) must provide signature of informed consent, and there must be documentation of assent (if applicable) by the subject indicating that the subject is aware of the investigational nature of the study and the required procedures and restrictions, in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 (1996) and applicable regulations before completing any study-related procedures at Screening/Visit 1.
  • Subject meets DSM-IV-TR criteria for a primary diagnosis of ADHD, combined subtype, hyperactive/impulsive subtype, or inattentive sub-type based on a detailed psychiatric evaluation using the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL).
  • Subject has a minimum ADHD-RS-IV total score of 32 at Enrolment/Visit 2.
  • Subject has a minimum CGI-S score of 4 at Enrolment/Visit 2.
  • Subject is functioning at an age-appropriate level intellectually, as deemed by the Investigator.
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  • Subject and parent/LAR understand, are willing, able, and likely to fully comply with the study requirements, procedures, and restrictions defined in this protocol.
  • Subject is able to swallow intact tablets.
  • Subject who is a female of child-bearing potential (FOCP), defined as 9 years of age or <9 years of age and is post-menarchal, must have a negative serum beta Human Chorionic Gonadotropin (hCG) pregnancy test at Screening/Visit 1 and a negative urine pregnancy test at Enrolment/Visit 2 and agree to comply with any applicable contraceptive requirements of the protocol.
  • Subject has a supine and standing BP measurement within the 95th percentile for age, gender, and height.

Who cannot join

  • Subject has a current, controlled (requiring a prohibited medication or behavioural modification program) or uncontrolled, comorbid psychiatric diagnosis, except oppositional defiant disorder (ODD), including any severe comorbid Axis II disorders or severe Axis I disorders such as post traumatic stress disorder, bipolar illness, psychosis, pervasive developmental disorder, obsessive-compulsive disorder, substance abuse disorder, or other symptomatic manifestations or lifetime history of bipolar illness, psychosis, or conduct disorder that, in the opinion of the Investigator, contraindicate SPD503 treatment or confound efficacy or safety assessments.
  • Subject has any condition or illness including clinically significant abnormal Screening/Visit 1 laboratory values which, in the opinion of the Investigator, represents an inappropriate risk to the subject and/or could confound the interpretation of the study.
  • Subject has a known history or presence of structural cardiac abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction problems (e.g., clinically significant heart block), exercise-related cardiac events including syncope and pre syncope, or clinically significant bradycardia.
  • Subject with orthostatic hypotension or a known history of controlled or uncontrolled hypertension.
  • Subject has clinically significant ECG findings as judged by the Investigator with consideration of the central ECG laboratory's interpretation.
  • Current use of any prohibited medication or other medications, including herbal supplements, that affect BP or heart rate or that have CNS effects or affect cognitive performance, such as sedating antihistamines and decongestant sympathomimetics (inhaled bronchodilators are permitted) or a history of chronic use of sedating medications [i.e., antihistamines]) in violation of the protocol specified washout criteria at Enrolment/Visit 2.
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  • Subject has used an investigational product within 30 days prior to Enrolment/Visit 2.
  • Subject is significantly overweight based on Centre for Disease Control and Prevention Body Mass Index (BMI)-for-age gender specific charts. Significantly overweight is defined as a BMI >95th percentile.
  • Children aged 6-12 years with a body weight of <25kg or adolescents aged 13-17 years with a body weight of <34kg or >91kg at Screening/Visit 1.
  • Subject has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to guanfacine hydrochloride or any components found in SPD503.
  • Clinically important abnormality on drug and alcohol screen (excluding the subject's current ADHD stimulant if applicable) at Screening/Visit 1.
  • Subject has a history of alcohol or other substance abuse or dependence, as defined by DSM-IV-TR (with the exception of nicotine) within the last 6 months.
  • Subject is female and is pregnant or currently lactating.
  • Subject failed screening or was previously enrolled in this study.
  • Subject is currently considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator (see protocol Section 7.2.4.2 for additional guidance).
  • History of failure to respond to an adequate trial of an alpha 2-agonist for the treatment of ADHD (consisting of an appropriate dose and adequate duration of therapy in the opinion of the Investigator).
  • Subject has a history of a seizure disorder (other than a single childhood febrile seizure occurring before the age of 3 years) or the presence of a serious tic disorder (including Tourette's syndrome).
  • Subject has another member of the same household currently participating in this study.

Trial locations and contacts

81 sites in 10 countries.

81 sites in 10 countries

United States27 sites

  • FutureSearch Clinical Trials

    Austin, Texas, 78756

  • Florida Clinical Research Center, LLC

    Bradenton, Florida, 34208

  • Ohio State University, Nisonger Center

    Columbus, Ohio, 43210

  • Harmonex Neuroscience Research

    Dothan, Alabama, 36303

  • Triangle Neuropsychiatry, PLLC

    Durham, North Carolina, 27707

  • Sarkis Clinical Trials

    Gainesville, Florida, 32607

  • Amedica Research Institute, Inc.

    Hialeah, Florida, 33013

  • Goldpoint Clinical Research, LLC

    Indianapolis, Indiana, 46260

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32216

  • Eastside Therapeutic Resource

    Kirkland, Washington, 98033

  • Center for Psychiatry and Behavioral Medicine, Inc.

    Las Vegas, Nevada, 89128

  • Clinical Study Centers, LLC

    Little Rock, Arkansas, 72205

  • Florida Clinical Research Center, LLC

    Maitland, Florida, 32751

  • AMR-Baber Research Inc.

    Naperville, Illinois, 60563

  • Louisiana Research Associates, Inc.

    New Orleans, Louisiana, 70114

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • IPS Research Company

    Oklahoma City, Oklahoma, 73103

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32806

  • CRI Worldwide, LLC

    Philadelphia, Pennsylvania, 19139

  • Alliance Research Group, LLC

    Richmond, Virginia, 23230

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

    Salem, Oregon, 97301

  • Delmarva Family Resources

    Salisbury, Maryland, 21801

  • ADHD Clinic of San Antonio

    San Antonio, Texas, 78247

  • Psychiatric Centers at San Diego, Feighner Research

    San Diego, California, 92108

  • Encompass Clinical Research - North Coast

    Spring Valley, California, 91978

  • Elite Clinical Trials, Inc.

    Wildomar, California, 92595

Other trials in United States

Germany9 sites

  • Emovis GmbH

    Berlin, 10629

  • Sozialpsychiatrisches Centrum Dr. med. Ralph Meyers

    Dorsten, North Rhine-Westphalia, 46282

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, 79104

  • Friedrich-Schiller-Universitat Jena

    Jena, Thuringia, 07743

  • Klinikum der Johannes-Gutenberg-Universität Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Praxis Dr. med. Dipl. Psych. Anton Lindermüller

    München, Bavaria, 81241

  • Center for Pediatric Clinical Studies

    Tübingen, Baden-Wurttemberg, 72076

  • Universitätsklinik Ulm

    Ulm, Baden-Wurttemberg, 89075

  • Medizinisches Studienzentrum Wurzburg

    Würzburg, Bavaria, 97070

Other trials in Germany

Belgium8 sites

  • Cliniques Universitaires Saint Luc

    Brussels, 1200

  • Universitair Ziekenhuis Gent

    Ghent, Oost-vlaanderen, 9000

  • Huisartspraktijk Jaak Mortelmans

    Ham, 3945

  • Ziekenhuis Netwerk Antwerpen

    Hoboken, Antwerpen, 2660

  • Universitair Ziekenhuis Brussel

    Jette, Brussels Capital, 1090

  • Centre de référence Neuropédiatrique Multidisciplinaire

    Namur, 5000

  • Psypluriel

    Uccle, 1180

  • Ziekenhuis Inkendaal Koninklijke Instelling v.z.w.

    Vlezenbeek, 1602

Other trials in Belgium

France8 sites

  • Centre Hospitalier Universitaire d'Amiens, Hôpital Nord

    Amiens, Picardie, 80054

  • Centre Hospitalier Universitaire Bocage-Hôpital d'enfants

    Dijon, 21033

  • Hôpital Gui de Chauliac

    Montpellier, Languedoc-roussillon, 34295

  • Hopitaux Pediatriques de Nice - CHI Lenval

    Nice, Provcence Alpes Cote D'Azur, 06200

  • Hopital Robert Debre Centre pediatrique des pathologies du sommeil

    Paris, 75 015

  • Hopital Robert-Debre'

    Paris, 75935

  • Centre Hospitalier de Rouffach

    Rouffach, Alsace, 68250

  • Hopital Gatien de Clocheville CHU de Tours

    Tours, 37 000

Other trials in France

Italy7 sites

  • IRCCS Fondazione Stella Maris

    Calambrone, Pisa, 56018

  • Azienda Ospedaliero-Universitaria Policlinico-Vittorio

    Catania, 95123

  • Azienda Osp. Fatebenefratelli - Polo Territoriale UONPIA

    Milan, 20129

  • Azienda ULSS 16 Padova

    Padova, 35143

  • Azienda Ospedaliera "Guido Salvini"

    Rho, Milan, 20017

  • Drottning Silvias Barnsjukhus

    Roma, 00168

  • Università Cattolica del Sacro Cuore

    Roma, 00168

Other trials in Italy

Spain7 sites

  • Hospital Fundacion Alcorcon

    Alcorcón, Madrid, 289221

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Policlínica Guipuzkoa

    Donostia / San Sebastian, Guipuzcoa, 20009

  • Hospital Infanta Leonor

    Madrid, 28031

  • Hospital Son Llàtzer, Laboratorio de Neurociencias IUNICS

    Palma, Balearic Islands, 07198

  • Clínica Universitaria de Navarra

    Pamplona, Navarre, 31008

  • Instituto Valenciano de Neurología Pediatrica

    Valencia, 46010

Other trials in Spain

United Kingdom7 sites

  • Thurrock Community Hospital

    Grays, RM16 2PX

  • Royal Liverpool University Hospital

    Liverpool, L12 2AP

  • Norfolk Community Health and Care NHS Trust

    Norwich, England, NR4 7PA

  • Ryegate Children's Centre

    Sheffield, England, S10 5DD

  • Centenary House Child and Adolescent Mental Health Services

    Sheffield, England, S6 3BR

  • Lister Hospital

    Stevenage, SG1 4AB

  • Queen Elizabeth II Hospital

    Welwyn Garden City, England, AL7 4HQ

Other trials in United Kingdom

Canada4 sites

  • JPM van Stralen Medicine Professional Corporation

    Ottawa, Ontario, K2G1W2

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N-OW8

  • Children's and Women's Health Centre of British Columbia

    Vancouver, British Columbia, V6H3N1

  • ADHD Clinic/The Kid's Clinic

    Whitby, Ontario, L1N8M7

Other trials in Canada

Netherlands3 sites

  • FlevoResearch

    Almere Stad, Flevoland, 1311 RL

  • Academisch Ziekenhuis Maastricht

    Maastricht, Limburg, 6229 HX

  • Mondriaan Zorggroep Heerlen, Kinder en Jeugdp sychiatrie

    Maastricht, 6229

Other trials in Netherlands

Sweden1 site

  • Barn och Ungdomsmedicin klinik Mölnlycke

    Mölnlycke, 435 30

Other trials in Sweden

About this study

Official title: A Phase 3, Double-blind, Placebo-controlled, Multicentre, Randomised Withdrawal, Long-term Maintenance of Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 With Attention Deficit/Hyperactivity Disorder

The primary objective of this study is to evaluate the long-term maintenance of efficacy of Extended-Release Guanfacine HCl in children and adolescents (6-17 years) with attention-deficit/hyperactivity disorder (ADHD) who respond to an initial open-label, short term treatment with SPD503.

Being tested
Extended-release Guanfacine Hydrochloride, 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.

  • Extended-release Guanfacine HydrochlorideDrug

    The test product will be provided as 1, 2, 3, and 4mg tablets. Subjects will be administered a once-daily dose between 1-7mg/day depending on age and weight.

  • PlaceboOther

    Matching placebo will be provided as 1, 2, 3, and 4mg tablets. Subjects will be administered a once-daily dose of placebo between 1-7mg/day depending on age and weight.

Study groups in NCT01081145
Study groupRoleWhat they receive
Extended-release Guanfacine HClExperimentalNot described
Receives: Drug: Extended-release Guanfacine Hydrochloride
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

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

  1. Percentage of Participants With Treatment Failures During the Double-Blind Randomized-Withdrawal Phase

    Treatment failure was defined as >= 50% increase (worsening) in ADHD-RS-IV total score and a >= 2 point increase (worsening) in CGI-S score compared with the respective scores at the Double-blind Randomized-withdrawal Baseline Visit at 2 consecutive Double-blind Randomized-withdrawal Phase visits. Subjects meeting these criteria were regarded as treatment failures regardless of whether or not they were withdrawn. All subjects who discontinued the study for any reason were regarded as treatment failures for the primary analysis.

    Measured: 26 weeks

Secondary outcomes (13)

  1. Time to Treatment Failure During the Double-Blind Randomized-Withdrawal Phase

    Treatment failure was defined as >= 50% increase (worsening) in ADHD-RS-IV total score and a >= 2 point increase (worsening) in CGI-S score compared with the respective scores at the Double-blind Randomized-withdrawal Baseline Visit at 2 consecutive Double-blind Randomized-withdrawal Phase visits. Subjects meeting these criteria were regarded as treatment failures regardless of whether or not they were withdrawn. All subjects who discontinued the study for any reason were regarded as treatment failures for the primary analysis.

    Measured: 26 weeks

  2. Change From Double-Blind Randomized-Withdrawal Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 26 of the Double-Blind Randomized-Withdrawal Phase - 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 week 26

  3. Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on Clinical Global Impression-Severity of Illness (CGI-S) Scale During the Double-Blind Randomized-Withdrawal Phase - LOCF

    CGI-S assesses the severity of the subject's condition on a 7-point scale: 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill)

    Measured: 26 weeks

  4. Change From Double-Blind Randomized-Withdrawal Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Week 26 of the Double-Blind Randomized-Withdrawal Phase - 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). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.

    Measured: Baseline and week 26

  5. Health Utilities Index-2/3 (HUI 2/3) Scores During the Double-Blind Randomized-Withdrawal Phase - 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.

    Measured: 26 weeks

  6. Columbia-Suicide Severity Rating Scale During Double-Blind Randomized-Withdrawal Phase

    C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.

    Measured: 26 weeks

  7. Change From Open-Label Baseline in ADHD-RS-IV Total Score at Week 13 of the Open-Label Phase - 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 13 weeks

  8. Percentage of Responders in the Open-Label Phase - LOCF

    Response is defined as a percentage decrease (improvement) from Baseline in the ADHD-RS-IV total score of >=30% and a CGI-S score of 1 or 2.

    Measured: 13 weeks

  9. Percent of Subjects With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores During Open-Label Phase - 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: 13 weeks

  10. Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on CGI-S Scale During the Open-Label Phase - LOCF

    CGI-S assesses the severity of the subject's condition on a 7-point scale: 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill)

    Measured: 13 weeks

  11. Change From Open-Label Baseline in WFIRS-P Global Score at Week 13 of the Open-Label Phase - 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). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.

    Measured: Baseline and week 13

  12. HUI 2/3 Scores During the Open-Label Phase - 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.

    Measured: 13 weeks

  13. Columbia-Suicide Severity Rating Scale During Open-Label Phase

    C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.

    Measured: 13 weeks

Timeline

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

  1. First posted5 Mar 2010 (estimated)
  2. Study start11 May 2010
  3. Primary completion3 Jun 2013
  4. Study completion3 Jun 2013

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
528 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01081145
Sponsor's protocol ID
SPD503-315
Other IDs
2009-018161-12, 2009
Status last verified
Jun 2021
First submitted
3 Mar 2010
Last updated
14 Jun 2021

Publications

  • Newcorn JH, Harpin V, Huss M, Lyne A, Sikirica V, Johnson M, Ramos-Quiroga JA, van Stralen J, Dutray B, Sreckovic S, Bloomfield R, Robertson B. Extended-release guanfacine hydrochloride in 6-17-year olds with ADHD: a randomised-withdrawal maintenance of efficacy study. J Child Psychol Psychiatry. 2016 Jun;57(6):717-28. doi: 10.1111/jcpp.12492. Epub 2016 Feb 12.

    PubMed 26871297

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Extended-release Guanfacine Hydrochloride in people with Attention-deficit/Hyperactivity Disorder, run by Shire at 81 sites in 10 countries.

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 10 inclusion and 18 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 81 sites in United States, Germany, Belgium, France, Italy and 5 more countries. 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 9 Jun 2014). 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?

Percentage of Participants With Treatment Failures During the Double-Blind Randomized-Withdrawal Phase (time frame: 26 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 NCT01081145, which also lists 1 linked publication.

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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