Attention-Deficit/Hyperactivity DisorderPhase 3NCT00997984

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 study testing extended-release guanfacine hydrochloride (SPD503) and extended-release guanfacine hydrochloride in people with Attention-Deficit/Hyperactivity Disorder, run by Shire at 46 sites in 2 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 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. Read more about this study

Who is it for?: Ages 6 to 12 years
Conditions the study is for: Attention-Deficit/Hyperactivity Disorder
What is being tested?: extended-release guanfacine hydrochloride (SPD503) and extended-release guanfacine hydrochloride
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 340 participants
Where: 46 sitesin 2 countries
Study dates: 17 Nov 2009to 9 Oct 2010
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 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

6-12 years old
ADHD diagnosis
ADHD-RS-IV minimum score of 28
CGI-S score > or = 4

Who cannot join

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

Show all 10Show fewer

Significantly overweight
Weight of less than 55 lbs
Known allergy to SPD503
Abnormal urine drug and alcohol screen

Trial locations and contacts

46 sites in 2 countries.

Country

City, postcode or hospital

46 sites in 2 countries

United States42 sites

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

Other trials in United States

Canada4 sites

Royal University Hospital
Saskatoon, Saskatchewan, S7N-OW8
Toronto ADHD Clinic
Toronto, Ontario, M4S 1Y2
BC Women;s Hospital and Health Centre
Vancouver, British Columbia, V6H 3N1
ADHD Clinical/ The Kids Clinic
Whitby, Ontario, L1N8M7

Other trials in Canada

About this 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

Conditions: Attention-Deficit/Hyperactivity Disorder
Being tested: extended-release guanfacine hydrochloride (SPD503), placebo, extended-release guanfacine hydrochloride
Keywords: ADHD
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 hydrochloride (SPD503)Drug
Also called Intuniv
dosed in AM
placeboDrug
dosed in the AM or PM
extended-release guanfacine hydrochlorideDrug
Also called Intuniv
Dosed in the PM

Study groups in NCT00997984
Study group	Role	What they receive
Extended-release Guanfacine Hydrochloride (SPD503) AM	Experimental	Not described Receives: Drug: extended-release guanfacine hydrochloride (SPD503)
placebo	Experimental	Not described Receives: Drug: placebo
SPD503 PM	Experimental	Not described Receives: Drug: extended-release guanfacine hydrochloride

What is being measured

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

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.
Measured: Baseline and up to 8 weeks

Secondary outcomes (14)

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 up to 8 weeks
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.
Measured: up to 8 weeks
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.
Measured: Baseline and up to 8 weeks
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline and up to 8 weeks
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: up to 8 weeks
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.
Measured: Baseline and up to 8 weeks
Change From Baseline in Systolic Blood Pressure at Week 8 - LOCF
Measured: Baseline and up to 8 weeks
Change From Baseline in Diastolic Blood Pressure at Week 8 - LOCF
Measured: Baseline and up to 8 weeks
Change From Baseline in Pulse Rate at Week 8 - LOCF
Measured: Baseline and up to 8 weeks
Change From Baseline in Oral Temperature at Week 8 - LOCF
Measured: Baseline and up to 8 weeks
Change From Baseline in Height at Week 8 - LOCF
Measured: Baseline and up to 8 weeks
Change From Baseline in Weight at Week 8 - LOCF
Measured: Baseline and 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.

17 Nov 20099 Oct 2010

First posted20 Oct 2009 (estimated)
Study start17 Nov 2009
Primary completion9 Oct 2010
Study completion9 Oct 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Attention-Deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 340 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00997984
Sponsor's protocol ID: SPD503-314
Status last verified: May 2021
First submitted: 19 Oct 2009
Last updated: 8 Jun 2021
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 23972694
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.
PubMed 26547425

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00997984
Acronym / sponsor ID: SPD503-314
Conditions: Attention-Deficit/Hyperactivity Disorder
Keywords: ADHD
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 340 participants (actual)
Lead sponsor: ShireIndustry (pharma, biotech, devices)
Study start: 17 Nov 2009 (actual)
Primary completion: 9 Oct 2010 (actual)
Study completion: 9 Oct 2010 (actual)
First posted: 20 Oct 2009 (estimated)
Results: Posted 26 Oct 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Extended-release Guanfacine Hydrochloride (SPD503) AM	Experimental	Drug: extended-release guanfacine hydrochloride (SPD503)
placebo	Experimental	Drug: placebo
SPD503 PM	Experimental	Drug: extended-release guanfacine hydrochloride

Who may qualify

Ages: 6 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

6-12 years old
ADHD diagnosis
ADHD-RS-IV minimum score of 28
CGI-S score > or = 4

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
extended-release guanfacine hydrochloride (SPD503)Also: Intunivdosed in AM	Drug	Extended-release Guanfacine Hydrochloride (SPD503) AM
placebodosed in the AM or PM	Drug	placebo
extended-release guanfacine hydrochlorideAlso: IntunivDosed in the PM	Drug	SPD503 PM

Primary outcome

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.

14 secondary outcomes

Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF
Time frame: 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
Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 8 - LOCF
Time frame: 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
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
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
Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF
Time frame: 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
Change From Baseline in Systolic Blood Pressure at Week 8 - LOCF
Time frame: 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
Change From Baseline in Pulse Rate at Week 8 - LOCF
Time frame: Baseline and up to 8 weeks
Change From Baseline in Oral Temperature at Week 8 - LOCF
Time frame: Baseline and up to 8 weeks
Change From Baseline in Height at Week 8 - LOCF
Time frame: Baseline and up to 8 weeks
Change From Baseline in Weight at Week 8 - LOCF
Time frame: Baseline and up to 8 weeks

Results and safety

Results posted to the registry on 26 Oct 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	113	76
SPD503 AM	113	79
SPD503 PM	114	88

Primary outcome: 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. Least squares mean (Standard Error). Unit: Units on a scale

Measure	Placebo n = 110	SPD503 AM n = 104	SPD503 PM n = 111	All-Active n = 215
Value	-10.6 (1.20)	-20.0 (1.23)	-20.4 (1.19)	-20.2 (0.86)

Placebo vs All-Active: p <0.001, ANCOVA
Placebo vs SPD503 AM: p <0.001, ANCOVA
Placebo vs SPD503 PM: p <0.001, ANCOVA

Population analysed: Full Analysis Set (FAS) defined as all subjects who had taken at least 1 dose of investigational product during the study.

14 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 112 (0%)	64 of 112 (57.1%)	Not reported
SPD503 AM	1 of 107 (0.9%)	85 of 107 (79.4%)	Not reported
SPD503 PM	2 of 114 (1.8%)	95 of 114 (83.3%)	Not reported
All Active	3 of 221 (1.4%)	180 of 221 (81.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23972694Newcorn 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.
Derived from this study: PubMed 26547425Stein 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.

Related trials for Attention-Deficit/Hyperactivity Disorder

Enrolling by invitationPhase 3
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

46 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 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 8 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 46 sites in United States, Canada. 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. 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 26 Oct 2011). 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-IV (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF) (time frame: Baseline and 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 NCT00997984, 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 8 Jun 2021.